Application 040256

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL5MGNoNo
002PREDNISONEPREDNISONETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040256-001PREDNISONEPREDNISONE5MGTABLET / ORALAB2002-07-12
A040256-002PREDNISONEPREDNISONE10MGTABLET / ORALAB2002-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040256-001AB
A040256-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040256-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040256-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040256-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040256-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040256-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040256-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040256-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040256-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040256-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040256-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040256-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040256-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040256-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040256-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040256-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040256-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040256-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040256-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040256-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040256-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040256-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040256-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040256-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040256-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040256-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040256-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040256-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040256-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040256-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A040256-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040256-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A040256-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040256-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040256-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040256-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040256-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040256-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A040256-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040256-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040256-002AB1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEBryant Ranch Prepack931171e2-0bdb-451e-b737-72ce3ffbed532026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEBryant Ranch Prepack55aedced-d945-4bd2-9aa8-0f18b89a0e7f2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 63629-2257
PrednisonePREDNISONEBryant Ranch Prepackdc3bbb97-6588-46f4-b0ad-47596874ad0c2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 63629-2261
PrednisonePREDNISONEBryant Ranch Prepack290a91e5-22ae-4d62-ab34-39a3117002e22026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 63629-1605
PrednisonePREDNISONEREMEDYREPACK INC.746b0bcd-122e-4ea8-a824-28415073a38e2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEMajor Pharmaceuticals57b98930-92ab-4b77-a033-ae9895ee718a2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 0904-6923
PrednisonePREDNISONEPar Health USA, LLC10fe5a3b-84dc-4600-87c2-b80c97ce18cf2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 0603-5338
ndc (product): 0603-5337
PrednisonePREDNISONEA-S Medication Solutionsb5b088b9-8f90-468f-b7a4-a5274aa0aec92026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 50090-1001
PrednisonePREDNISONEA-S Medication Solutions71295010-5adb-499b-a03a-5c78b5e79b2d2026-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 50090-0439
PrednisonePREDNISONECardinal Health 107, LLC199ed6a6-d9d9-49de-b383-5933a026591b2026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutionsefe0c82b-9dd9-4729-b06f-06307867aca02026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEAmerican Health Packaginga0e8d1a2-8c82-4dc0-8c2f-9da84382f34e2025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 60687-122
ndc (product): 60687-134
PrednisonePREDNISONECardinal Health 107, LLC568b8880-7997-4786-8c57-28816ce526552025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 55154-3564
PrednisonePREDNISONEPreferred Pharmaceuticals, Inc.f89bd1dc-88cd-4aef-a7ae-6310f38a34232025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions95cf05e5-1446-43f5-8447-c04877a747812024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions410988ea-456a-454e-932c-fcbdbef04ba92024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions44069d49-4cf4-4f1e-9fbd-b496c6ca81a12024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEProficient Rx LP7d52bf53-76e3-4826-a12b-b16a8560bafc2021-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 63187-066
ndc (product): 63187-037
