naproxen sodium

Generic: naproxen sodium

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler top care (topco associates llc)
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-204
Product ID 36800-204_f0fce18a-cc1c-347f-e053-2a95a90ac3b9
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021920
Listing Expiration 2026-12-31
Marketing Start 2021-07-02

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 36800204
Hyphenated Format 36800-204

Supplemental Identifiers

RxCUI
1112231
UPC
0036800327436
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 NDA021920 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

36800-204-11 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 36800-204-16 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 36800-204-78 1 BOTTLE, PLASTIC in 1 CARTON (36800-204-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

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": "f0fce18a-cc1c-347f-e053-2a95a90ac3b9", "openfda": {"upc": ["0036800327436"], "unii": ["9TN87S3A3C"], "rxcui": ["1112231"], "spl_set_id": ["c62b7fa0-5ae9-276c-e053-2995a90ade25"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (36800-204-11)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "36800-204-11", "marketing_start_date": "20210702"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (36800-204-16)  / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "36800-204-16", "marketing_start_date": "20210702"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (36800-204-78)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "36800-204-78", "marketing_start_date": "20210702"}], "brand_name": "Naproxen Sodium", "product_id": "36800-204_f0fce18a-cc1c-347f-e053-2a95a90ac3b9", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "36800-204", "generic_name": "Naproxen Sodium", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "NDA021920", "marketing_category": "NDA", "marketing_start_date": "20210702", "listing_expiration_date": "20261231"}