Home NDC 43063-909 Naproxen Sodium
Product NDC 43063-909
11-digit product format 430630909
Labeler code 43063
Product ID 43063-909_302b48e9-e562-b7d7-e063-6394a90a3980
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA074661
Marketing category ANDA
Marketing start 2014-04-11
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 Naproxen Sodium
Listing expiration 2027-12-31 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 43063-909-20 Naproxen Sodium 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 10 43063-909-30 Naproxen Sodium 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-909 NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250315_c5146d73-2f34-4dfe-ac29-97071279dc4d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43063-909-20 43063090920 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-909-20) 2021-03-27 0000-00-00 No No Current 43063-909-30 43063090930 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-909-30) 2021-03-27 0000-00-00 No No Current