naproxen

Generic: naproxen

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler aurobindo pharma limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-986
Product ID 59651-986_67815abd-5e97-4ccb-ac9b-28c2ef6123e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075390
Listing Expiration 2026-12-31
Marketing Start 2025-05-08

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 59651986
Hyphenated Format 59651-986

Supplemental Identifiers

RxCUI
311915 603103
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 ANDA075390 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-01)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-05)
source: ndc

Packages (2)

59651-986-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-01) 59651-986-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-05)

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": "67815abd-5e97-4ccb-ac9b-28c2ef6123e7", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["311915", "603103"], "spl_set_id": ["67815abd-5e97-4ccb-ac9b-28c2ef6123e7"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-01)", "package_ndc": "59651-986-01", "marketing_start_date": "20250508"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-05)", "package_ndc": "59651-986-05", "marketing_start_date": "20250508"}], "brand_name": "Naproxen", "product_id": "59651-986_67815abd-5e97-4ccb-ac9b-28c2ef6123e7", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "59651-986", "generic_name": "Naproxen", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA075390", "marketing_category": "ANDA", "marketing_start_date": "20250508", "listing_expiration_date": "20261231"}