naproxen

Generic: naproxen

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler hikma pharmaceuticals usa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

naproxen 125 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3630
Product ID 0054-3630_ce07dc5c-441e-4f1c-a940-077306017c43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074190
Listing Expiration 2026-12-31
Marketing Start 2021-02-24

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 00543630
Hyphenated Format 0054-3630

Supplemental Identifiers

RxCUI
311913
UPC
0300543630635
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 ANDA074190 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE, PLASTIC (0054-3630-63)
source: ndc

Packages (1)

0054-3630-63 500 mL in 1 BOTTLE, PLASTIC (0054-3630-63)

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": "ce07dc5c-441e-4f1c-a940-077306017c43", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0300543630635"], "unii": ["57Y76R9ATQ"], "rxcui": ["311913"], "spl_set_id": ["a5757b1a-62c9-4421-9794-6fb121ce9b7e"], "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": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE, PLASTIC (0054-3630-63)", "package_ndc": "0054-3630-63", "marketing_start_date": "20210224"}], "brand_name": "Naproxen", "product_id": "0054-3630_ce07dc5c-441e-4f1c-a940-077306017c43", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0054-3630", "generic_name": "Naproxen", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "125 mg/5mL"}], "application_number": "ANDA074190", "marketing_category": "ANDA", "marketing_start_date": "20210224", "listing_expiration_date": "20261231"}