OXYCODONE AND ACETAMINOPHEN

Product NDC: 55700-983
11-digit product format: 557000983
Labeler code: 55700
Product ID: 55700-983_a85b6c73-1a88-461d-a3c8-6de272fe3fa4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone hydrochloride and acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA040545
Marketing category: ANDA
Marketing start: 2022-09-08
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-983-90	2025-01-16	C162847	48780-1	1030e364-f9d2-111a-e063-dadaa90a10e2	6eee72c5-9d15-4bab-9854-b0f62bfad091
55700-983-90	2024-01-30	C162847	48780-1	1030e364-f9d2-111a-e063-dadaa90a10e2	6eee72c5-9d15-4bab-9854-b0f62bfad091

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-983-90	EA - Each	55700-983	4b05b61d-39a0-4fb7-847c-a88a97e2e4cf	1	2022-10-06

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
55700-983-90	55700098390	90 TABLET in 1 BOTTLE (55700-983-90)	90 tablet	2022-09-08	0000-00-00	No	No	Current