Hydrocodone Bitartrate and Acetaminophen

Product NDC: 67296-1425
Requested package NDC: 67296-1425-2
11-digit product format: 672961425
Labeler code: 67296
Product ID: 67296-1425_bc2f912c-4a26-4b75-e053-2995a90a932b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA211487
Marketing category: ANDA
Marketing start: 2018-11-08
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-1425	67296-1425-2	I	Inactivated by FDA		2026-09-14

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 · 4 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
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07
A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	AA		2018-11-07
A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07
A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	AA		2018-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211487-001	AA
A211487-002	AA
A211487-003	AA
A211487-004	AA

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	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2018-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211487-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL		RS	2018-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211487-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA		2018-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211487-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA		2018-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211487-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2018-11-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 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	A211487-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211487-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211487-003	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211487-004	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211487-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211487-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211487-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211487-004	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211487-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211487-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211487-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211487-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211487-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211487-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211487-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211487-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211487-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211487-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211487-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211487-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211487-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211487-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211487-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211487-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211487-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211487-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211487-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211487-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211487-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211487-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211487-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211487-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211487-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211487-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211487-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211487-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211487-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211487-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211487-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211487-001	AA	1	`d8e5a09893c0…`

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
67296-1425-1	2024-08-07	Hydrocodone/Apap 10/325mg tab
67296-1425-2	2024-08-07	Hydrocodone/Apap 10/325mg tab
67296-1425-1	2023-01-30	Hydrocodone/Apap 10/325mg tab
67296-1425-2	2023-01-30	Hydrocodone/Apap 10/325mg tab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1425-1	Hydrocodone Bitartrate and Acetaminophen	10 in 1 BOTTLE	TABLET	10		2
67296-1425-2	Hydrocodone Bitartrate and Acetaminophen	20 in 1 BOTTLE	TABLET	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1425	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]	2	Legacy NDC, 2 package rows	20240808_bc2f912c-4a25-4b75-e053-2995a90a932b.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 · 17 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	Bryant Ranch Prepack	c4dc75b4-8016-4875-a859-6346c48cc0e7	2025-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	39b8382a-e96d-462d-895f-27cbb9a305ec	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	ac88fa99-625b-4854-a406-9e21a6b9c1c8	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	ee4b164d-7ee2-4c19-b1a3-cb60c6676786	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	94ba2279-440e-4eaf-ad19-04d90a5c4c10	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	177c4cd8-80dd-4ed7-9e12-dcec70e0278e	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	96a84a12-da15-410a-9c70-af125f2fcacc	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	5d5fa7bb-6416-48dc-95a0-43ffd84cb595	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	72244b9c-eac4-41c2-8ba6-7302eafba90a	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Camber Pharmaceuticals, Inc.	4d5bfd3a-3793-4d24-aedd-c04fa34ea736	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Camber Pharmaceuticals, Inc.	ed6af366-753c-4f3b-a6a2-c9a183c50035	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Direct Rx	db73b8ed-9747-6a49-e053-2a95a90a93a1	2025-02-21	Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	DirectRx	dd934235-3b2a-51ca-e053-2995a90a0016	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone APAP	HYDROCODONE APAP	Direct_Rx	deaa53c1-81ed-7497-e053-2995a90a07cc	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	XLCare Pharmaceuticals, Inc.	b9f61b9c-d3f9-47e3-94a3-b5228f96f927	2023-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Proficient Rx LP	c6210466-5feb-45d9-b637-b3f482bc3c2b	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	XLCare Pharmaceuticals, Inc.	73dea6de-20cb-4cef-b987-3ab2c64e5edb	2019-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211487 application number: ANDA211487

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
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	bc2f912c-4a25-4b75-e053-2995a90a932b	2
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	bc2f912c-4a25-4b75-e053-2995a90a932b	2
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	bc2f912c-4a25-4b75-e053-2995a90a932b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1425-2	67296142502	20 TABLET in 1 BOTTLE (67296-1425-2)	20 tablet	2018-11-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone/Apap 10/325mg tab	RedPharm Drug, Inc. \| RedPharm	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	2