naproxen

Generic: naproxen

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 250 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-600
Product ID 43063-600_39f936c5-d0d1-6804-e063-6394a90add94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075927
Listing Expiration 2026-12-31
Marketing Start 2010-02-18

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 43063600
Hyphenated Format 43063-600

Supplemental Identifiers

RxCUI
198013
UPC
0343063600153
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

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 ANDA075927 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 6 TABLET in 1 BOTTLE, PLASTIC (43063-600-06)
  • 15 TABLET in 1 BOTTLE, PLASTIC (43063-600-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (43063-600-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-600-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-600-60)
source: ndc

Packages (5)

43063-600-06 6 TABLET in 1 BOTTLE, PLASTIC (43063-600-06) 43063-600-15 15 TABLET in 1 BOTTLE, PLASTIC (43063-600-15) 43063-600-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-600-20) 43063-600-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-600-30) 43063-600-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-600-60)

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": "39f936c5-d0d1-6804-e063-6394a90add94", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0343063600153"], "unii": ["57Y76R9ATQ"], "rxcui": ["198013"], "spl_set_id": ["6573681e-e9be-440f-a818-a533b744648e"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (43063-600-06)", "package_ndc": "43063-600-06", "marketing_start_date": "20150826"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (43063-600-15)", "package_ndc": "43063-600-15", "marketing_start_date": "20150826"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (43063-600-20)", "package_ndc": "43063-600-20", "marketing_start_date": "20150826"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-600-30)", "package_ndc": "43063-600-30", "marketing_start_date": "20150826"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-600-60)", "package_ndc": "43063-600-60", "marketing_start_date": "20150826"}], "brand_name": "Naproxen", "product_id": "43063-600_39f936c5-d0d1-6804-e063-6394a90add94", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-600", "generic_name": "Naproxen", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "250 mg/1"}], "application_number": "ANDA075927", "marketing_category": "ANDA", "marketing_start_date": "20100218", "listing_expiration_date": "20261231"}