naproxen

Generic: naproxen

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

Drug Facts

Product Profile

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

naproxen 375 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-341
Product ID 76282-341_509fffe2-2bab-4ae4-8c53-520e1c5eff68
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091305
Listing Expiration 2026-12-31
Marketing Start 2016-06-10

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 76282341
Hyphenated Format 76282-341

Supplemental Identifiers

RxCUI
198012 198013 198014
UPC
0376282341019 0376282340012 0376282342016
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 ANDA091305 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76282-341-01)
  • 500 TABLET in 1 BOTTLE (76282-341-05)
source: ndc

Packages (2)

76282-341-01 100 TABLET in 1 BOTTLE (76282-341-01) 76282-341-05 500 TABLET in 1 BOTTLE (76282-341-05)

Ingredients (1)

naproxen (375 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": "509fffe2-2bab-4ae4-8c53-520e1c5eff68", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0376282341019", "0376282340012", "0376282342016"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["46dbdb95-a0d0-4410-8d64-b22763b12af7"], "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": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76282-341-01)", "package_ndc": "76282-341-01", "marketing_start_date": "20160610"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76282-341-05)", "package_ndc": "76282-341-05", "marketing_start_date": "20160610"}], "brand_name": "Naproxen", "product_id": "76282-341_509fffe2-2bab-4ae4-8c53-520e1c5eff68", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76282-341", "generic_name": "Naproxen", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA091305", "marketing_category": "ANDA", "marketing_start_date": "20160610", "listing_expiration_date": "20261231"}