Tacrolimus Oral Capsule

Brand(s)
Hecoria, Prograf
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Accord Healthcare Inc. (2015-08-18)
Oldest Current Product
1994-04-08
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\TACROLIMUS
FDAOB
ORAL\CAPSULE\TACROLIMUS
SPL Active
ORAL\CAPSULE, GELATIN COATED\TACROLIMUS
ORAL\CAPSULE, GELATIN COATED\TACROLIMUS ANHYDROUS
ORAL\CAPSULE\TACROLIMUS
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\TACROLIMUS
ORAL\CAPSULE, GELATIN COATED\TACROLIMUS ANHYDROUS
ORAL\CAPSULE\TACROLIMUS ANHYDROUS
ORAL\CAPSULE\TACROLIMUS: TACROLIMUS ANHYDROUS

product(s) by strength(s)

tacrolimus 0.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690607PrografNDAFujisawa Healthcare, Inc.1998-08-24TACROLIMUSORALCAPSULE, GELATIN COATEDNDA0507087f667de1-9dfa-4bd6-8ba0-15ee2d78873b
2007819302Sandoz IncTACROLIMUSORALCAPSULE88ac83d9-798a-4610-b242-c443b43bdc88

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780616HecoriaANDANovartis Pharmaceuticals Corporation2011-12-20TACROLIMUSORALCAPSULEANDA06546195b03516-34b0-4438-a05c-918d80f70091
2003782045ANDAMylan Pharmaceuticals Inc.2013-06-24TACROLIMUSORALCAPSULEANDA09059645af3eda-caaa-4478-9372-95aa65adc9b3
3167290041ANDAAccord Healthcare Inc.2011-08-31TACROLIMUSORALCAPSULEANDA091195bd447ffa-9196-4c3c-accf-5adf29b84665
4507420207ANDAIngenus Pharmaceuticals, Llc2012-09-28TACROLIMUSORALCAPSULEANDA091195d9aeadf4-6605-47e0-b76a-9ac5de3fe949
5551110525ANDADr. Reddy'S Laboratories Ltd2010-05-14TACROLIMUSORALCAPSULEANDA09050961dee012-43af-0e9a-3843-9b9b91e022c4
6621750380ANDAKremers Urban Pharmaceuticals Inc.2015-07-30TACROLIMUSORALCAPSULE, GELATIN COATEDANDA090802468deb25-1661-5a4e-a6e8-bc5088ac5977
7643800720ANDAStrides Arcolab Limited2014-08-13TACROLIMUSORALCAPSULEANDA090687ed7d1495-3585-409d-94f1-b3d2469d222c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790817ANDAMylan Institutional Inc.2010-11-15TACROLIMUSORALCAPSULE003782045ANDA0905965f742224-618e-4f4c-bdec-7693be99c697
2551542676ANDACardinal Health2011-06-15TACROLIMUSORALCAPSULE167290041ANDA09119548865fd6-8837-447d-90ab-62e87e46d132
3680840449ANDAAmerican Health Packaging2013-07-17TACROLIMUSORALCAPSULE551110525ANDA09050993d03943-0655-44f6-b494-57bd1e336a34

tacrolimus 1 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690617PrografNDAFujisawa Healthcare, Inc.1994-04-08TACROLIMUSORALCAPSULE, GELATIN COATEDNDA0507087f667de1-9dfa-4bd6-8ba0-15ee2d78873b
2007812103Sandoz IncTACROLIMUSORALCAPSULE46ac55cf-d85e-4c34-bb33-f49e078c4a03

