naproxen sodium

Generic: naproxen sodium

Labeler: productos zapotol corp.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler productos zapotol corp.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Productos Zapotol Corp.

Identifiers & Regulatory

Product NDC 59428-748
Product ID 59428-748_0b680442-f001-4b6c-a520-e063be6239ec
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208363
Listing Expiration 2026-12-31
Marketing Start 2024-04-30

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 59428748
Hyphenated Format 59428-748

Supplemental Identifiers

RxCUI
1112231
UPC
0359726748223
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, PLASTIC in 1 BOX (59428-748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "0b680442-f001-4b6c-a520-e063be6239ec", "openfda": {"upc": ["0359726748223"], "unii": ["9TN87S3A3C"], "rxcui": ["1112231"], "spl_set_id": ["6386f6f6-9bc7-4b85-ac87-03fd14725904"], "manufacturer_name": ["Productos Zapotol Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (59428-748-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "59428-748-20", "marketing_start_date": "20240430"}], "brand_name": "Naproxen Sodium", "product_id": "59428-748_0b680442-f001-4b6c-a520-e063be6239ec", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "59428-748", "generic_name": "Naproxen Sodium", "labeler_name": "Productos Zapotol Corp.", "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": "20240430", "listing_expiration_date": "20261231"}