naproxen sodium

Generic: naproxen sodium

Labeler: humanwell puracap pharmaceuticals (wuhan) co., ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler humanwell puracap pharmaceuticals (wuhan) co., ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd

Identifiers & Regulatory

Product NDC 53345-042
Product ID 53345-042_1b92fe6c-7407-40e0-bcb2-27a62f4399a9
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 53345042
Hyphenated Format 53345-042

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 BAG in 1 BOX (53345-042-01) / 5000 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

53345-042-01 1 BAG in 1 BOX (53345-042-01) / 5000 CAPSULE, LIQUID FILLED in 1 BAG

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": "1b92fe6c-7407-40e0-bcb2-27a62f4399a9", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["1112231"], "spl_set_id": ["1d5981dd-e3f5-48a3-a5f1-ce49689cdfac"], "manufacturer_name": ["Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-042-01)  / 5000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-042-01", "marketing_start_date": "20180320"}], "brand_name": "NAPROXEN SODIUM", "product_id": "53345-042_1b92fe6c-7407-40e0-bcb2-27a62f4399a9", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53345-042", "generic_name": "Naproxen Sodium", "labeler_name": "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "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"}