Home NDC 59651-528 Naproxen
Product NDC 59651-528
11-digit product format 596510528
Labeler code 59651
Product ID 59651-528_570974d4-0d5b-4df2-b307-37380511835d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216504
Marketing category ANDA
Marketing start 2025-10-03
Substance NAPROXEN
Active strength 125 mg/5mL
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 A216504-001 NAPROXEN NAPROXEN 25MG/ML SUSPENSION / ORAL 2025-10-03
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 2026-02-19 14:30 UTC 2026-02 A216504-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2025-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216504-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2025-10-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216504-001 NAPROXEN 25MG/ML SUSPENSION / ORAL 2025-10-03 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216504-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216504-001 AB 1 31067a03dcf5…
Additional Listing Data#
Finished product Yes
Brand name base Naproxen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN 125 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57Y76R9ATQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311913 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 59651-528-47 Naproxen 473 mL in 1 BOTTLE SUSPENSION 473 1 59651-528-47 Naproxen 1 in 1 CARTON SUSPENSION 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-528-47 59651052847 1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE 1 bottle 2025-10-03 No No Current