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, DELAYED RELEASE
Routes
ORAL
Active Ingredients

naproxen 500 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 66267-373
Product ID 66267-373_1fa6c8e0-0ee3-12f2-e063-6294a90a8951
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091432
Listing Expiration 2026-12-31
Marketing Start 2016-07-05

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 66267373
Hyphenated Format 66267-373

Supplemental Identifiers

RxCUI
311915
UPC
0366267373203
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 ANDA091432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 20 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-20)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-60)
source: ndc

Packages (3)

66267-373-20 20 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-20) 66267-373-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-30) 66267-373-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-60)

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": "1fa6c8e0-0ee3-12f2-e063-6294a90a8951", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0366267373203"], "unii": ["57Y76R9ATQ"], "rxcui": ["311915"], "spl_set_id": ["5e873524-f9fb-fe2d-e053-2991aa0aa0a5"], "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, DELAYED RELEASE in 1 BOTTLE (66267-373-20)", "package_ndc": "66267-373-20", "marketing_start_date": "20171121"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-30)", "package_ndc": "66267-373-30", "marketing_start_date": "20171121"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-60)", "package_ndc": "66267-373-60", "marketing_start_date": "20171121"}], "brand_name": "Naproxen", "product_id": "66267-373_1fa6c8e0-0ee3-12f2-e063-6294a90a8951", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "66267-373", "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": "ANDA091432", "marketing_category": "ANDA", "marketing_start_date": "20160705", "listing_expiration_date": "20261231"}