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780617HecoriaANDANovartis Pharmaceuticals Corporation2011-12-20TACROLIMUSORALCAPSULEANDA06546195b03516-34b0-4438-a05c-918d80f70091
2003782046ANDAMylan Pharmaceuticals Inc.2013-06-24TACROLIMUSORALCAPSULEANDA09059645af3eda-caaa-4478-9372-95aa65adc9b3
3009046425ANDAMajor2015-01-05TACROLIMUSORALCAPSULEANDA09119547429aa3-ed40-45e3-9ffb-870c715db8c1
4167290042ANDAAccord Healthcare Inc.2011-08-31TACROLIMUSORALCAPSULEANDA091195bd447ffa-9196-4c3c-accf-5adf29b84665
5507420208ANDAIngenus Pharmaceuticals, Llc2012-09-28TACROLIMUSORALCAPSULEANDA091195d9aeadf4-6605-47e0-b76a-9ac5de3fe949
6551110526ANDADr. Reddy'S Laboratories Ltd2010-05-14TACROLIMUSORALCAPSULEANDA09050961dee012-43af-0e9a-3843-9b9b91e022c4
7621750381ANDAKremers Urban Pharmaceuticals Inc.2015-07-30TACROLIMUSORALCAPSULE, GELATIN COATEDANDA090802468deb25-1661-5a4e-a6e8-bc5088ac5977

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790079ANDAKaiser Foundations Hospitals2010-12-10TACROLIMUSORALCAPSULE007812103ANDA0654616cef2a80-c7e5-44a2-92db-06082092bb35
2216950170PrografNDARebel Distributors Corp1994-04-08TACROLIMUS ANHYDROUSORALCAPSULE, GELATIN COATED004690617NDA050708f15b043d-fcfa-4ade-a3da-76700c0c5c2a
3433530178PrografNDAAphena Pharma Solutions - Tennessee, Llc1994-04-08TACROLIMUSORALCAPSULE, GELATIN COATED004690617NDA0507081e56c550-1c2b-4177-8e49-26303e9e335f
4510790818ANDAMylan Institutional Inc.2010-11-01TACROLIMUSORALCAPSULE003782046ANDA0905965f742224-618e-4f4c-bdec-7693be99c697
5551542675ANDACardinal Health2011-06-15TACROLIMUSORALCAPSULE167290042ANDA09119548865fd6-8837-447d-90ab-62e87e46d132
6551544779ANDACardinal Health2013-07-17TACROLIMUSORALCAPSULE680840450ANDA090509aafcc03e-b7d2-483a-8ace-4ff27cb768b3
7551545430ANDACardinal Health2009-08-10TACROLIMUSORALCAPSULE007812103ANDA06546193983865-362f-40a8-ba41-a8bcb99e35cb
8551545438ANDACardinal Health2009-08-10TACROLIMUSORALCAPSULE007819303ANDA065461ac20939e-5121-494c-bd13-879681ce5ecf
9551548705PrografNDACardinal Health1994-04-08TACROLIMUS ANHYDROUSORALCAPSULE, GELATIN COATED004690617NDA05070823b73332-cbb3-4155-8ad8-b24619cdea85
10636295423ANDABryant Ranch Prepack2012-10-30TACROLIMUSORALCAPSULE, GELATIN COATED621750380ANDA09080243e0d1e9-586c-4928-b1db-4dd36bd73cf5
11680840450ANDAAmerican Health Packaging2013-07-17TACROLIMUSORALCAPSULE551110526ANDA09050993d03943-0655-44f6-b494-57bd1e336a34

tacrolimus 5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690657PrografNDAFujisawa Healthcare, Inc.1994-04-08TACROLIMUSORALCAPSULE, GELATIN COATEDNDA0507087f667de1-9dfa-4bd6-8ba0-15ee2d78873b
2007819304Sandoz IncTACROLIMUSORALCAPSULE88ac83d9-798a-4610-b242-c443b43bdc88

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780618HecoriaANDANovartis Pharmaceuticals Corporation2011-12-20TACROLIMUSORALCAPSULEANDA06546195b03516-34b0-4438-a05c-918d80f70091
2003782047ANDAMylan Pharmaceuticals Inc.2013-06-24TACROLIMUSORALCAPSULEANDA09059645af3eda-caaa-4478-9372-95aa65adc9b3
3167290043ANDAAccord Healthcare Inc.2011-08-31TACROLIMUSORALCAPSULEANDA091195bd447ffa-9196-4c3c-accf-5adf29b84665
4507420209ANDAIngenus Pharmaceuticals, Llc2012-09-28TACROLIMUSORALCAPSULEANDA091195d9aeadf4-6605-47e0-b76a-9ac5de3fe949
5551110527ANDADr. Reddy'S Laboratories Ltd2010-05-14TACROLIMUSORALCAPSULEANDA09050961dee012-43af-0e9a-3843-9b9b91e022c4
6621750382ANDAKremers Urban Pharmaceuticals Inc.2015-07-30TACROLIMUSORALCAPSULE, GELATIN COATEDANDA090802468deb25-1661-5a4e-a6e8-bc5088ac5977

