Hydrocodone Bitartrate and Acetaminophen

Product NDC: 0904-6824
Requested package NDC: 0904-6824-61
11-digit product format: 009046824
Labeler code: 0904
Product ID: 0904-6824_0671ed02-4c4c-4403-b616-3dd8fbdd052b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA206245
Marketing category: ANDA
Marketing start: 2016-12-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 325 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0904-6824	0904-6824-61	D	Discontinued by firm		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 · 10 matching rows.

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

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	2016-12-01
A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	2016-12-01
A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	2016-12-01

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206245-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206245-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206245-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206245-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206245-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206245-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206245-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206245-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206245-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206245-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206245-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206245-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206245-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206245-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206245-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206245-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206245-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206245-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206245-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206245-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206245-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206245-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206245-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206245-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206245-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206245-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206245-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206245-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206245-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206245-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206245-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206245-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206245-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206245-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206245-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206245-003	AA	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206245-001	AA	1	`a72a2bbeb626…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6824-61	EA - Each	0904-6824	981eeec0-d269-4c92-9431-9d62b698a257	1	2019-09-05

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 Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Lupin Pharmaceuticals,Inc.	26a2178e-e0e5-4d61-81fd-e30a3142f1f2	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206245 application number: ANDA206245

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6824-61	00904682461	100 BLISTER PACK in 1 CARTON (0904-6824-61) > 1 TABLET in 1 BLISTER PACK	100 blister pack	2016-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only	Major Pharmaceuticals	2024-06-28	HUMAN PRESCRIPTION DRUG LABEL	4