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 4 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENPAI Holdings, LLC dba PAI Pharmac29b97e9-8097-4d87-a420-ccf5aec8274a2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack88c031ee-3d3d-4e8a-b69b-d18db612a9f32026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAvPAK678f3d54-3b62-c9e8-2ff3-a2a6bd9ecfc32026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC93b6dfdf-ba6e-4ea6-ab85-5ac121e331012026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: hydrocodone bitartrate and acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLC57e1fe79-eb60-4f4f-bb38-6df0270d408f2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLCd8fe4ae4-bd19-42eb-b74d-f302b3f914ee2025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLCd4caec6d-4af2-4f1c-9add-c0c948b83b162025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC392a846e-7325-462d-b19b-8afda44c5cb02025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRedpharm Drug37451478-b961-873b-e063-6394a90a7b4e2025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC60f43308-1deb-4f05-8f17-aa49ebdcf4982025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAmerican Health Packagingf55d0cc9-996e-49c2-b8c1-acaceac99afe2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.d1de0f93-1439-4ee3-b692-56e1a14006822025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLCe0cefc7b-e81c-4e15-89a0-fe71dc94338b2025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENGranules Pharmaceuticals Inc.136bbd47-7a54-493f-9158-a84d39221d6c2025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc4dc75b4-8016-4875-a859-6346c48cc0e72025-10-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack36bf5e37-9202-4288-8354-9d123fb692d32025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENElite Laboratories, Inc.89b8145f-5310-4b58-a65d-586dc90d642d2025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEpic Pharma, LLC5179d4ab-6d57-4613-84fc-de3f6edd6a532025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAmneal Pharmaceuticals LLCe23d135c-7aea-405a-804e-5c4f82179e962025-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack39b8382a-e96d-462d-895f-27cbb9a305ec2025-10-22Boxed 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