Oxycodone and Acetaminophen

Product NDC: 35356-801
Requested package NDC: 35356-801-90
11-digit product format: 353560801
Labeler code: 35356
Product ID: 35356-801_f71642ee-fb46-43a0-aa5f-a7ceddb5a5a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA202677
Marketing category: ANDA
Marketing start: 2012-08-02
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
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	35356-801	35356-801-90	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202677-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26
A202677-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2012-07-26
A202677-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2016-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202677-001	AA
A202677-002	AA
A202677-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202677-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202677-003	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202677-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-07-26	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202677-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202677-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202677-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202677-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202677-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202677-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202677-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202677-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202677-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202677-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202677-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202677-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202677-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202677-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202677-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202677-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202677-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202677-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202677-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202677-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202677-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202677-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202677-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202677-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202677-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202677-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202677-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202677-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202677-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202677-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202677-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202677-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202677-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202677-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202677-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202677-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202677-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202677-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202677-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202677-001	AA	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-801-01	EA - Each	35356-801	95c3fd82-a297-4bf5-91ab-6f3fe2d93a65	1	2013-02-19
35356-801-30	EA - Each	35356-801	fd408a91-0e42-4c24-881d-0e4d66d8f6c9	1	2013-02-19
35356-801-60	EA - Each	35356-801	82396b50-bd97-4856-b041-cae0c675321a	1	2013-02-19
35356-801-90	EA - Each	35356-801	05676c1a-4d5c-46f9-b142-373cae8be646	1	2013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE AND ACETAMINOPHEN TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCT S LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35356-801	OXYCODONE AND ACETAMINOPHEN TABLET [QUALITY CARE PRODUCTS, LLC]	7	Legacy NDC	20241219_bbbc5dc1-5a91-4430-adcb-a5f6963cc0a2.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	3cd1cb17-4aea-a750-e063-6394a90a9594	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202677 application number: ANDA202677
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	3cf4c474-556e-5ebf-e063-6394a90acaf0	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202677 application number: ANDA202677
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Alvogen, Inc.	900ec197-720e-5428-b526-055b7756aa4a	2025-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202677 application number: ANDA202677
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	b4cf62af-b5d3-4825-9743-9ec3137164e8	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202677 application number: ANDA202677
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	223fe2b4-aa12-81fd-e063-6394a90a6c08	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202677 application number: ANDA202677
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	American Health Packaging	03c9ff0d-46e8-448c-944a-7ad59d1afd6d	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202677 application number: ANDA202677
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	0233de1c-466b-4842-8604-6d879aa36a4b	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202677 application number: ANDA202677

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35356-801-90	35356080190	90 TABLET in 1 BOTTLE (35356-801-90)	90 tablet	2013-09-10	0000-00-00	No	No	Current