Naproxen Sodium

Product NDC: 43598-072
11-digit product format: 435980072
Labeler code: 43598
Product ID: 43598-072_c94f5885-67ab-4e95-df53-a58f119c504b
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Dr.Reddy's Laboratories Inc
Application: ANDA075168
Marketing category: ANDA
Marketing start: 2021-12-10
Substance: NAPROXEN SODIUM
Active strength: 220 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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 43598-072_c94f5885-67ab-4e95-df53-a58f119c504b
SPL ID: c94f5885-67ab-4e95-df53-a58f119c504b
Product type: HUMAN OTC DRUG
Finished product: Yes
Brand name base: Naproxen Sodium
Brand name suffix: Headache Pain
Generic name: Naproxen Sodium
Dosage form: TABLET, COATED
Route: ORAL
Marketing start: 2021-12-10
Marketing category: ANDA
Application number: ANDA075168
Pharmacologic classes: Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
NAPROXEN SODIUM	220 mg/1

Package NDC	Description	Marketing start	Sample
43598-072-01	1 BOTTLE in 1 CARTON (43598-072-01) / 100 TABLET, COATED in 1 BOTTLE	2021-12-10	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
43598-072-01	43598007201	1 BOTTLE in 1 CARTON (43598-072-01) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2021-12-10	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
NAPROXEN SODIUM TABLETS USP, 220 mg	Dr.Reddy's Laboratories Inc	2025-06-03	HUMAN OTC DRUG LABEL	6