naproxen sodium

Generic: naproxen sodium

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler dr. reddy's laboratories inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 275 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-494
Product ID 43598-494_3498dec1-32e7-ecde-c86e-4c1d7cb0b080
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078486
Listing Expiration 2026-12-31
Marketing Start 2016-04-26

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598494
Hyphenated Format 43598-494

Supplemental Identifiers

RxCUI
849398 849431
UPC
0343598494012 0343598495019
UNII
9TN87S3A3C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name naproxen sodium (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA078486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 275 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (43598-494-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (43598-494-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (43598-494-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-494-30)
source: ndc

Packages (4)

43598-494-01 100 TABLET, FILM COATED in 1 BOTTLE (43598-494-01) 43598-494-05 500 TABLET, FILM COATED in 1 BOTTLE (43598-494-05) 43598-494-10 1000 TABLET, FILM COATED in 1 BOTTLE (43598-494-10) 43598-494-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-494-30)

Ingredients (1)

naproxen sodium (275 mg/1)

Linked Drug Pages (1)

Naproxen sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3498dec1-32e7-ecde-c86e-4c1d7cb0b080", "openfda": {"upc": ["0343598494012", "0343598495019"], "unii": ["9TN87S3A3C"], "rxcui": ["849398", "849431"], "spl_set_id": ["37de42a6-701b-7f6e-e631-519e2ea78b54"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (43598-494-01)", "package_ndc": "43598-494-01", "marketing_start_date": "20160426"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43598-494-05)", "package_ndc": "43598-494-05", "marketing_start_date": "20160426"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (43598-494-10)", "package_ndc": "43598-494-10", "marketing_start_date": "20160426"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43598-494-30)", "package_ndc": "43598-494-30", "marketing_start_date": "20160426"}], "brand_name": "Naproxen sodium", "product_id": "43598-494_3498dec1-32e7-ecde-c86e-4c1d7cb0b080", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43598-494", "generic_name": "Naproxen sodium", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "275 mg/1"}], "application_number": "ANDA078486", "marketing_category": "ANDA", "marketing_start_date": "20160426", "listing_expiration_date": "20261231"}