Hydrocodone Bitartrate and Acetaminophen

Product NDC: 71335-1419
11-digit product format: 713351419
Labeler code: 71335
Product ID: 71335-1419_a06e3609-11cb-4bf3-a214-fdfedfbe5e3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202991
Marketing category: ANDA
Marketing start: 2016-04-12
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 325; 7.5 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-1419		D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-0	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-1	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-2	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-3	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-4	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-5	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-6	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-7	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-8	D	Discontinued by firm	2026-08-10
excluded package	package	71335-1419	71335-1419-9	D	Discontinued by firm	2026-08-10

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 3 · 132 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	71335-1419-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1419-3	`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	71335-1419-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1419-3	`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	71335-1419-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1419-3	`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	71335-1419-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1419-3	`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	71335-1419-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1419-3	`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	71335-1419-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1419-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1419-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1419-8	`cdf11ea48f46…`	`ba0047e9e063…`

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	TE codes	Approval date
A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	AA	2016-04-12
A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12
A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	AA	2016-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202991-001	AA
A202991-002	AA
A202991-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202991-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202991-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202991-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202991-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202991-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202991-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202991-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202991-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202991-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202991-001	AA	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocodone Bitartrate and Acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	325 mg/1
ACETAMINOPHEN	7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NO70W886KK	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857005	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ad0df84-e3f6-4c1d-b791-c8467eb984aa	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1419-0	Hydrocodone Bitartrate and Acetaminophen	8 in 1 BOTTLE	TABLET	8	104
71335-1419-1	Hydrocodone Bitartrate and Acetaminophen	120 in 1 BOTTLE	TABLET	120	104
71335-1419-2	Hydrocodone Bitartrate and Acetaminophen	15 in 1 BOTTLE	TABLET	15	104
71335-1419-3	Hydrocodone Bitartrate and Acetaminophen	20 in 1 BOTTLE	TABLET	20	104
71335-1419-4	Hydrocodone Bitartrate and Acetaminophen	28 in 1 BOTTLE	TABLET	28	104
71335-1419-5	Hydrocodone Bitartrate and Acetaminophen	30 in 1 BOTTLE	TABLET	30	104
71335-1419-6	Hydrocodone Bitartrate and Acetaminophen	40 in 1 BOTTLE	TABLET	40	104
71335-1419-7	Hydrocodone Bitartrate and Acetaminophen	56 in 1 BOTTLE	TABLET	56	104
71335-1419-8	Hydrocodone Bitartrate and Acetaminophen	60 in 1 BOTTLE	TABLET	60	104
71335-1419-9	Hydrocodone Bitartrate and Acetaminophen	90 in 1 BOTTLE	TABLET	90	104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1419-8	EA - Each	71335-1419	625e22e3-9007-408c-a0c4-fc71bc6e3394	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1419	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 10 package rows	20240828_8ad0df84-e3f6-4c1d-b791-c8467eb984aa.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 · 19 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	8ad0df84-e3f6-4c1d-b791-c8467eb984aa	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 71335-1419
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	418ea599-55e0-4d57-a4b1-16568e30f6f7	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	25d49886-9f9a-4015-bca2-9190b30d9120	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	e83d90f9-513b-47c2-ae2a-748ce775ef5d	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	380ff458-d5d7-422e-ac96-e9a56ade16b6	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Rhodes Pharmaceuticals LLC	1f9c1adc-f84f-43de-af5c-d93703aba7f8	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	44687e20-a1c4-4cf3-b2ac-4d489d54b740	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	3d431951-eb0f-45ac-a6ba-d99929bdcaaf	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	878c004c-1e92-4400-95f5-e79cf9ba6844	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	a8b9e9fe-e1a5-4a77-9a1f-d30eb622168c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	0cc8836b-f0af-42e0-bd77-53fd1dd1aca7	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	3bd8e7b1-e31c-4298-ba1e-eaf2a0954208	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	a2e33ea3-941f-4810-b008-abbb109730a9	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	29491adb-d95d-4f68-ac01-61bad73e08fc	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Asclemed USA, Inc.	d1de0f93-1439-4ee3-b692-56e1a1400682	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	82b7fd34-02ac-434a-be38-a1f0ec4f3e50	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	025eb0f7-d002-4ce0-87b8-71461ab18356	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Asclemed USA, Inc.	23dde6b8-3655-49ee-ac2c-28f80cf6b3c2	2022-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Asclemed USA, Inc.	5c00f98f-dcab-4bdb-901e-02eb873dea31	2022-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	8ad0df84-e3f6-4c1d-b791-c8467eb984aa	104
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	8ad0df84-e3f6-4c1d-b791-c8467eb984aa	104
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	8ad0df84-e3f6-4c1d-b791-c8467eb984aa	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1419-0	71335141900	8 TABLET in 1 BOTTLE (71335-1419-0)	8 tablet	2020-05-12	0000-00-00	No	No	Current
71335-1419-1	71335141901	120 TABLET in 1 BOTTLE (71335-1419-1)	120 tablet	2020-03-31	0000-00-00	No	No	Current
71335-1419-2	71335141902	15 TABLET in 1 BOTTLE (71335-1419-2)	15 tablet	2020-07-06	0000-00-00	No	No	Current
71335-1419-3	71335141903	20 TABLET in 1 BOTTLE (71335-1419-3)	20 tablet	2020-03-06	0000-00-00	No	No	Current
71335-1419-4	71335141904	28 TABLET in 1 BOTTLE (71335-1419-4)	28 tablet	2024-07-09	0000-00-00	No	No	Current
71335-1419-5	71335141905	30 TABLET in 1 BOTTLE (71335-1419-5)	30 tablet	2020-02-20	0000-00-00	No	No	Current
71335-1419-6	71335141906	40 TABLET in 1 BOTTLE (71335-1419-6)	40 tablet	2024-07-09	0000-00-00	No	No	Current
71335-1419-7	71335141907	56 TABLET in 1 BOTTLE (71335-1419-7)	56 tablet	2024-07-09	0000-00-00	No	No	Current
71335-1419-8	71335141908	60 TABLET in 1 BOTTLE (71335-1419-8)	60 tablet	2019-12-13	0000-00-00	No	No	Current
71335-1419-9	71335141909	90 TABLET in 1 BOTTLE (71335-1419-9)	90 tablet	2020-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg	Bryant Ranch Prepack	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	105