Hydrocodone Bitartrate and Acetaminophen

Product NDC: 0527-1647
11-digit product format: 005271647
Labeler code: 0527
Product ID: 0527-1647_bfc6e882-7608-4572-8651-c47523e7acef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA207171
Marketing category: ANDA
Marketing start: 2017-06-20
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 300 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0527-1647		D	Discontinued by firm	2026-10-05
excluded package	package	0527-1647	0527-1647-01	D	Discontinued by firm	2026-10-05
excluded package	package	0527-1647	0527-1647-05	D	Discontinued by firm	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 1 · 27 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	0527-1647-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1647-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1647-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1647-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1647-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1647-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1647-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1647-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1647-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1647-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1647-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1647-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1647-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1647-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1647-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1647-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1647-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1647-05	`0efc9e666f02…`	`f202fb6c5f17…`

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	TE codes	Approval date
A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;5MG	TABLET / ORAL	AA	2017-06-20
A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;7.5MG	TABLET / ORAL	AA	2017-06-20
A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;10MG	TABLET / ORAL	AA	2017-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207171-001	AA
A207171-002	AA
A207171-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2017-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	2017-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	2017-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2017-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	2017-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	2017-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207171-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL		2017-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207171-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL		2017-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207171-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL		2017-06-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207171-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207171-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207171-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207171-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207171-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207171-003	AA	1	`caaa826d4ba7…`
2019-09-15 20:21 UTC	2019-09	A207171-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207171-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207171-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207171-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207171-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207171-003	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207171-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207171-002	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207171-003	AA	1	`a50c72e98297…`

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
0527-1647-01	EA - Each	0527-1647	5cf01372-6e8c-41f0-a47e-997e98125c58	1	2018-10-11
0527-1647-05	EA - Each	0527-1647	0daef86a-9ddf-4a5c-b5cc-f4c8f78edf07	1	2018-10-11

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
0527-1647-01	00527164701	100 TABLET in 1 BOTTLE (0527-1647-01)	100 tablet	2017-06-20	0000-00-00	No	No	Current
0527-1647-05	00527164705	500 TABLET in 1 BOTTLE (0527-1647-05)	500 tablet	2017-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: January 2024	Lannett Company, Inc.	2024-01-18	HUMAN PRESCRIPTION DRUG LABEL	28