Home NDC 63981-368 kirkland signature naproxen sodium
Product NDC 63981-368
11-digit product format 639810368
Labeler code 63981
Product ID 63981-368_3e9d5f27-97d9-4c43-a27c-20636ab9b13d
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Costco Wholesale Company
Application ANDA074661
Marketing category ANDA
Marketing start 2007-06-04
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074661-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 3 · 56 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base kirkland signature naproxen sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN SODIUM 220 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9TN87S3A3C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849574 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63981-368-79 kirkland signature naproxen sodium 400 in 1 BOTTLE TABLET, FILM COATED 400 13 63981-368-91 kirkland signature naproxen sodium 1 in 1 PACKAGE TABLET, FILM COATED 1 13 63981-368-91 kirkland signature naproxen sodium 6 in 1 BOTTLE TABLET, FILM COATED 6 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63981-368 KIRKLAND SIGNATURE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 12 Current NDC, Legacy NDC, 3 package rows 20230621_d63cd2ad-18cf-4379-b48e-a487334ad9cc.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63981-368-79 63981036879 400 TABLET, FILM COATED in 1 BOTTLE (63981-368-79) 2007-06-04 0000-00-00 No No Current 63981-368-91 63981036891 1 BOTTLE in 1 PACKAGE (63981-368-91) > 6 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-02-03 0000-00-00 Yes No Current