naproxen sodium

Generic: naproxen sodium

Labeler: spirit pharmaceuticals,llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler spirit pharmaceuticals,llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
SPIRIT PHARMACEUTICALS,LLC

Identifiers & Regulatory

Product NDC 68210-4096
Product ID 68210-4096_2a8235d0-4618-0572-e063-6394a90a0d1a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091353
Listing Expiration 2026-12-31
Marketing Start 2020-07-02

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 682104096
Hyphenated Format 68210-4096

Supplemental Identifiers

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 ANDA091353 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 365 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-4096-1)
source: ndc

Packages (1)

68210-4096-1 365 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-4096-1)

Ingredients (1)

naproxen sodium (220 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": "2a8235d0-4618-0572-e063-6394a90a0d1a", "openfda": {"unii": ["9TN87S3A3C"], "spl_set_id": ["a690dc39-95f2-4853-a291-05d7dc9a1551"], "manufacturer_name": ["SPIRIT PHARMACEUTICALS,LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "365 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-4096-1)", "package_ndc": "68210-4096-1", "marketing_start_date": "20200702"}], "brand_name": "NAPROXEN SODIUM", "product_id": "68210-4096_2a8235d0-4618-0572-e063-6394a90a0d1a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68210-4096", "generic_name": "NAPROXEN SODIUM", "labeler_name": "SPIRIT PHARMACEUTICALS,LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NAPROXEN SODIUM", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA091353", "marketing_category": "ANDA", "marketing_start_date": "20200702", "listing_expiration_date": "20261231"}