Methylprednisolone Oral Tablet

Brand(s)
Medrol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2013-11-21)
Oldest Current Product
1957-10-24
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\METHYLPREDNISOLONE
FDAOB
ORAL\TABLET\METHYLPREDNISOLONE
SPL Active
ORAL\TABLET\METHYLPREDNISOLONE
SPL Moiety
ORAL\TABLET\METHYLPREDNISOLONE

product(s) by strength(s)

methylprednisolone 16 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090073MedrolNDAPharmacia And Upjohn Company1957-10-24METHYLPREDNISOLONEORALTABLETNDA01115339d5270b-d957-4821-93d6-501b7b9f02d4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597460003ANDAJubilant Cadista Pharmaceuticals, Inc.1997-10-31METHYLPREDNISOLONEORALTABLETANDA0401897bf4d3d3-3f8a-4e20-9194-061658efca61
2597620050NDA AUTHORIZED GENERICGreenstone Llc2013-03-25METHYLPREDNISOLONEORALTABLETNDA01115322dd75d6-f89a-44f7-8ca6-b64c4e9806dd

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790124ANDAKaiser Foundations Hospitals2012-09-12METHYLPREDNISOLONEORALTABLET597460003ANDA040189e5369cef-689e-45bc-b530-405a05838fe5

methylprednisolone 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090020MedrolNDAPharmacia And Upjohn Company2013-09-20METHYLPREDNISOLONEORALTABLETNDA01115339d5270b-d957-4821-93d6-501b7b9f02d4

methylprednisolone 32 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090176MedrolNDAPharmacia And Upjohn Company1957-10-24METHYLPREDNISOLONEORALTABLETNDA01115339d5270b-d957-4821-93d6-501b7b9f02d4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597460015ANDAJubilant Cadista Pharmaceuticals, Inc.1997-10-31METHYLPREDNISOLONEORALTABLETANDA0401897bf4d3d3-3f8a-4e20-9194-061658efca61
2597620051NDA AUTHORIZED GENERICGreenstone Llc2013-03-25METHYLPREDNISOLONEORALTABLETNDA01115322dd75d6-f89a-44f7-8ca6-b64c4e9806dd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490564MedrolNDARemedyrepack Inc.2011-10-11METHYLPREDNISOLONEORALTABLET000090176NDA0111533a2e370b-f585-4489-a957-f5134019ef79

methylprednisolone 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090056MedrolNDAPharmacia And Upjohn Company1957-10-24METHYLPREDNISOLONEORALTABLETNDA01115339d5270b-d957-4821-93d6-501b7b9f02d4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006034593ANDAQualitest Pharmaceuticals1998-12-22METHYLPREDNISOLONEORALTABLETANDA040183c84cf5e6-746d-41fb-b3d8-2c0b8ba989af
2007815022ANDASandoz Inc1997-10-31METHYLPREDNISOLONEORALTABLETANDA04019497431ce3-85a9-41c3-817d-68963f9536cc
3519910188ANDABreckenridge Pharmaceutical, Inc.2003-11-07METHYLPREDNISOLONEORALTABLETANDA040189db9d0155-04d2-4759-a33b-f12f5826ad25
4597460001ANDAJubilant Cadista Pharmaceuticals, Inc.1997-10-31METHYLPREDNISOLONEORALTABLETANDA0401897bf4d3d3-3f8a-4e20-9194-061658efca61
5597624440NDA AUTHORIZED GENERICGreenstone Llc2011-10-11METHYLPREDNISOLONEORALTABLETNDA01115322dd75d6-f89a-44f7-8ca6-b64c4e9806dd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900879MedrolNDAStat Rx Usa Llc1957-10-24METHYLPREDNISOLONEORALTABLET000090056NDA0111534c0dd824-b099-47c3-aaf5-f6ddb873b3ee
2332610335ANDAAidarex Pharmaceuticals Llc1997-10-31METHYLPREDNISOLONEORALTABLET597460001ANDA040189ca9d4476-f81b-4a13-a343-88c43cbbcd34
3493490750ANDARemedyrepack Inc.2012-09-05METHYLPREDNISOLONEORALTABLET007815022ANDA040194eb490a04-fc21-42c8-a826-3cc8f67ebf6e
4493490884ANDARemedyrepack Inc.2012-03-01METHYLPREDNISOLONEORALTABLET519910188ANDA040189c7bc930b-05c1-4d3c-acfd-93edf0ba6cac
5493490957MedrolNDARemedyrepack Inc.2013-02-19METHYLPREDNISOLONEORALTABLET000090056NDA011153a82cafa3-f540-4c15-a2e0-faafe91d0820
6493490969ANDARemedyrepack Inc.2012-07-10METHYLPREDNISOLONEORALTABLET597460001ANDA04018932ca7128-ca03-4e79-9db5-f3e8b9201a79
7500900092MedrolNDAA-S Medication Solutions Llc1957-10-24METHYLPREDNISOLONEORALTABLET000090056NDA011153080a1789-f2d0-4d31-aa63-08cd703c7779
8548682913ANDAPhysicians Total Care, Inc.2009-10-15METHYLPREDNISOLONEORALTABLET005550301ANDA088497f27afd42-f81e-483a-ad1a-e0ea03c4f63e
9581180001ANDAClinical Solutions Wholesale1997-10-31METHYLPREDNISOLONEORALTABLET597460001ANDA040189996d21df-00b1-4444-814a-521b57e5e06d
10636293910ANDABryant Ranch Prepack1997-10-31METHYLPREDNISOLONEORALTABLET597460001ANDA040189473c90f1-9670-464a-ba13-da5f70415432
11680840149ANDAAmerican Health Packaging2013-11-25METHYLPREDNISOLONEORALTABLET006034593ANDA04018397256c7e-5694-4148-926f-594b9d5c34f4
12687884593ANDAPreferred Pharmaceuticals, Inc.2013-09-03METHYLPREDNISOLONEORALTABLET597460001ANDA040189ebe4f4a5-3fec-4f30-8289-25e594162c49
13687889218ANDAPreferred Pharmaceuticals, Inc.2014-10-08METHYLPREDNISOLONEORALTABLET006034593ANDA04018333d17918-0658-4783-8045-cdeb51dc0e08

