Hydrocodone Bitartrate and Acetaminophen

Product NDC: 64376-649
Requested package NDC: 64376-649-05
11-digit product format: 643760649
Labeler code: 64376
Product ID: 64376-649_a6b50936-c07e-426f-8b02-787c83792135
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA090415
Marketing category: ANDA
Marketing start: 2011-01-14
Marketing end: 2021-07-30
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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64376-649	64376-649-05	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;5MG	TABLET / ORAL	2011-01-24
A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;7.5MG	TABLET / ORAL	2011-01-24
A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;10MG	TABLET / ORAL	2011-01-24

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090415-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	2011-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090415-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090415-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	2011-01-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090415-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090415-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090415-003	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090415-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090415-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090415-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090415-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090415-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090415-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090415-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090415-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090415-003	AA	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64376-649-01	EA - Each	64376-649	9cbfb30c-805c-45d2-bf16-f634ffa6c541	1	2012-07-24
64376-649-05	EA - Each	64376-649	f40b1253-fa4b-4e9c-a35b-8af5b29d6e7b	1	2013-03-03

DailyMed Socrata Ingredients#

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64376-649-05	64376064905	500 TABLET in 1 BOTTLE (64376-649-05)	500 tablet	2011-01-14	2021-07-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc. \| Halo Pharmaceutical Inc \| Sovereign Pharmaceuticals, LLC	2019-08-15	HUMAN PRESCRIPTION DRUG LABEL	23