naproxen

Generic: naproxen sodium

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naproxen sodium 220 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5039
Product ID 68071-5039_2d53b71b-770a-e12d-e063-6294a90a5478
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204872
Listing Expiration 2026-12-31
Marketing Start 2019-01-01

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 680715039
Hyphenated Format 68071-5039

Supplemental Identifiers

RxCUI
849574
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 (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA204872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 21 TABLET in 1 BOTTLE (68071-5039-1)
source: ndc

Packages (1)

68071-5039-1 21 TABLET in 1 BOTTLE (68071-5039-1)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d53b71b-770a-e12d-e063-6294a90a5478", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["f1ed8384-83d6-6f2a-e053-2a95a90ab08f"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET in 1 BOTTLE (68071-5039-1)", "package_ndc": "68071-5039-1", "marketing_start_date": "20230110"}], "brand_name": "Naproxen", "product_id": "68071-5039_2d53b71b-770a-e12d-e063-6294a90a5478", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68071-5039", "generic_name": "Naproxen Sodium", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA204872", "marketing_category": "ANDA", "marketing_start_date": "20190101", "listing_expiration_date": "20261231"}