methylprednisolone 8 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090022MedrolNDAPharmacia And Upjohn Company1957-10-24METHYLPREDNISOLONEORALTABLETNDA01115339d5270b-d957-4821-93d6-501b7b9f02d4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597460002ANDAJubilant Cadista Pharmaceuticals, Inc.1997-10-31METHYLPREDNISOLONEORALTABLETANDA0401897bf4d3d3-3f8a-4e20-9194-061658efca61
2597620049NDA AUTHORIZED GENERICGreenstone Llc2013-03-25METHYLPREDNISOLONEORALTABLETNDA01115322dd75d6-f89a-44f7-8ca6-b64c4e9806dd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040183METHYLPREDNISOLONEVINTAGE PHARMACEUTICALS INC1998-12-22ANDA040183_001
2ANDA040189METHYLPREDNISOLONEJUBILANT CADISTA PHARMACEUTICALS INC1997-10-31ANDA040189_001, ANDA040189_002, ANDA040189_003, ANDA040189_004
3ANDA040194METHYLPREDNISOLONESANDOZ INC1997-10-31ANDA040194_001
4ANDA040232METHYLPREDNISOLONEWATSON LABORATORIES INC1997-10-16ANDA040232_001
5ANDA085650METHYLPREDNISOLONETrueHEATHER DRUG CO INCANDA085650_001
6ANDA086159METHYLPREDNISOLONETrueWATSON LABORATORIES INC1982-02-09ANDA086159_001
7ANDA086161METHYLPREDNISOLONETrueWATSON LABORATORIES INC1982-02-09ANDA086161_001
8ANDA087341METHYLPREDNISOLONETrueSANDOZ INCANDA087341_001
9ANDA088497METHYLPREDNISOLONEDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1984-02-21ANDA088497_001
10ANDA089207METHYLPREDNISOLONETruePAR PHARMACEUTICAL INC1988-04-25ANDA089207_001
11ANDA089208METHYLPREDNISOLONETruePAR PHARMACEUTICAL INC1988-04-25ANDA089208_001
12ANDA089209METHYLPREDNISOLONETruePAR PHARMACEUTICAL INC1988-04-25ANDA089209_001
13NDA011153MEDROLPHARMACIA AND UPJOHN CONDA011153_001, NDA011153_002, NDA011153_003, NDA011153_004, NDA011153_005, NDA011153_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040183_001RXMETHYLPREDNISOLONE (4MG)ORALTABLETFalseAB1998-12-22METHYLPREDNISOLONE
2ANDA040189_001RXMETHYLPREDNISOLONE (4MG)ORALTABLETFalseAB1997-10-31METHYLPREDNISOLONE
3ANDA040189_002RXMETHYLPREDNISOLONE (8MG)ORALTABLETFalseAB1997-10-31METHYLPREDNISOLONE
4ANDA040189_003RXMETHYLPREDNISOLONE (16MG)ORALTABLETFalseAB2007-07-20METHYLPREDNISOLONE
5ANDA040189_004RXMETHYLPREDNISOLONE (32MG)ORALTABLETFalseAB2007-07-20METHYLPREDNISOLONE
6ANDA040194_001RXMETHYLPREDNISOLONE (4MG)ORALTABLETFalseAB1997-10-31METHYLPREDNISOLONE
7ANDA040232_001RXMETHYLPREDNISOLONE (4MG)ORALTABLETFalseAB1997-10-16METHYLPREDNISOLONE
8ANDA085650_001discontinuedMETHYLPREDNISOLONE (4MG)ORALTABLETFalseMETHYLPREDNISOLONE
9ANDA086159_001discontinuedMETHYLPREDNISOLONE (16MG)ORALTABLETFalse1982-02-09METHYLPREDNISOLONE
10ANDA086161_001discontinuedMETHYLPREDNISOLONE (4MG)ORALTABLETFalse1982-02-09METHYLPREDNISOLONE
11ANDA087341_001discontinuedMETHYLPREDNISOLONE (4MG)ORALTABLETFalseMETHYLPREDNISOLONE
12ANDA088497_001RXMETHYLPREDNISOLONE (4MG)ORALTABLETFalseAB1984-02-21METHYLPREDNISOLONE
13ANDA089207_001discontinuedMETHYLPREDNISOLONE (16MG)ORALTABLETFalse1988-04-25METHYLPREDNISOLONE
14ANDA089208_001discontinuedMETHYLPREDNISOLONE (24MG)ORALTABLETFalse1988-04-25METHYLPREDNISOLONE
15ANDA089209_001discontinuedMETHYLPREDNISOLONE (32MG)ORALTABLETFalse1988-04-25METHYLPREDNISOLONE
16NDA011153_001RXMETHYLPREDNISOLONE (4MG)ORALTABLETFalseABMEDROL
17NDA011153_002RXMETHYLPREDNISOLONE (2MG)ORALTABLETFalseABMEDROL
18NDA011153_003RXMETHYLPREDNISOLONE (16MG)ORALTABLETFalseABMEDROL
19NDA011153_004RXMETHYLPREDNISOLONE (8MG)ORALTABLETFalseABMEDROL
