Hydrocodone Bitartrate and Acetaminophen

Product NDC: 0591-2172
11-digit product format: 005912172
Labeler code: 0591
Product ID: 0591-2172_1e4c7b2c-26c4-4ab7-a586-42809be22140
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA040148
Marketing category: ANDA
Marketing start: 2016-05-26
Marketing end: 2019-12-31
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 5 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0591-2172		D	Discontinued by firm	2026-08-17
excluded package	package	0591-2172	0591-2172-01	D	Discontinued by firm	2026-08-17
excluded package	package	0591-2172	0591-2172-05	D	Discontinued by firm	2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-2172-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-2172-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-2172-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-2172-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-2172-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-2172-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-2172-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-2172-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-2172-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-2172-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-2172-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-2172-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-2172-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-2172-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-2172-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-2172-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-2172-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-2172-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-2172-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-2172-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-2172-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-2172-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-2172-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-2172-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040148-001	NORCO	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	1997-02-14
A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG;10MG	TABLET / ORAL	1997-02-14
A040148-003	NORCO	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	2000-09-12
A040148-004	NORCO	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;2.5MG	TABLET / ORAL	2014-07-07
A040148-005	NORCO	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	2014-07-07

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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`2680178bc6a6…`

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	A040148-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040148-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040148-004	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040148-005	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040148-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040148-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040148-004	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040148-005	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040148-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040148-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040148-004	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040148-005	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040148-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040148-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040148-004	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040148-005	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040148-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040148-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040148-004	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040148-005	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040148-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040148-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040148-004	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040148-005	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040148-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040148-003	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040148-004	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040148-005	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040148-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040148-003	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040148-004	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040148-005	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
0591-2172-01	EA - Each	0591-2172	ea1bc4aa-990b-4e18-85c8-401de89ca493	1	2016-09-02
0591-2172-05	EA - Each	0591-2172	7b452cd4-acba-448a-a7f2-1ce9ff9a549f	1	2016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ACTAVIS PHARMA, INC.]	8
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ACTAVIS PHARMA, INC.]	8
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ACTAVIS PHARMA, INC.]	8
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ACTAVIS PHARMA, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ACTAVIS PHARMA, INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ACTAVIS PHARMA, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ACTAVIS PHARMA, INC.]	8

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 USP	Major Pharmaceuticals	2019-12-10	HUMAN PRESCRIPTION DRUG LABEL	5
Hydrocodone Bitartrate and Acetaminophen Tablets USP	Actavis Pharma, Inc.	2019-05-29	HUMAN PRESCRIPTION DRUG LABEL	19