Calcitriol Oral Capsule

Brand(s)
Rocaltrol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Validus Pharmaceuticals Llc (2010-08-01)
Oldest Current Product
2001-10-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\CALCITRIOL
FDAOB
ORAL\CAPSULE\CALCITRIOL
SPL Active
ORAL\CAPSULE, GELATIN COATED\CALCITRIOL
ORAL\CAPSULE, LIQUID FILLED\CALCITRIOL
ORAL\CAPSULE\CALCITRIOL
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\CALCITRIOL
ORAL\CAPSULE, LIQUID FILLED\CALCITRIOL
ORAL\CAPSULE\CALCITRIOL

product(s) by strength(s)

calcitriol 0.00025 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1306980143RocaltrolNDAValidus Pharmaceuticals Llc2009-08-10CALCITRIOLORALCAPSULE, GELATIN COATEDNDA018044d1013494-bf62-4e68-9f0c-e6571137f20f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540007ANDARoxane Laboratories, Inc2006-03-27CALCITRIOLORALCAPSULEANDA076917cdcaffc6-e14e-4607-b77b-fc78a8382f60
2000930657ANDATeva Pharmaceuticals Usa Inc2001-10-15CALCITRIOLORALCAPSULE, LIQUID FILLEDANDA075765ae2d0165-1b19-4406-9f28-f4b1579c3dbf
3231550118ANDAHeritage Pharmaceuticals Inc.2013-05-29CALCITRIOLORALCAPSULE, LIQUID FILLEDANDA091174aaf62f0f-bd93-43f1-96f2-e4f001ea7328
4633040239NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2009-08-26CALCITRIOLORALCAPSULENDA01804466a69351-5b09-4368-a9fa-acf81b5ad882
5643800723ANDAStrides Arcolab Limited2015-01-06CALCITRIOLORALCAPSULEANDA091356bebefb2a-7365-48e2-9681-83ed4b41e26e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790069RocaltrolNDAKaiser Foundations Hospitals2010-08-09CALCITRIOLORALCAPSULE, GELATIN COATED306980143NDA018044e26e13c4-7e45-4e66-8c0d-7fc68e24cdd5
2433530034ANDAAphena Pharma Solutions - Tennessee, Llc2006-03-27CALCITRIOLORALCAPSULE000540007ANDA076917167a669f-7b7e-46ea-9331-567bf19d8787
3433530633RocaltrolNDAAphena Pharma Solutions - Tennessee, Llc2009-08-10CALCITRIOLORALCAPSULE, GELATIN COATED306980143NDA0180441b2aa7df-0f38-460e-b1f1-d7473be4ab3c
4548684584ANDAPhysicians Total Care, Inc.2005-12-02CALCITRIOLORALCAPSULE, LIQUID FILLED000930657ANDA07576584262b69-df29-41d0-9e97-6e1188096aeb
5551548251ANDACardinal Health2009-10-29CALCITRIOLORALCAPSULE, LIQUID FILLED000930657ANDA075765d3d69786-ac48-4a71-bbd8-83172e86d577
6604290133ANDAGolden State Medical Supply, Inc.2014-12-26CALCITRIOLORALCAPSULE, LIQUID FILLED231550118ANDA091174362ec5a9-a269-4300-ae8f-f454252cf169
7663360851NDA AUTHORIZED GENERICDispensing Solutions, Inc.2009-08-26CALCITRIOLORALCAPSULE633040239NDA018044c64778c6-3be6-44f5-8387-ebcd82e3eae5
8680840475ANDAAmerican Health Packaging2012-03-012016-11-30CALCITRIOLORALCAPSULE000540007ANDA076917517f23e8-4ad5-46e7-8dc4-473d5dcb09c8
9681510088NDA AUTHORIZED GENERICCarilion Materials Management2009-08-26CALCITRIOLORALCAPSULE633040239NDA0180442d755a21-9f42-4d36-aaec-962495ab2f2b

calcitriol 0.0005 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930658ANDATeva Pharmaceuticals Usa Inc2001-10-15CALCITRIOLORALCAPSULE, LIQUID FILLEDANDA075765ae2d0165-1b19-4406-9f28-f4b1579c3dbf
2231550119ANDAHeritage Pharmaceuticals Inc.2013-05-29CALCITRIOLORALCAPSULE, LIQUID FILLEDANDA091174aaf62f0f-bd93-43f1-96f2-e4f001ea7328
3633040240NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2009-08-26CALCITRIOLORALCAPSULENDA01804466a69351-5b09-4368-a9fa-acf81b5ad882

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684582ANDAPhysicians Total Care, Inc.2010-03-01CALCITRIOLORALCAPSULE, LIQUID FILLED000930658ANDA07576584262b69-df29-41d0-9e97-6e1188096aeb
2551548281ANDACardinal Health2009-10-29CALCITRIOLORALCAPSULE, LIQUID FILLED000930658ANDA075765d3d69786-ac48-4a71-bbd8-83172e86d577
3604290134ANDAGolden State Medical Supply, Inc.2014-12-26CALCITRIOLORALCAPSULE, LIQUID FILLED231550119ANDA091174362ec5a9-a269-4300-ae8f-f454252cf169

