Hydrocodone Bitartrate and Acetaminophen

Product NDC: 21695-268
11-digit product format: 216950268
Labeler code: 21695
Product ID: 21695-268_b935625d-e9e6-4b5b-a40a-3f4e7f01fa45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076642
Marketing category: ANDA
Marketing start: 2009-09-22
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-268		I	Inactivated by FDA	2026-10-05
excluded package	package	21695-268	21695-268-15	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-268	21695-268-28	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-268	21695-268-30	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-268	21695-268-60	I	Inactivated by FDA	2026-10-05

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 2 · 110 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	21695-268-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-268-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-268-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-268-28	`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	21695-268-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-268-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-268-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-268-28	`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	21695-268-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-268-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-268-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-268-28	`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	21695-268-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-268-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-268-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-268-28	`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	21695-268-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-268-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-268-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-268-28	`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	21695-268-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-268-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-268-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-268-28	`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	21695-268-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-268-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-268-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-268-28	`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	21695-268-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-268-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-268-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-268-28	`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	21695-268-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-268-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-268-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-268-28	`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	21695-268-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-268-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-268-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-268-28	`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	21695-268-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-268-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-268-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-268-28	`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	21695-268-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-268-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-268-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-268-28	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12
A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18
A076642-003	REPREXAIN	HYDROCODONE BITARTRATE; IBUPROFEN	2.5MG;200MG	TABLET / ORAL			2007-10-19
A076642-004	REPREXAIN	HYDROCODONE BITARTRATE; IBUPROFEN	10MG;200MG	TABLET / ORAL			2007-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076642-001	AB

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 5 · 172 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	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB		2004-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB		2004-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076642-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076642-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076642-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076642-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076642-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076642-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076642-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076642-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076642-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076642-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076642-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076642-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076642-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076642-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076642-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076642-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076642-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076642-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076642-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076642-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076642-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076642-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076642-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076642-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076642-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076642-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076642-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076642-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076642-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076642-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076642-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076642-001	AB	1	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
21695-268-15	2022-01-28	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-28	2022-01-28	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-30	2022-01-28	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-60	2022-01-28	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-15	2020-07-22	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-28	2020-07-22	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-30	2020-07-22	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-60	2020-07-22	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-15	2019-12-12	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-28	2019-12-12	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-30	2019-12-12	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-60	2019-12-12	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-15	2019-09-24	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-28	2019-09-24	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-30	2019-09-24	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
21695-268-60	2019-09-24	Hydrocodone Bitartrate and Acetaminophen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-268-15	Hydrocodone Bitartrate and Acetaminophen	15 in 1 BOTTLE	TABLET	15	1
21695-268-28	Hydrocodone Bitartrate and Acetaminophen	28 in 1 BOTTLE	TABLET	28	1
21695-268-30	Hydrocodone Bitartrate and Acetaminophen	30 in 1 BOTTLE	TABLET	30	1
21695-268-60	Hydrocodone Bitartrate and Acetaminophen	60 in 1 BOTTLE	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-268-15	EA - Each	21695-268	020e9ff1-25e1-49d2-98cd-80ba8408861b	1	2012-07-24
21695-268-28	EA - Each	21695-268	ae3813d2-2aef-4265-8569-691aa595c20d	1	2012-07-24
21695-268-30	EA - Each	21695-268	09f231d3-908d-4b35-86fd-5828fbf27595	1	2012-07-24
21695-268-60	EA - Each	21695-268	415f5240-becc-4f2e-97a3-a9c384de7e2f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-268	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 4 package rows	20101119_b935625d-e9e6-4b5b-a40a-3f4e7f01fa45.zip

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 Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Amneal Pharmaceuticals of New York LLC	abc33718-4e88-43ea-9ffa-2b04ffc812ef	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076642 application number: ANDA076642

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	b935625d-e9e6-4b5b-a40a-3f4e7f01fa45	1
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	b935625d-e9e6-4b5b-a40a-3f4e7f01fa45	1
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	b935625d-e9e6-4b5b-a40a-3f4e7f01fa45	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-268-15	21695026815	15 in 1 BOTTLE	Historical
21695-268-28	21695026828	28 in 1 BOTTLE	Historical
21695-268-30	21695026830	30 in 1 BOTTLE	Historical
21695-268-60	21695026860	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, USP	Rebel Distributors Corp	2010-09-30	HUMAN PRESCRIPTION DRUG LABEL	1