naproxen

Generic: naproxen

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler amneal pharmaceuticals ny llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

naproxen 25 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1730
Product ID 69238-1730_3b37ffd3-034c-424c-bca0-72f15d719633
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212705
Listing Expiration 2026-12-31
Marketing Start 2020-08-03

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 692381730
Hyphenated Format 69238-1730

Supplemental Identifiers

RxCUI
311913
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 ANDA212705 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (69238-1730-2)
source: ndc

Packages (1)

69238-1730-2 473 mL in 1 BOTTLE (69238-1730-2)

Ingredients (1)

naproxen (25 mg/mL)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b37ffd3-034c-424c-bca0-72f15d719633", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["311913"], "spl_set_id": ["985aedc1-8b3c-4cb4-af13-7203a2b57ab7"], "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": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (69238-1730-2)", "package_ndc": "69238-1730-2", "marketing_start_date": "20200803"}], "brand_name": "Naproxen", "product_id": "69238-1730_3b37ffd3-034c-424c-bca0-72f15d719633", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69238-1730", "generic_name": "Naproxen", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "25 mg/mL"}], "application_number": "ANDA212705", "marketing_category": "ANDA", "marketing_start_date": "20200803", "listing_expiration_date": "20261231"}