naproxen

Generic: naproxen

Labeler: granules pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 500 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-139
Product ID 70010-139_451b46b7-e6fb-8436-e063-6294a90adcf1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074140
Listing Expiration 2026-12-31
Marketing Start 2021-04-15

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010139
Hyphenated Format 70010-139

Supplemental Identifiers

RxCUI
198012 198013 198014
UPC
0370010137011 0370010138018 0370010139015
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

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 (source: ndc)
Generic Name naproxen (source: ndc)
Application Number ANDA074140 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70010-139-01)
  • 500 TABLET in 1 BOTTLE (70010-139-05)
  • 1000 TABLET in 1 BOTTLE (70010-139-10)
source: ndc

Packages (3)

70010-139-01 100 TABLET in 1 BOTTLE (70010-139-01) 70010-139-05 500 TABLET in 1 BOTTLE (70010-139-05) 70010-139-10 1000 TABLET in 1 BOTTLE (70010-139-10)

Ingredients (1)

naproxen (500 mg/1)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "451b46b7-e6fb-8436-e063-6294a90adcf1", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0370010137011", "0370010138018", "0370010139015"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["c1cb9bb9-fbae-5e5c-e053-2995a90a0d21"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70010-139-01)", "package_ndc": "70010-139-01", "marketing_start_date": "20210415"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70010-139-05)", "package_ndc": "70010-139-05", "marketing_start_date": "20210415"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (70010-139-10)", "package_ndc": "70010-139-10", "marketing_start_date": "20210415"}], "brand_name": "Naproxen", "product_id": "70010-139_451b46b7-e6fb-8436-e063-6294a90adcf1", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70010-139", "generic_name": "Naproxen", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA074140", "marketing_category": "ANDA", "marketing_start_date": "20210415", "listing_expiration_date": "20261231"}