naproxen

Generic: naproxen

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

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-925
Product ID 70954-925_5c522cd1-1631-4254-ae44-cef65573b29f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218497
Listing Expiration 2026-12-31
Marketing Start 2024-06-13

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 70954925
Hyphenated Format 70954-925

Supplemental Identifiers

RxCUI
311915 603103
UPC
0370954925101 0370954928102
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 ANDA218497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-925-10)
source: ndc

Packages (1)

70954-925-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-925-10)

Ingredients (1)

naproxen (375 mg/1)

Linked Drug Pages (1)

Naproxen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5c522cd1-1631-4254-ae44-cef65573b29f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0370954925101", "0370954928102"], "unii": ["57Y76R9ATQ"], "rxcui": ["311915", "603103"], "spl_set_id": ["052e6fe3-d619-42c3-b64e-67c7aaf7271c"], "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": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-925-10)", "package_ndc": "70954-925-10", "marketing_start_date": "20240613"}], "brand_name": "Naproxen", "product_id": "70954-925_5c522cd1-1631-4254-ae44-cef65573b29f", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70954-925", "generic_name": "Naproxen", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA218497", "marketing_category": "ANDA", "marketing_start_date": "20240613", "listing_expiration_date": "20261231"}