PrednisonePREDNISONEAphena Pharma Solutions - Tennessee, LLCb902ed21-c776-4046-8fbc-9ce95b16b1392017-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 118 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-5337PrednisonePrednisonePar Pharmaceutical, Inc.ANDACurrent
0603-5337PrednisonePrednisonePar PharmaceuticalANDACurrent
0603-5337PrednisonePrednisonePar PharmaceuticalANDACurrent
0603-5337PrednisonePrednisonePar PharmaceuticalANDACurrent
0603-5337PrednisonePrednisonePar PharmaceuticalANDACurrent
0603-5338PrednisonePrednisonePar Pharmaceutical, Inc.ANDACurrent
0603-5338PrednisonePrednisonePar PharmaceuticalANDACurrent
0603-5338PrednisonePrednisonePar PharmaceuticalANDACurrent
0603-5338PrednisonePrednisonePar PharmaceuticalANDACurrent
0603-5338PrednisonePrednisonePar PharmaceuticalANDACurrent
0904-6923PrednisonePrednisoneMajor PharmaceuticalsANDACurrent
0904-6923PrednisonePrednisoneMajor PharmaceuticalsANDACurrent
0904-6923PrednisonePrednisoneMajor PharmaceuticalsANDACurrent
21695-764PrednisoneprednisoneRebel Distributors CorpANDACurrent
21695-765PrednisoneprednisoneRebel Distributors CorpANDACurrent
33261-351PrednisonePrednisoneAidarex Pharmaceuticals LLCANDACurrent
33261-352PrednisonePrednisoneAidarex Pharmaceuticals LLCANDACurrent
33261-780PrednisonePrednisoneAidarex Pharmaceuticals LLCANDACurrent
43063-426PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-638PrednisonePrednisoneMedsource PharmaceuticalsANDACurrent
45865-638PrednisonePrednisoneMedsource PharmaceuticalsANDACurrent
45865-670PrednisonePrednisoneMedsource PharmaceuticalsANDACurrent
45865-670PrednisonePrednisoneMedsource PharmaceuticalsANDACurrent
49999-028PrednisonePrednisoneLake Erie medical DBA Quality Care Products LLCANDACurrent
49999-028PrednisonePrednisoneLake Erie medical DBA Quality Care Products LLCANDACurrent
49999-028PrednisonePrednisoneLake Erie medical DBA Quality Care Products LLCANDACurrent
50090-0097PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-0097PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-0098PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-0098PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-0439PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-0439PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-1001PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-1001PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-1001PrednisonePrednisoneA-S Medication SolutionsANDACurrent
50090-2403PrednisonePrednisoneA-S Medication SolutionsANDACurrent
52959-126PrednisonePrednisoneH.J. Harkins Company, Inc.ANDACurrent
52959-220PrednisonePrednisoneH.J. Harkins Company, Inc.ANDACurrent
52959-220PREDNISONEPREDNISONEH. J. Harkins Company Inc.ANDACurrent
53002-0610PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-0610PrednisonePrednisoneRPK Pharmaceuticals, Inc.ANDACurrent
53808-0542PrednisonePREDNISONEState of Florida DOH Central PharmacyANDACurrent
53808-0560PrednisonePREDNISONEState of Florida DOH Central PharmacyANDACurrent
55154-3564PrednisonePrednisoneCardinal Health 107, LLCANDACurrent
55289-373PrednisonePrednisonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55695-014PrednisonePrednisoneDepartment of State Health Services, Pharmacy BranchANDACurrent
55695-024PrednisonePrednisoneDepartment of State Health Services, Pharmacy BranchANDACurrent
55700-049PrednisonePrednisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-122PrednisonePrednisoneAmerican Health PackagingANDACurrent
60687-122PrednisonePrednisoneAmerican Health PackagingANDACurrent
60687-122PrednisonePrednisoneAmerican Health PackagingANDACurrent
60687-134PrednisonePrednisoneAmerican Health PackagingANDACurrent
60687-134PrednisonePrednisoneAmerican Health PackagingANDACurrent
60687-134PrednisonePrednisoneAmerican Health PackagingANDACurrent
63187-037PrednisonePrednisoneProficient Rx LPANDACurrent
63187-037PrednisonePrednisoneProficient Rx LPANDACurrent
63187-037PrednisonePrednisoneProficient Rx LPANDACurrent
63187-066PrednisonePrednisoneProficient Rx LPANDACurrent
63187-066PrednisonePrednisoneProficient Rx LPANDACurrent
63187-066PrednisonePrednisoneProficient Rx LPANDACurrent
63629-1579PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-1579PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-1605PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-1605PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2256PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2256PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2256PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2257PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2257PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2258PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2258PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2259PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2259PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2261PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2261PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2261PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2262PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2262PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2262PrednisonePrednisoneBryant Ranch PrepackANDACurrent
63629-2263PrednisonePrednisoneBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29902ORIG2003-04-08