OXYCODONE/APAP

Product NDC: 61919-524
11-digit product format: 619190524
Labeler code: 61919
Product ID: 61919-524_86e366de-fa6b-89ae-e053-2a91aa0a2fed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE/APAP
Dosage form: TABLET
Route: ORAL
Labeler: DirectRX
Application: ANDA201972
Marketing category: ANDA
Marketing start: 2019-04-19
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-524		D	Discontinued by firm		2026-08-03
excluded package	package	61919-524	61919-524-90	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201972-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15
A201972-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2013-07-15
A201972-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15
A201972-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2013-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A201972-001	AA
A201972-002	AA
A201972-003	AA
A201972-004	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 · 144 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
2025-01-19 17:59 UTC	2025-01	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`5c6f7cd8ea54…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC	2025-01	A201972-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	A201972-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	A201972-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	A201972-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201972-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-004	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201972-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201972-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201972-003	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201972-004	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201972-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201972-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201972-003	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201972-004	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201972-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201972-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201972-003	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201972-004	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201972-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201972-002	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201972-003	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201972-004	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201972-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201972-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201972-003	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201972-004	AA	1	`5c6f7cd8ea54…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Aurolife Pharma, LLC	69df20d9-b1d5-47dc-9ff0-29987284f8c7	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	c12c26be-ba05-4d25-a2bf-f87623c6ae57	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	dd4dbe5b-8d07-4a96-a78d-2f20da761dad	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	df97ea5a-51df-453b-b1b4-edc74c718ee7	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-524-90	EA - Each	61919-524	51a2fc2d-7dae-4b28-a397-c90cb182fa9a	1	2019-08-06

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	Marketing end	Sample	Exclude flag	Status
61919-524-90	61919052490	90 TABLET in 1 BOTTLE (61919-524-90)	90 tablet	2019-04-19	0000-00-00	No	No	Current