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913359ANDAWatson Laboratories, Inc.2010-07-06TACROLIMUSORALCAPSULEANDA090402aa756b80-11eb-4f67-abb8-8babcee728b2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790028ANDAMylan Institutional Inc.2010-11-01TACROLIMUSORALCAPSULE003782047ANDA0905965f742224-618e-4f4c-bdec-7693be99c697
2680840451ANDAAmerican Health Packaging2013-07-17TACROLIMUSORALCAPSULE551110527ANDA09050993d03943-0655-44f6-b494-57bd1e336a34

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065461TACROLIMUSSANDOZ INC2009-08-10ANDA065461_001, ANDA065461_002, ANDA065461_003
2ANDA090402TACROLIMUSTrueWATSON LABORATORIES INC2010-07-01ANDA090402_001
3ANDA090509TACROLIMUSDR REDDYS LABORATORIES LTD2010-05-12ANDA090509_001, ANDA090509_002, ANDA090509_003
4ANDA090596TACROLIMUSMYLAN PHARMACEUTICALS INC2010-09-17ANDA090596_001, ANDA090596_002, ANDA090596_003
5ANDA090687TACROLIMUSSTRIDES PHARMA GLOBAL PTE LTD2014-07-22ANDA090687_001, ANDA090687_002, ANDA090687_003
6ANDA090802TACROLIMUSPANACEA BIOTEC LTD2012-09-28ANDA090802_001, ANDA090802_002, ANDA090802_003
7ANDA091195TACROLIMUSACCORD HEALTHCARE INC2011-08-31ANDA091195_001, ANDA091195_002, ANDA091195_003
8NDA050708PROGRAFASTELLAS PHARMA US INC1994-04-08NDA050708_001, NDA050708_002, NDA050708_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065461_001RXTACROLIMUS (EQ 0.5MG BASE)ORALCAPSULEFalseAB2009-08-10TACROLIMUS
2ANDA065461_002RXTACROLIMUS (EQ 1MG BASE)ORALCAPSULEFalseAB2009-08-10TACROLIMUS
3ANDA065461_003RXTACROLIMUS (EQ 5MG BASE)ORALCAPSULEFalseAB2009-08-10TACROLIMUS
4ANDA090402_001discontinuedTACROLIMUS (EQ 5MG BASE)ORALCAPSULEFalse2010-07-01TACROLIMUS
5ANDA090509_001RXTACROLIMUS (EQ 0.5MG BASE)ORALCAPSULEFalseAB2010-05-12TACROLIMUS
6ANDA090509_002RXTACROLIMUS (EQ 1MG BASE)ORALCAPSULEFalseAB2010-05-12TACROLIMUS
7ANDA090509_003RXTACROLIMUS (EQ 5MG BASE)ORALCAPSULEFalseAB2010-05-12TACROLIMUS
8ANDA090596_001RXTACROLIMUS (EQ 0.5MG BASE)ORALCAPSULEFalseAB2010-09-17TACROLIMUS
9ANDA090596_002RXTACROLIMUS (EQ 1MG BASE)ORALCAPSULEFalseAB2010-09-17TACROLIMUS
10ANDA090596_003RXTACROLIMUS (EQ 5MG BASE)ORALCAPSULEFalseAB2010-09-17TACROLIMUS
11ANDA090687_001RXTACROLIMUS (EQ 0.5MG BASE)ORALCAPSULEFalseAB2014-07-22TACROLIMUS
12ANDA090687_002RXTACROLIMUS (EQ 1MG BASE)ORALCAPSULEFalseAB2014-07-22TACROLIMUS
13ANDA090687_003RXTACROLIMUS (EQ 5MG BASE)ORALCAPSULEFalseAB2014-07-22TACROLIMUS
14ANDA090802_001RXTACROLIMUS (EQ 0.5MG BASE)ORALCAPSULEFalseAB2012-09-28TACROLIMUS
15ANDA090802_002RXTACROLIMUS (EQ 1MG BASE)ORALCAPSULEFalseAB2012-09-28TACROLIMUS
16ANDA090802_003RXTACROLIMUS (EQ 5MG BASE)ORALCAPSULEFalseAB2012-09-28TACROLIMUS
17ANDA091195_001RXTACROLIMUS (EQ 0.5MG BASE)ORALCAPSULEFalseAB2011-08-31TACROLIMUS
18ANDA091195_002RXTACROLIMUS (EQ 1MG BASE)ORALCAPSULEFalseAB2011-08-31TACROLIMUS
19ANDA091195_003RXTACROLIMUS (EQ 5MG BASE)ORALCAPSULEFalseAB2011-08-31TACROLIMUS
20NDA050708_001RXTACROLIMUS (EQ 1MG BASE)ORALCAPSULEFalseAB1994-04-08PROGRAF
21NDA050708_002RXTACROLIMUS (EQ 5MG BASE)ORALCAPSULETrueAB1994-04-08PROGRAF
22NDA050708_003RXTACROLIMUS (EQ 0.5MG BASE)ORALCAPSULEFalseAB1998-08-24PROGRAF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11e56c550-1c2b-4177-8e49-26303e9e335f (view SPL)These highlights do not include all the information needed to use PROGRAFsafely and effectively. See full prescribing information for PROGRAF. PROGRAF (tacrolimus) capsules, USP PROGRAF (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-05-201433530178
