naproxen sodium

Generic: naproxen sodium

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

Drug Facts

Product Profile

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

naproxen sodium 550 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2333
Product ID 68071-2333_2ad6c528-4120-6dec-e063-6394a90adfea
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 680712333
Hyphenated Format 68071-2333

Supplemental Identifiers

RxCUI
849431
UPC
0368071233346
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
  • 21 TABLET in 1 BOTTLE (68071-2333-2)
  • 30 TABLET in 1 BOTTLE (68071-2333-3)
  • 14 TABLET in 1 BOTTLE (68071-2333-4)
source: ndc

Packages (3)

Ingredients (1)

naproxen sodium (550 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2ad6c528-4120-6dec-e063-6394a90adfea", "openfda": {"upc": ["0368071233346"], "unii": ["9TN87S3A3C"], "rxcui": ["849431"], "spl_set_id": ["b8e417d2-3fc8-9a5e-e053-2a95a90a4155"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET in 1 BOTTLE (68071-2333-2)", "package_ndc": "68071-2333-2", "marketing_start_date": "20241219"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-2333-3)", "package_ndc": "68071-2333-3", "marketing_start_date": "20210114"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (68071-2333-4)", "package_ndc": "68071-2333-4", "marketing_start_date": "20210114"}], "brand_name": "Naproxen Sodium", "product_id": "68071-2333_2ad6c528-4120-6dec-e063-6394a90adfea", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68071-2333", "generic_name": "Naproxen Sodium", "labeler_name": "NuCare Pharmaceuticals,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"}