Naproxen Sodium

Product NDC
63941-681
11-digit product format
639410681
Labeler code
63941
Product ID
63941-681_06d2daf1-3067-95e9-e063-6294a90aa789
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
NDA021920
Marketing category
NDA
Marketing start
2023-10-03
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

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui1112231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63941-681-16639410681161 BOTTLE, PLASTIC in 1 CARTON (63941-681-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2023-10-03NoNoHistorical