223b73332-cbb3-4155-8ad8-b24619cdea85 (view SPL)PROGRAFtacrolimus capsulestacrolimus injection (for intravenous infusion only)prescriptionHuman PrescriptionCardinal HealthREPACK2012-04-041551548705
343e0d1e9-586c-4928-b1db-4dd36bd73cf5 (view SPL)These highlights do not include all the information needed to use Tacrolimus Capsules USP safely and effectively. See full prescribing information for Tacrolimus Capsules USP. Tacrolimus Capsules USP Initial U.S. Approval 1994 Rx OnlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-03-261000636295423
445af3eda-caaa-4478-9372-95aa65adc9b3 (view SPL)These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, USP for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-08-114003782045, 003782046, 003782047
5468deb25-1661-5a4e-a6e8-bc5088ac5977 (view SPL)These highlights do not include all the information needed to use Tacrolimus Capsules USP safely and effectively. See full prescribing information for Tacrolimus Capsules USP. Tacrolimus Capsules USP Initial U.S. Approval 1994 Rx OnlyprescriptionHuman PrescriptionKremers Urban Pharmaceuticals Inc.manufacture2015-07-309621750380, 621750381, 621750382
646ac55cf-d85e-4c34-bb33-f49e078c4a03 (view SPL)These highlights do not include all the information needed to use tacrolimus capsules safely and effectively. See full prescribing information for tacrolimus capsules. TACROLIMUS Capsules , USP for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionSandoz Inc2015-07-1710007812103, 007812102, 007812104
747429aa3-ed40-45e3-9ffb-870c715db8c1 (view SPL)These highlights do not include all the information needed to use tacrolimus safely and effectively. See full prescribing information for tacrolimus. Tacrolimus Capsules USP for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionMajor2015-01-051009046425
848865fd6-8837-447d-90ab-62e87e46d132 (view SPL)These highlights do not include all the information needed to use tacrolimus safely and effectively. See full prescribing information for tacrolimus. Tacrolimus Capsules USP for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionCardinal HealthREPACK2015-09-182551542675, 551542676
95f742224-618e-4f4c-bdec-7693be99c697 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2014-08-012510790028, 510790817, 510790818
1061dee012-43af-0e9a-3843-9b9b91e022c4 (view SPL)These highlights do not include all the information needed to use tacrolimus safely and effectively. See full prescribing information for tacrolimus. TACROLIMUS capsules USP, for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-06-227551110525, 551110526, 551110527
116cef2a80-c7e5-44a2-92db-06082092bb35 (view SPL)Tacrolimus CapsulesprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-12-101001790079
127f667de1-9dfa-4bd6-8ba0-15ee2d78873b (view SPL)These highlights do not include all the information needed to use PROGRAFsafely and effectively. See full prescribing information for PROGRAF. PROGRAF (tacrolimus) capsules, USP PROGRAF (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994prescriptionHuman PrescriptionFujisawa Healthcare, Inc.2015-05-3115004690607, 004690617, 004690657, 004693016Tacrolimus Injectable Solution
