naproxen

Generic: naproxen

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

Drug Facts

Product Profile

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

naproxen 500 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4381
Product ID 68071-4381_1a55650f-46fe-95c3-e063-6294a90a9fc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091416
Listing Expiration 2026-12-31
Marketing Start 2016-07-06

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 680714381
Hyphenated Format 68071-4381

Supplemental Identifiers

RxCUI
198014
UPC
0368071438161
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

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 ANDA091416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (68071-4381-2)
  • 4 TABLET in 1 BOTTLE (68071-4381-4)
  • 6 TABLET in 1 BOTTLE (68071-4381-6)
source: ndc

Packages (3)

68071-4381-2 20 TABLET in 1 BOTTLE (68071-4381-2) 68071-4381-4 4 TABLET in 1 BOTTLE (68071-4381-4) 68071-4381-6 6 TABLET in 1 BOTTLE (68071-4381-6)

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": "1a55650f-46fe-95c3-e063-6294a90a9fc3", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368071438161"], "unii": ["57Y76R9ATQ"], "rxcui": ["198014"], "spl_set_id": ["69366b55-2687-17a4-e053-2a91aa0a65b3"], "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": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (68071-4381-2)", "package_ndc": "68071-4381-2", "marketing_start_date": "20180406"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE (68071-4381-4)", "package_ndc": "68071-4381-4", "marketing_start_date": "20180406"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (68071-4381-6)", "package_ndc": "68071-4381-6", "marketing_start_date": "20180406"}], "brand_name": "NAPROXEN", "product_id": "68071-4381_1a55650f-46fe-95c3-e063-6294a90a9fc3", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68071-4381", "generic_name": "NAPROXEN", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NAPROXEN", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA091416", "marketing_category": "ANDA", "marketing_start_date": "20160706", "listing_expiration_date": "20261231"}