naproxen

Generic: naproxen

Labeler: marksans pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler marksans pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 250 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-138
Product ID 25000-138_e5013319-e2f4-4cd0-9523-1ffd352fe2d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091416
Listing Expiration 2026-12-31
Marketing Start 2011-02-28

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 25000138
Hyphenated Format 25000-138

Supplemental Identifiers

RxCUI
198012 198013 198014
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 ANDA091416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (25000-138-03)
  • 1000 TABLET in 1 BOTTLE (25000-138-14)
  • 4 BAG in 1 BOX (25000-138-21) / 7500 TABLET in 1 BAG
  • 6 BAG in 1 BOX (25000-138-31) / 7500 TABLET in 1 BAG
  • 1 BAG in 1 BOX (25000-138-98) / 37950 TABLET in 1 BAG
source: ndc

Packages (5)

25000-138-03 30 TABLET in 1 BOTTLE (25000-138-03) 25000-138-14 1000 TABLET in 1 BOTTLE (25000-138-14) 25000-138-21 4 BAG in 1 BOX (25000-138-21) / 7500 TABLET in 1 BAG 25000-138-31 6 BAG in 1 BOX (25000-138-31) / 7500 TABLET in 1 BAG 25000-138-98 1 BAG in 1 BOX (25000-138-98) / 37950 TABLET in 1 BAG

Ingredients (1)

naproxen (250 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": "e5013319-e2f4-4cd0-9523-1ffd352fe2d9", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8"], "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": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (25000-138-03)", "package_ndc": "25000-138-03", "marketing_start_date": "20110228"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (25000-138-14)", "package_ndc": "25000-138-14", "marketing_start_date": "20110228"}, {"sample": false, "description": "4 BAG in 1 BOX (25000-138-21)  / 7500 TABLET in 1 BAG", "package_ndc": "25000-138-21", "marketing_start_date": "20110228"}, {"sample": false, "description": "6 BAG in 1 BOX (25000-138-31)  / 7500 TABLET in 1 BAG", "package_ndc": "25000-138-31", "marketing_start_date": "20110228"}, {"sample": false, "description": "1 BAG in 1 BOX (25000-138-98)  / 37950 TABLET in 1 BAG", "package_ndc": "25000-138-98", "marketing_start_date": "20110228"}], "brand_name": "Naproxen", "product_id": "25000-138_e5013319-e2f4-4cd0-9523-1ffd352fe2d9", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "25000-138", "generic_name": "Naproxen", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "250 mg/1"}], "application_number": "ANDA091416", "marketing_category": "ANDA", "marketing_start_date": "20110228", "listing_expiration_date": "20261231"}