1388ac83d9-798a-4610-b242-c443b43bdc88 (view SPL)These highlights do not include all the information needed to use tacrolimus capsules safely and effectively. See full prescribing information for tacrolimus capsules. TACROLIMUS Capsules, USP for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionSandoz Inc2015-06-196007819302, 007819304, 007819303
1493983865-362f-40a8-ba41-a8bcb99e35cb (view SPL)Tacrolimus CapsulesprescriptionHuman PrescriptionCardinal HealthREPACK2011-04-261551545430
1593d03943-0655-44f6-b494-57bd1e336a34 (view SPL)These highlights do not include all the information needed to use tacrolimus safely and effectively. See full prescribing information for tacrolimus.Tacrolimus Capsules USP for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-185680840449, 680840450, 680840451
1695b03516-34b0-4438-a05c-918d80f70091 (view SPL)These highlights do not include all the information needed to use Hecoria safely and effectively. See full prescribing information for Hecoria. HecoriaTM (tacrolimus capsules, USP) Initial U.S. Approval: 1994prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2013-09-017000780616, 000780617, 000780618
17aa756b80-11eb-4f67-abb8-8babcee728b2 (view SPL)Tacrolimus CapsulesprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-08-0711005913359
18aafcc03e-b7d2-483a-8ace-4ff27cb768b3 (view SPL)These highlights do not include all the information needed to use tacrolimus safely and effectively. See full prescribing information for tacrolimus.Tacrolimus Capsules USP for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionCardinal HealthREPACK2013-08-211551544779
19ac20939e-5121-494c-bd13-879681ce5ecf (view SPL)These highlights do not include all the information needed to use tacrolimus capsules safely and effectively. See full prescribing information for tacrolimus capsules. TACROLIMUS Capsules, USP for oral useInitial U.S. Approval: 1994prescriptionHuman PrescriptionCardinal HealthREPACK2014-04-245551545438
20bd447ffa-9196-4c3c-accf-5adf29b84665 (view SPL)These highlights do not include all the information needed to use tacrolimus safely and effectively. See full prescribing information for tacrolimus. Tacrolimus Capsules USP for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-08-185167290041, 167290042, 167290043
21d9aeadf4-6605-47e0-b76a-9ac5de3fe949 (view SPL)These highlights do not include all the information needed to use tacrolimus safely and effectively. See full prescribing information for tacrolimus.Tacrolimus CapsulesInitial U.S. Approval: 1994prescriptionHuman PrescriptionIngenus Pharmaceuticals, LlcMANUFACTURE2012-08-221507420207, 507420208, 507420209
22ed7d1495-3585-409d-94f1-b3d2469d222c (view SPL)These highlights do not include all the information needed to use tacrolimus capsules, USP safely and effectively. See full prescribing information for tacrolimus capsules, USP.Tacrolimus Capsules, USPInitial U.S. Approval: 1994prescriptionHuman PrescriptionStrides Arcolab Limitedanalysis, manufacture, pack2015-10-085643800720
23f15b043d-fcfa-4ade-a3da-76700c0c5c2a (view SPL)PROGRAFtacrolimus capsulestacrolimus injection (for intravenous infusion only)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-281216950170

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII