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 SUSPENSION
Routes
ORAL
Active Ingredients

naproxen 125 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-528
Product ID 59651-528_570974d4-0d5b-4df2-b307-37380511835d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216504
Listing Expiration 2026-12-31
Marketing Start 2025-10-03

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 59651528
Hyphenated Format 59651-528

Supplemental Identifiers

RxCUI
311913
UPC
0359651528471
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 ANDA216504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE
source: ndc

Packages (1)

59651-528-47 1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE

Ingredients (1)

naproxen (125 mg/5mL)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "570974d4-0d5b-4df2-b307-37380511835d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0359651528471"], "unii": ["57Y76R9ATQ"], "rxcui": ["311913"], "spl_set_id": ["570974d4-0d5b-4df2-b307-37380511835d"], "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": "1 BOTTLE in 1 CARTON (59651-528-47)  / 473 mL in 1 BOTTLE", "package_ndc": "59651-528-47", "marketing_start_date": "20251003"}], "brand_name": "Naproxen", "product_id": "59651-528_570974d4-0d5b-4df2-b307-37380511835d", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "59651-528", "generic_name": "Naproxen", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "125 mg/5mL"}], "application_number": "ANDA216504", "marketing_category": "ANDA", "marketing_start_date": "20251003", "listing_expiration_date": "20261231"}