naproxen sodium

Generic: naproxen sodium

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen sodium 550 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-627
Product ID 76420-627_07f76fa9-dba3-997b-e063-6294a90a6dd5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212199
Listing Expiration 2026-12-31
Marketing Start 2019-10-30

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 76420627
Hyphenated Format 76420-627

Supplemental Identifiers

RxCUI
849398 849431
UNII
9TN87S3A3C

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 ANDA212199 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 550 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-627-01)
  • 30 TABLET in 1 BOTTLE (76420-627-30)
  • 60 TABLET in 1 BOTTLE (76420-627-60)
  • 90 TABLET in 1 BOTTLE (76420-627-90)
source: ndc

Packages (4)

76420-627-01 100 TABLET in 1 BOTTLE (76420-627-01) 76420-627-30 30 TABLET in 1 BOTTLE (76420-627-30) 76420-627-60 60 TABLET in 1 BOTTLE (76420-627-60) 76420-627-90 90 TABLET in 1 BOTTLE (76420-627-90)

Ingredients (1)

naproxen sodium (550 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": "07f76fa9-dba3-997b-e063-6294a90a6dd5", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849398", "849431"], "spl_set_id": ["b0571e62-9330-438d-a2ba-873477f52dc4"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-627-01)", "package_ndc": "76420-627-01", "marketing_start_date": "20231018"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-627-30)", "package_ndc": "76420-627-30", "marketing_start_date": "20231018"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-627-60)", "package_ndc": "76420-627-60", "marketing_start_date": "20231018"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-627-90)", "package_ndc": "76420-627-90", "marketing_start_date": "20231018"}], "brand_name": "Naproxen Sodium", "product_id": "76420-627_07f76fa9-dba3-997b-e063-6294a90a6dd5", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-627", "generic_name": "Naproxen Sodium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "550 mg/1"}], "application_number": "ANDA212199", "marketing_category": "ANDA", "marketing_start_date": "20191030", "listing_expiration_date": "20261231"}