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 250 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4510
Product ID 68071-4510_1a9069a4-cca5-c841-e063-6394a90ad4d2
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 680714510
Hyphenated Format 68071-4510

Supplemental Identifiers

RxCUI
198013
UPC
0368071451061
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
  • 250 mg/1
source: ndc
Packaging
  • 6 TABLET in 1 BOTTLE (68071-4510-6)
source: ndc

Packages (1)

68071-4510-6 6 TABLET in 1 BOTTLE (68071-4510-6)

Ingredients (1)

naproxen (250 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": "1a9069a4-cca5-c841-e063-6394a90ad4d2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368071451061"], "unii": ["57Y76R9ATQ"], "rxcui": ["198013"], "spl_set_id": ["71d4a048-ca50-73db-e053-2a95a90ad465"], "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": "6 TABLET in 1 BOTTLE (68071-4510-6)", "package_ndc": "68071-4510-6", "marketing_start_date": "20180725"}], "brand_name": "NAPROXEN", "product_id": "68071-4510_1a9069a4-cca5-c841-e063-6394a90ad4d2", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68071-4510", "generic_name": "NAPROXEN", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NAPROXEN", "active_ingredients": [{"name": "NAPROXEN", "strength": "250 mg/1"}], "application_number": "ANDA091416", "marketing_category": "ANDA", "marketing_start_date": "20160706", "listing_expiration_date": "20261231"}