Home NDC 62207-762 Naproxen Sodium
Product NDC 62207-762
11-digit product format 622070762
Labeler code 62207
Product ID 62207-762_f4026a0a-c9cd-3850-e053-2995a90a459c
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Granules India Ltd
Application ANDA091353
Marketing category ANDA
Marketing start 2011-09-30
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 NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 62207-762 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-21 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-22 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-24 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-28 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-31 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-32 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-33 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-34 UNFINISHED Active or certified unfinished drug listing 2026-07-31 unfinished package package 62207-762 62207-762-36 UNFINISHED Active or certified unfinished drug listing 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091353-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20
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.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
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 Identifiers# Field, Values table Field Values Unii 9TN87S3A3C Rxcui 849574
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62207-762-42 Naproxen Sodium 50 in 1 BOTTLE TABLET, FILM COATED 50 9 62207-762-43 Naproxen Sodium 100 in 1 BOTTLE TABLET, FILM COATED 100 9 62207-762-47 Naproxen Sodium 500 in 1 BOTTLE TABLET, FILM COATED 500 9 62207-762-49 Naproxen Sodium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-762 NAPROXEN SODIUM TABLET NAPROXEN SODIUM TABLET, FILM COATED [GRANULES INDIA LTD] 9 Current NDC, Legacy NDC, 4 package rows 20230207_95ba1722-60ed-4a83-9f26-50c4de8cf180.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 62207-762-21 62207076221 5000 TABLET, FILM COATED in 1 BOX (62207-762-21) 12-MAR-14 Current 62207-762-22 62207076222 25000 TABLET, FILM COATED in 1 BOX (62207-762-22) 12-MAR-14 Current 62207-762-24 62207076224 48000 TABLET, FILM COATED in 1 BOX (62207-762-24) 12-MAR-14 Current 62207-762-28 62207076228 50000 TABLET, FILM COATED in 1 BOX (62207-762-28) 12-MAR-14 Current 62207-762-31 62207076231 5000 TABLET, FILM COATED in 1 POUCH (62207-762-31) 12-MAR-14 Current 62207-762-32 62207076232 10000 TABLET, FILM COATED in 1 POUCH (62207-762-32) 12-MAR-14 Current 62207-762-33 62207076233 25000 TABLET, FILM COATED in 1 POUCH (62207-762-33) 12-MAR-14 Current 62207-762-34 62207076234 15000 TABLET, FILM COATED in 1 POUCH (62207-762-34) 12-MAR-14 Current 62207-762-36 62207076236 50000 TABLET, FILM COATED in 1 POUCH (62207-762-36) 12-MAR-14 Current 62207-762-42 62207076242 50 TABLET, FILM COATED in 1 BOTTLE (62207-762-42) 2011-09-30 0000-00-00 No No Current 62207-762-43 62207076243 100 TABLET, FILM COATED in 1 BOTTLE (62207-762-43) 2011-09-30 0000-00-00 No No Current 62207-762-47 62207076247 500 TABLET, FILM COATED in 1 BOTTLE (62207-762-47) 2011-09-30 0000-00-00 No No Current 62207-762-49 62207076249 1000 TABLET, FILM COATED in 1 BOTTLE (62207-762-49) 2011-09-30 0000-00-00 No No Current