FDA.reportPublic FDA data

Application 207172

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2017-06-22
A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2017-06-22
A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2017-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207172-001AA
A207172-002AA
A207172-003AA

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-2284e616aacf4f…
2026-08-18 06:07:402026-07A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207172-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORAL2017-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207172-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORAL2017-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207172-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORAL2017-06-22301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207172-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A207172-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A207172-003AA184e616aacf4f…
2026-08-18 06:07:402026-07A207172-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A207172-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A207172-003AA1caaa826d4ba7…
2019-09-15 20:21 UTC2019-09A207172-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207172-002AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207172-003AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207172-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207172-002AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207172-003AA1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207172-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207172-002AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207172-003AA1a50c72e98297…

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 7 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack42a74abc-bdc7-4ea3-a185-0293401117302024-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack82b7fd34-02ac-434a-be38-a1f0ec4f3e502024-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack9698729e-08d0-483c-b157-5a4061d970652024-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack6dde2f85-e329-4bca-832d-d45786df9f522024-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8b132cf3-c138-59ae-e053-2995a90a98a22024-08-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack6ad80616-b38d-4569-b24a-aa86e39feb662024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack025eb0f7-d002-4ce0-87b8-71461ab183562024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP9bad45b7-32ce-47aa-bfdf-8e6a755130562024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8c2a7a68-5a84-c909-e053-2995a90ad5b62024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8592e901-9353-6fb6-e053-2a91aa0ad33b2024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.86be8920-2f35-fbc3-e053-2991aa0a00152024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.c8d65aab-d6ae-bc69-e053-2a95a90a7b5e2024-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENLupin Pharmaceuticals,Inc.48cc1378-ffab-4645-95bb-a05d780665752024-02-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENLupin Pharmaceuticals,Inc.26a2178e-e0e5-4d61-81fd-e30a3142f1f22024-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.b9f61b9c-d3f9-47e3-94a3-b5228f96f9272023-09-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP62dd3c7a-4150-44a2-b05b-bc31308f22002023-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP82b24978-8b15-43a9-b5b0-3313ed2a73c22023-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPe6711f26-a01d-43e8-882a-d58561e4b67f2022-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.23dde6b8-3655-49ee-ac2c-28f80cf6b3c22022-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.5c00f98f-dcab-4bdb-901e-02eb873dea312022-05-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76100ORIG 2023-11-02
48830ORIG2017-06-26