Naproxen

Product NDC: 70934-803
11-digit product format: 709340803
Labeler code: 70934
Product ID: 70934-803_bb79a9f5-e6b9-b7af-e053-2995a90a314b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application: ANDA212517
Marketing category: ANDA
Marketing start: 2020-11-03
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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
70934-803-20	2023-01-30	C162847	48780-1	f386c64a-35b4-0266-e053-dadaa90a7c1a	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
70934-803-30	2023-01-30	C162847	48780-1	f386c64a-35b4-0266-e053-dadaa90a7c1a	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
70934-803-20	Naproxen	20 in 1 BOTTLE, PLASTIC	TABLET	20		2
70934-803-30	Naproxen	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-803	NAPROXEN TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20210804_b5589d2a-dfea-c6c1-e053-2995a90aca1c.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
198014	naproxen 500 MG Oral Tablet	PSN	b5589d2a-dfea-c6c1-e053-2995a90aca1c	2
198014	naproxen 500 MG Oral Tablet	SCD	b5589d2a-dfea-c6c1-e053-2995a90aca1c	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-803-20	70934080320	20 TABLET in 1 BOTTLE, PLASTIC (70934-803-20)	20 tablet	2020-11-03	0000-00-00	No	No	Current
70934-803-30	70934080330	30 TABLET in 1 BOTTLE, PLASTIC (70934-803-30)	30 tablet	2021-02-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	2