Application 040881

Type: ANDA
Sponsor: MIKART

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SOLUTION;ORAL	300MG/15ML;10MG/15ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	RS	2010-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	RS	2010-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	RS	2010-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040881-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		RS	2010-02-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A040881-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040881-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040881-001	AA	1	`bb7c543d1eb4…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Hikma Pharmaceuticals USA Inc.	995a6cc7-8b72-4d35-b3b4-8c5752438fb7	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040881 application number: ANDA040881

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-450	Lortab	Hydrocodone Bitartrate and Acetaminophen	Akorn, Inc.	ANDA	Current
17478-450	Lortab	Hydrocodone Bitartrate and Acetaminophen	Akorn, Inc.	ANDA	Current
17478-450	Lortab	Hydrocodone Bitartrate and Acetaminophen	Akorn, Inc.	ANDA	Current
17478-450	Lortab	Hydrocodone Bitartrate and Acetaminophen	Akorn	ANDA	Current
17478-450	Lortab	Hydrocodone Bitartrate and Acetaminophen	Akorn	ANDA	Current
17856-0450	Lortab	Hydrocodone Bitartrate and Acetaminophen	Atlantic Biologicals Corps	ANDA	Current
46672-645	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Mikart, LLC	ANDA	Current
46672-645	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Mikart, LLC	ANDA	Current
46672-645	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Mikart, LLC	ANDA	Current
46672-645	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Mikart, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76118	ORIG	2023-11-03