Oxycodone and Acetaminophen

Product NDC: 55700-498
Requested package NDC: 55700-498-56
11-digit product format: 557000498
Labeler code: 55700
Product ID: 55700-498_8c9196fe-65e3-4e1f-b71b-ae9e08d5a4e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products LLC
Application: ANDA201972
Marketing category: ANDA
Marketing start: 2016-12-01
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	55700-498	55700-498-56	D	Discontinued by firm		2026-08-03

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, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201972-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201972-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55700-498-01	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-05	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-10	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-14	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-15	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-20	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-21	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-24	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-28	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-30	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-40	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-56	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-60	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-90	2024-03-14	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-01	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-05	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-10	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-14	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-15	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-20	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-21	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-24	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-28	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-30	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-40	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-56	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-60	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-90	2024-01-30	Oxycodone and Acetaminophen Tablets, USP CII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-498-01	EA - Each	55700-498	a81c0ca7-9c4b-4685-af5d-725237ae5a5f	1	2017-03-06
55700-498-05	EA - Each	55700-498	6f85bbb2-6bd2-4ac6-9539-21471a87a053	1	2020-01-03
55700-498-10	EA - Each	55700-498	b23440ed-edaf-4d5d-a0b2-96539fb304a4	1	2019-07-02
55700-498-14	EA - Each	55700-498	65930224-e728-4548-a31a-316f314b8ed0	1	2017-05-04
55700-498-15	EA - Each	55700-498	9e30711b-368f-4e1b-ad7d-abdeaff64813	1	2017-03-06
55700-498-20	EA - Each	55700-498	9d9a0df1-3f24-403a-a6c3-1e8b3a8b8e14	1	2017-03-06
55700-498-21	EA - Each	55700-498	058da635-685f-4d59-a12f-f61846ce9a3b	1	2017-05-04
55700-498-24	EA - Each	55700-498	bb421720-89df-443d-8ef7-c9829e07b307	1	2020-08-06
55700-498-30	EA - Each	55700-498	28827b28-0266-4abb-a2b6-1087f475907c	1	2017-03-06
55700-498-40	EA - Each	55700-498	2e0511fc-181e-4596-9256-285e352e0c6e	1	2017-03-06
55700-498-60	EA - Each	55700-498	102cdfb3-a54b-4dbd-bb3a-253a49f7eff9	1	2017-03-06
55700-498-90	EA - Each	55700-498	da303743-cd40-4863-a27d-422da9c0c59d	1	2017-03-06

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 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

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
55700-498-56	55700049856	56 TABLET in 1 BOTTLE (55700-498-56)	56 tablet	2018-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen Tablets, USP CII	Quality Care Products LLC	2024-03-14	Human Prescription Drug Label	22