hydrocodone bitartrate and acetaminophen

Product NDC: 46672-166
11-digit product format: 466720166
Labeler code: 46672
Product ID: 46672-166_acd89c6b-74e3-6782-e053-2995a90a1985
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone bitartrate and acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Mikart, LLC
Application: ANDA040658
Marketing category: ANDA
Marketing start: 2006-03-24
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 8 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;5MG	TABLET / ORAL	2006-01-19
A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;7.5MG	TABLET / ORAL	2006-03-24
A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;10MG	TABLET / ORAL	2004-06-23

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL			2006-01-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL			2006-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL			2004-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL			2006-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL			2006-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL			2004-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL			2006-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL			2006-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL			2004-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL			2006-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL			2006-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL			2004-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL			2006-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL			2006-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL			2004-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL			2006-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL			2006-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL			2004-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2006-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2006-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2004-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2006-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2006-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2004-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2006-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2006-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2004-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2006-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2006-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2004-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2006-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2006-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2004-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2006-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2006-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2004-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2006-01-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040658-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	RS	2006-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040658-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	RS	2004-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040658-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	RS	2006-01-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040658-003	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040658-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040658-002	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040658-003	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040658-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040658-002	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040658-003	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040658-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040658-002	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040658-003	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040658-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040658-002	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040658-003	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040658-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040658-002	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040658-003	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040658-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040658-002	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040658-003	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040658-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040658-002	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040658-003	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040658-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040658-002	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040658-003	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040658-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040658-002	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040658-003	AA	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [MIKART, INC.]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg/300 mg, 7.5 mg/300 mg 10 mg/300 mg	Mikart, LLC	2020-12-31	HUMAN PRESCRIPTION DRUG LABEL	12

hydrocodone bitartrate and acetaminophen

Orange Book products#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#