FDA.reportPublic FDA data

Application 089971

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL500MG;5MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE500MG;5MGTABLET / ORAL1988-12-02

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-023f01610625f2…
2019-09-15 20:21 UTC2019-09A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089971-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGTABLET / ORAL1988-12-02cb3db0bc1861…

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 8 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPc6210466-5feb-45d9-b637-b3f482bc3c2b2022-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP199d4915-cb3b-48f3-835d-a45d04a5c9402022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP50be5d00-758e-4d01-8e78-40a60dbe67e52021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPbab189ed-ff83-453c-a243-7ff052b2e4912021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.73dea6de-20cb-4cef-b987-3ab2c64e5edb2019-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.6e153073-ca78-481e-9e9c-0365ee3f3d592018-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-100Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenRebel Distributors CorpANDACurrent
66336-442Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenDispensing Solutions, Inc.ANDACurrent
67046-928Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenContract Pharmacy Services-PAANDACurrent
67296-0470HYDROCODONE BITARTRATE AND ACETAMINOPHENhydrocodone bitartrate and acetaminophenRedPharm Drug Inc.ANDACurrent
75921-881Hydrocodone Bitartrate And AcetaminophenHydrocodone Bitartrate And AcetaminophenLife Line Home Care Services, Inc.ANDACurrent