Naproxen

Product NDC: 68071-2769
11-digit product format: 680712769
Labeler code: 68071
Product ID: 68071-2769_e20d5c15-7941-1c16-e053-2995a90acc2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA212517
Marketing category: ANDA
Marketing start: 2020-03-01
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 250 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2769-3	2025-01-30	C162847	48780-1	2cef2736-8570-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2769-3	Naproxen	30 in 1 BOTTLE	TABLET	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2769	NAPROXEN TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220624_e20d5c0c-dcd8-e0d5-e053-2995a90aaf4d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198013	naproxen 250 MG Oral Tablet	PSN	e20d5c0c-dcd8-e0d5-e053-2995a90aaf4d	1
198013	naproxen 250 MG Oral Tablet	SCD	e20d5c0c-dcd8-e0d5-e053-2995a90aaf4d	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2769-3	68071276903	30 TABLET in 1 BOTTLE (68071-2769-3)	30 tablet	2022-06-22	0000-00-00	No	No	Current