Home NDC 69452-179 Naproxen Sodium
Product NDC 69452-179
11-digit product format 694520179
Labeler code 69452
Product ID 69452-179_0d85dc59-4954-47fc-e063-6394a90a01cd
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bionpharma Inc.
Application NDA021920
Marketing category NDA
Marketing start 2018-11-01
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 N021920-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL RLD, RS 2006-02-17
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021920-001 10022344 2026-03-03 U-1731 Drug product 2018-07-23 N021920-001 10022344 2026-03-03 U-1732 Drug product 2018-07-23 N021920-001 10028925 2026-03-03 U-1731 Drug product 2018-07-24 N021920-001 10028925 2026-03-03 U-1732 Drug product 2018-07-24 N021920-001 11090280 2026-03-03 U-1731 Drug product 2021-08-24 N021920-001 11090280 2026-03-03 U-1732 Drug product 2021-08-24 N021920-001 9693978 2026-03-03 Drug product 2017-11-13 N021920-001 9693979 2026-03-03 Drug product 2017-11-13
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 N021920-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL RLD, RS 2006-02-17 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N021920-001 10022344 2026-03-03 U-1731 Drug product 2018-07-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N021920-001 10022344 2026-03-03 U-1732 Drug product 2018-07-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N021920-001 10028925 2026-03-03 U-1731 Drug product 2018-07-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N021920-001 10028925 2026-03-03 U-1732 Drug product 2018-07-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N021920-001 11090280 2026-03-03 U-1731 Drug product 2021-08-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N021920-001 11090280 2026-03-03 U-1732 Drug product 2021-08-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N021920-001 9693978 2026-03-03 Drug product 2017-11-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N021920-001 9693979 2026-03-03 Drug product 2017-11-13 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 2 · 22 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base 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 1112231 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 69452-179-11 Naproxen Sodium 20 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 20 5 69452-179-15 Naproxen Sodium 40 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 40 5 69452-179-20 Naproxen Sodium 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 5 69452-179-22 Naproxen Sodium 120 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 120 5 69452-179-78 Naproxen Sodium 80 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 80 5 69452-179-79 Naproxen Sodium 160 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 160 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-179 NAPROXEN SODIUM CAPSULE, LIQUID FILLED [BIONPHARMA INC.] 5 Current NDC, Legacy NDC, 6 package rows 20231228_3e10256f-0a5f-49e4-9518-a72b10490f89.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 69452-179-11 69452017911 20 in 1 BOTTLE, PLASTIC Historical 69452-179-15 69452017915 40 in 1 BOTTLE, PLASTIC Historical 69452-179-20 69452017920 100 in 1 BOTTLE, PLASTIC Historical 69452-179-22 69452017922 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-179-22) 2018-11-01 0000-00-00 No No Current 69452-179-78 69452017978 80 in 1 BOTTLE, PLASTIC Historical 69452-179-79 69452017979 160 in 1 BOTTLE, PLASTIC Historical