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 72789-321
Product ID 72789-321_47a9956b-6ea0-c241-e063-6394a90ab439
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212517
Listing Expiration 2027-12-31
Marketing Start 2020-03-01

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 72789321
Hyphenated Format 72789-321

Supplemental Identifiers

RxCUI
198014
UPC
0372789321301
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 ANDA212517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE, PLASTIC (72789-321-04)
  • 15 TABLET in 1 BOTTLE, PLASTIC (72789-321-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (72789-321-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-321-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (72789-321-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-321-90)
source: ndc

Packages (6)

72789-321-04 4 TABLET in 1 BOTTLE, PLASTIC (72789-321-04) 72789-321-15 15 TABLET in 1 BOTTLE, PLASTIC (72789-321-15) 72789-321-20 20 TABLET in 1 BOTTLE, PLASTIC (72789-321-20) 72789-321-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-321-30) 72789-321-60 60 TABLET in 1 BOTTLE, PLASTIC (72789-321-60) 72789-321-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-321-90)

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": "47a9956b-6ea0-c241-e063-6394a90ab439", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0372789321301"], "unii": ["57Y76R9ATQ"], "rxcui": ["198014"], "spl_set_id": ["fa2fe6fd-c476-dd29-e053-6294a90a9e9e"], "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 (72789-321-04)", "package_ndc": "72789-321-04", "marketing_start_date": "20231115"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (72789-321-15)", "package_ndc": "72789-321-15", "marketing_start_date": "20230609"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (72789-321-20)", "package_ndc": "72789-321-20", "marketing_start_date": "20230801"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-321-30)", "package_ndc": "72789-321-30", "marketing_start_date": "20230425"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (72789-321-60)", "package_ndc": "72789-321-60", "marketing_start_date": "20230612"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-321-90)", "package_ndc": "72789-321-90", "marketing_start_date": "20230929"}], "brand_name": "Naproxen", "product_id": "72789-321_47a9956b-6ea0-c241-e063-6394a90ab439", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72789-321", "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": "ANDA212517", "marketing_category": "ANDA", "marketing_start_date": "20200301", "listing_expiration_date": "20271231"}