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 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-920
Product ID 43063-920_415db902-541e-accc-e063-6394a90a54e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091416
Listing Expiration 2026-12-31
Marketing Start 2016-07-06

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 43063920
Hyphenated Format 43063-920

Supplemental Identifiers

RxCUI
198014
UPC
0343063920305
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 ANDA091416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE, PLASTIC (43063-920-04)
  • 6 TABLET in 1 BOTTLE, PLASTIC (43063-920-06)
  • 14 TABLET in 1 BOTTLE, PLASTIC (43063-920-14)
  • 15 TABLET in 1 BOTTLE, PLASTIC (43063-920-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (43063-920-20)
  • 28 TABLET in 1 BOTTLE, PLASTIC (43063-920-28)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-920-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-920-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-920-90)
source: ndc

Packages (9)

43063-920-04 4 TABLET in 1 BOTTLE, PLASTIC (43063-920-04) 43063-920-06 6 TABLET in 1 BOTTLE, PLASTIC (43063-920-06) 43063-920-14 14 TABLET in 1 BOTTLE, PLASTIC (43063-920-14) 43063-920-15 15 TABLET in 1 BOTTLE, PLASTIC (43063-920-15) 43063-920-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-920-20) 43063-920-28 28 TABLET in 1 BOTTLE, PLASTIC (43063-920-28) 43063-920-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-920-30) 43063-920-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-920-60) 43063-920-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-920-90)

Ingredients (1)

naproxen (500 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": "415db902-541e-accc-e063-6394a90a54e5", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0343063920305"], "unii": ["57Y76R9ATQ"], "rxcui": ["198014"], "spl_set_id": ["a9f9ce81-9d51-4167-9581-974866a8fe31"], "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": "4 TABLET in 1 BOTTLE, PLASTIC (43063-920-04)", "package_ndc": "43063-920-04", "marketing_start_date": "20181218"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (43063-920-06)", "package_ndc": "43063-920-06", "marketing_start_date": "20190531"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (43063-920-14)", "package_ndc": "43063-920-14", "marketing_start_date": "20190208"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (43063-920-15)", "package_ndc": "43063-920-15", "marketing_start_date": "20190116"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (43063-920-20)", "package_ndc": "43063-920-20", "marketing_start_date": "20190207"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (43063-920-28)", "package_ndc": "43063-920-28", "marketing_start_date": "20190924"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-920-30)", "package_ndc": "43063-920-30", "marketing_start_date": "20190114"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-920-60)", "package_ndc": "43063-920-60", "marketing_start_date": "20190218"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-920-90)", "package_ndc": "43063-920-90", "marketing_start_date": "20200901"}], "brand_name": "NAPROXEN", "product_id": "43063-920_415db902-541e-accc-e063-6394a90a54e5", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-920", "generic_name": "NAPROXEN", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NAPROXEN", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA091416", "marketing_category": "ANDA", "marketing_start_date": "20160706", "listing_expiration_date": "20261231"}