Naproxen Sodium

Product NDC: 71335-2294
11-digit product format: 713352294
Labeler code: 71335
Product ID: 71335-2294_60bf4b42-31c4-4ebe-a925-18fc86daddb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA212199
Marketing category: ANDA
Marketing start: 2019-10-30
Substance: NAPROXEN SODIUM
Active strength: 550 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: 2027-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2294_60bf4b42-31c4-4ebe-a925-18fc86daddb4
SPL ID: 60bf4b42-31c4-4ebe-a925-18fc86daddb4
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Naproxen Sodium
Generic name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Marketing start: 2019-10-30
Marketing category: ANDA
Application number: ANDA212199
Pharmacologic classes: Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
Listing expiration: 2027-12-31

Ingredient	Strength
NAPROXEN SODIUM	550 mg/1

Package NDC	Description	Marketing start	Sample
71335-2294-1	500 TABLET in 1 BOTTLE (71335-2294-1)	2023-12-01	No

UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2294-1	71335229401	500 TABLET in 1 BOTTLE (71335-2294-1)	500 tablet	2023-12-01	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Naproxen Sodium	Bryant Ranch Prepack	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	101