naproxen

Generic: naproxen

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

Drug Facts

Product Profile

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

naproxen 25 mg/mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-682
Product ID 31722-682_34759de3-8b17-9ab2-e063-6394a90a6a3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215776
Listing Expiration 2026-12-31
Marketing Start 2022-06-07

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 31722682
Hyphenated Format 31722-682

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 ANDA215776 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (31722-682-05)
source: ndc

Packages (1)

31722-682-05 500 mL in 1 BOTTLE (31722-682-05)

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": "34759de3-8b17-9ab2-e063-6394a90a6a3e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["311913"], "spl_set_id": ["fd5e8d84-f92c-4f4b-ab0d-4cda7cf826bd"], "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": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (31722-682-05)", "package_ndc": "31722-682-05", "marketing_start_date": "20220607"}], "brand_name": "Naproxen", "product_id": "31722-682_34759de3-8b17-9ab2-e063-6394a90a6a3e", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "31722-682", "generic_name": "Naproxen", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "25 mg/mL"}], "application_number": "ANDA215776", "marketing_category": "ANDA", "marketing_start_date": "20220607", "listing_expiration_date": "20261231"}