20NDA011153_005discontinuedMETHYLPREDNISOLONE (24MG)ORALTABLETFalseMEDROL
21NDA011153_006RXMETHYLPREDNISOLONE (32MG)ORALTABLETTrueABMEDROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1080a1789-f2d0-4d31-aa63-08cd703c7779 (view SPL)Medrol methylprednisolone tablets, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2015-02-151500900092
222dd75d6-f89a-44f7-8ca6-b64c4e9806dd (view SPL)Methylprednisolone Tablets, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-02-266597620049, 597620050, 597620051, 597624440
332ca7128-ca03-4e79-9db5-f3e8b9201a79 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-07-101493490969
433d17918-0658-4783-8045-cdeb51dc0e08 (view SPL)MethylPREDNISolone TABLETS, USP 4 mgprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-10-221687889218
539d5270b-d957-4821-93d6-501b7b9f02d4 (view SPL)Medrol methylprednisolone tablets, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2013-11-217000090020, 000090022, 000090056, 000090073, 000090176, 000090049
63a2e370b-f585-4489-a957-f5134019ef79 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-111493490564
7473c90f1-9670-464a-ba13-da5f70415432 (view SPL)METHYLPREDNISOLONE TABLETS, USP Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-02-131000636293910
84c0dd824-b099-47c3-aaf5-f6ddb873b3ee (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llc2010-04-012165900879
97bf4d3d3-3f8a-4e20-9194-061658efca61 (view SPL)METHYLPREDNISOLONE TABLETS, USP Rx onlyprescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.MANUFACTURE2011-03-312597460001, 597460002, 597460003, 597460015
1097256c7e-5694-4148-926f-594b9d5c34f4 (view SPL)MethylPREDNISolone TABLETS, USP 4 mgprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-162680840149
1197431ce3-85a9-41c3-817d-68963f9536cc (view SPL)MethylPREDNIsolone Tablets, USP 4 mgprescriptionHuman PrescriptionSandoz Inc2012-03-2614007815022
12996d21df-00b1-4444-814a-521b57e5e06d (view SPL)METHYLPREDNISOLONE TABLETS, USP Rx onlyprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-11-201581180001
13a82cafa3-f540-4c15-a2e0-faafe91d0820 (view SPL)Medrol methylprednisolone tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-195493490957
14c7bc930b-05c1-4d3c-acfd-93edf0ba6cac (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-011493490884
15c84cf5e6-746d-41fb-b3d8-2c0b8ba989af (view SPL)MethylPREDNISolone TABLETS, USP 4 mgprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2012-01-1611006034593
16ca9d4476-f81b-4a13-a343-88c43cbbcd34 (view SPL)METHYLPREDNISOLONE TABLETS, USP Rx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-131332610335
17db9d0155-04d2-4759-a33b-f12f5826ad25 (view SPL)METHYLPREDNISOLONE TABLETS, USPprescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2012-02-022519910188
18e5369cef-689e-45bc-b530-405a05838fe5 (view SPL)METHYLPREDNISOLONE TABLETS, USP Rx onlyprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2012-09-181001790124
19eb490a04-fc21-42c8-a826-3cc8f67ebf6e (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-09-051493490750
20ebe4f4a5-3fec-4f30-8289-25e594162c49 (view SPL)METHYLPREDNISOLONE TABLETS, USP Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-09-031687884593
21f27afd42-f81e-483a-ad1a-e0ea03c4f63e (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-10-262548682913

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