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075765CALCITRIOLTEVA PHARMACEUTICALS USA INC2001-10-12ANDA075765_001, ANDA075765_002
2ANDA076917CALCITRIOLROXANE LABORATORIES INC2006-03-27ANDA076917_001
3ANDA091174CALCITRIOLBANNER LIFE SCIENCES LLC2013-05-24ANDA091174_001, ANDA091174_002
4ANDA091356CALCITRIOLSTRIDES PHARMA GLOBAL PTE LTD2014-12-12ANDA091356_001, ANDA091356_002
5NDA018044ROCALTROLVALIDUS PHARMACEUTICALS LLCNDA018044_001, NDA018044_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075765_001RXCALCITRIOL (0.25MCG)ORALCAPSULEFalseAB2001-10-12CALCITRIOL
2ANDA075765_002RXCALCITRIOL (0.5MCG)ORALCAPSULEFalseAB2001-10-12CALCITRIOL
3ANDA076917_001RXCALCITRIOL (0.25MCG)ORALCAPSULEFalseAB2006-03-27CALCITRIOL
4ANDA091174_001RXCALCITRIOL (0.25MCG)ORALCAPSULEFalseAB2013-05-24CALCITRIOL
5ANDA091174_002RXCALCITRIOL (0.5MCG)ORALCAPSULEFalseAB2013-05-24CALCITRIOL
6ANDA091356_001RXCALCITRIOL (0.25MCG)ORALCAPSULEFalseAB2014-12-12CALCITRIOL
7ANDA091356_002RXCALCITRIOL (0.5MCG)ORALCAPSULEFalseAB2014-12-12CALCITRIOL
8NDA018044_001RXCALCITRIOL (0.25MCG)ORALCAPSULEFalseABROCALTROL
9NDA018044_002RXCALCITRIOL (0.5MCG)ORALCAPSULETrueABROCALTROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1167a669f-7b7e-46ea-9331-567bf19d8787 (view SPL)CALCITRIOL CapsulesprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-03-272433530034
21b2aa7df-0f38-460e-b1f1-d7473be4ab3c (view SPL)ROCALTROL brand of (calcitrol) CAPSULES and ORAL SOLUTION Rx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2012-08-151433530633
32d755a21-9f42-4d36-aaec-962495ab2f2b (view SPL)CALCITRIOL CAPSULES and ORAL SOLUTION Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-08-312681510088
4362ec5a9-a269-4300-ae8f-f454252cf169 (view SPL)Calcitriol capsule, Liquid Filled Rx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-05-083604290133, 604290134
5517f23e8-4ad5-46e7-8dc4-473d5dcb09c8 (view SPL)CALCITRIOL CapsulesprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-014680840475
666a69351-5b09-4368-a9fa-acf81b5ad882 (view SPL)CALCITRIOL CAPSULES and ORAL SOLUTIONRx onlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2011-08-312633040239, 633040240, 633040241Calcitriol Oral Solution
784262b69-df29-41d0-9e97-6e1188096aeb (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-03-091548684582, 548684584
8aaf62f0f-bd93-43f1-96f2-e4f001ea7328 (view SPL)Calcitriol capsule, Liquid Filled Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2014-02-286231550118, 231550119
9ae2d0165-1b19-4406-9f28-f4b1579c3dbf (view SPL)CALCITRIOL CAPSULES, 0.25 mcg and 0.5 mcg06570658Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-01-305000930657, 000930658
10bebefb2a-7365-48e2-9681-83ed4b41e26e (view SPL)Calcitriol Capsules (0.25 mcg & 0.5 mcg)prescriptionHuman PrescriptionStrides Arcolab Limitedmanufacture2015-01-063643800723
11c64778c6-3be6-44f5-8387-ebcd82e3eae5 (view SPL)CALCITRIOL CAPSULES and ORAL SOLUTIONRx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-06-071663360851
12cdcaffc6-e14e-4607-b77b-fc78a8382f60 (view SPL)CALCITRIOL CapsulesprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-01-268000540007
13d1013494-bf62-4e68-9f0c-e6571137f20f (view SPL)ROCALTROL brand of (calcitrol) CAPSULES and ORAL SOLUTION Rx onlyprescriptionHuman PrescriptionValidus Pharmaceuticals Llcmanufacture2010-08-012306980143
14d3d69786-ac48-4a71-bbd8-83172e86d577 (view SPL)CALCITRIOL CAPSULES, 0.25 mcg and 0.5 mcg06570658Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2014-07-224551548251, 551548281
15e26e13c4-7e45-4e66-8c0d-7fc68e24cdd5 (view SPL)ROCALTROLbrand of(calcitriol)CAPSULES Rx OnlyprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-08-162001790069

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