naproxen sodium

Generic: naproxen sodium

Labeler: puracap pharmaceutical llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler puracap pharmaceutical llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
PuraCap Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 51013-137
Product ID 51013-137_9a223804-f229-442b-85a9-7f0f8fd74ba1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208363
Listing Expiration 2026-12-31
Marketing Start 2018-03-20

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 51013137
Hyphenated Format 51013-137

Supplemental Identifiers

RxCUI
1112231
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 ANDA208363 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51013-137-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51013-137-28) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-137-60)
source: ndc

Packages (3)

51013-137-15 1 BOTTLE in 1 CARTON (51013-137-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 51013-137-28 1 BOTTLE in 1 CARTON (51013-137-28) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE 51013-137-60 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-137-60)

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": "9a223804-f229-442b-85a9-7f0f8fd74ba1", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["1112231"], "spl_set_id": ["fc865e81-164c-48e9-8fb9-6fc27d1c33cf"], "manufacturer_name": ["PuraCap Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51013-137-15)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "51013-137-15", "marketing_start_date": "20180320"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51013-137-28)  / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "51013-137-28", "marketing_start_date": "20180320"}, {"sample": false, "description": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-137-60)", "package_ndc": "51013-137-60", "marketing_start_date": "20180320"}], "brand_name": "NAPROXEN SODIUM", "product_id": "51013-137_9a223804-f229-442b-85a9-7f0f8fd74ba1", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "51013-137", "generic_name": "Naproxen Sodium", "labeler_name": "PuraCap Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NAPROXEN SODIUM", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA208363", "marketing_category": "ANDA", "marketing_start_date": "20180320", "listing_expiration_date": "20261231"}