naproxen oral suspension

Generic: naproxen oral

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

Drug Facts

Product Profile

Brand Name naproxen oral suspension
Generic Name naproxen oral
Labeler ani pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

naproxen 125 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-151
Product ID 70954-151_1aa670cb-8d65-413a-9bdd-680cafd9b5c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211910
Listing Expiration 2026-12-31
Marketing Start 2021-03-12

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 70954151
Hyphenated Format 70954-151

Supplemental Identifiers

RxCUI
311913
UPC
0370954151104
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 oral suspension (source: ndc)
Generic Name naproxen oral (source: ndc)
Application Number ANDA211910 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (70954-151-10)
source: ndc

Packages (1)

70954-151-10 500 mL in 1 BOTTLE (70954-151-10)

Ingredients (1)

naproxen (125 mg/5mL)

Linked Drug Pages (1)

Naproxen Oral Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1aa670cb-8d65-413a-9bdd-680cafd9b5c4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0370954151104"], "unii": ["57Y76R9ATQ"], "rxcui": ["311913"], "spl_set_id": ["252726a7-757a-4b97-b5b8-ffff4ac1d103"], "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": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (70954-151-10)", "package_ndc": "70954-151-10", "marketing_start_date": "20210312"}], "brand_name": "Naproxen Oral Suspension", "product_id": "70954-151_1aa670cb-8d65-413a-9bdd-680cafd9b5c4", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70954-151", "generic_name": "Naproxen oral", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen Oral Suspension", "active_ingredients": [{"name": "NAPROXEN", "strength": "125 mg/5mL"}], "application_number": "ANDA211910", "marketing_category": "ANDA", "marketing_start_date": "20210312", "listing_expiration_date": "20261231"}