naproxen

Generic: naproxen

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

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 375 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8844
Product ID 68788-8844_727913f6-9542-4a2d-9318-4b7ff521bffd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078250
Listing Expiration 2026-12-31
Marketing Start 2025-03-20

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 687888844
Hyphenated Format 68788-8844

Supplemental Identifiers

RxCUI
198012
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 ANDA078250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8844-1)
  • 20 TABLET in 1 BOTTLE (68788-8844-2)
  • 30 TABLET in 1 BOTTLE (68788-8844-3)
  • 60 TABLET in 1 BOTTLE (68788-8844-6)
  • 120 TABLET in 1 BOTTLE (68788-8844-8)
  • 90 TABLET in 1 BOTTLE (68788-8844-9)
source: ndc

Packages (6)

68788-8844-1 100 TABLET in 1 BOTTLE (68788-8844-1) 68788-8844-2 20 TABLET in 1 BOTTLE (68788-8844-2) 68788-8844-3 30 TABLET in 1 BOTTLE (68788-8844-3) 68788-8844-6 60 TABLET in 1 BOTTLE (68788-8844-6) 68788-8844-8 120 TABLET in 1 BOTTLE (68788-8844-8) 68788-8844-9 90 TABLET in 1 BOTTLE (68788-8844-9)

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": "727913f6-9542-4a2d-9318-4b7ff521bffd", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012"], "spl_set_id": ["727913f6-9542-4a2d-9318-4b7ff521bffd"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8844-1)", "package_ndc": "68788-8844-1", "marketing_start_date": "20250320"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-8844-2)", "package_ndc": "68788-8844-2", "marketing_start_date": "20250320"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8844-3)", "package_ndc": "68788-8844-3", "marketing_start_date": "20250320"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8844-6)", "package_ndc": "68788-8844-6", "marketing_start_date": "20250320"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68788-8844-8)", "package_ndc": "68788-8844-8", "marketing_start_date": "20250320"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8844-9)", "package_ndc": "68788-8844-9", "marketing_start_date": "20250320"}], "brand_name": "Naproxen", "product_id": "68788-8844_727913f6-9542-4a2d-9318-4b7ff521bffd", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68788-8844", "generic_name": "Naproxen", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "375 mg/1"}], "application_number": "ANDA078250", "marketing_category": "ANDA", "marketing_start_date": "20250320", "listing_expiration_date": "20261231"}