Oxycodone Hydrochloride and Acetaminophen

Product NDC: 60760-963
11-digit product format: 607600963
Labeler code: 60760
Product ID: 60760-963_53de0abf-2e30-c11a-e063-6394a90aa744
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA209385
Marketing category: ANDA
Marketing start: 2026-06-09
Substance: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 5; 325 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A209385-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2018-07-02
A209385-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02
A209385-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2018-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209385-001	AA
A209385-002	AA
A209385-003	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	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2018-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2018-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2018-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209385-002	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL		2018-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209385-003	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL		2018-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209385-001	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL		2018-07-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 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	A209385-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209385-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209385-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209385-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209385-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209385-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209385-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209385-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209385-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209385-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209385-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209385-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209385-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209385-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209385-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209385-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209385-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209385-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209385-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209385-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209385-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209385-003	AA	1	`d06236e962d9…`
2019-12-13 00:20 UTC	2019-12	A209385-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209385-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209385-003	AA	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A209385-001	AA	1	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Oxycodone Hydrochloride and Acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	5 mg/1
ACETAMINOPHEN	325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C1ENJ2TE6C	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
1049221	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
53de17b1-6d5b-c7c0-e063-6394a90a7064	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride and Acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	40a68a27-4422-5ba0-e063-6294a90ac550	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209385 application number: ANDA209385
Oxycodone Hydrochloride and Acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	40a882d6-a4db-1ad9-e063-6394a90a7268	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209385 application number: ANDA209385
Oxycodone Hydrochloride and Acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	53de17b1-6d5b-c7c0-e063-6394a90a7064	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209385 application number: ANDA209385 ndc (product): 60760-963
Oxycodone Hydrochloride and Acetaminophen	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	Elite Laboratories, Inc.	27fa8190-d334-4bb9-b277-d1f44db433e3	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209385 application number: ANDA209385

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-963-30	60760096330	30 TABLET in 1 BOTTLE, PLASTIC (60760-963-30)	30 tablet	2026-06-09	No	No	Current
60760-963-60	60760096360	60 TABLET in 1 BOTTLE, PLASTIC (60760-963-60)	60 tablet	2026-06-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen Tablets, USP CII	St. Mary's Medical Park Pharmacy	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	1