naproxen

Generic: naproxen

Labeler: boswell pharmacy services llc d/b/a bps wholesale
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler boswell pharmacy services llc d/b/a bps wholesale
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 500 mg/1

Manufacturer
Boswell Pharmacy Services LLC d/b/a BPS Wholesale

Identifiers & Regulatory

Product NDC 83209-190
Product ID 83209-190_205aec1c-4e2f-8e0f-e063-6294a90a4ff0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078250
Listing Expiration 2026-12-31
Marketing Start 2024-08-23

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 83209190
Hyphenated Format 83209-190

Supplemental Identifiers

RxCUI
198014
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
  • 500 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BLISTER PACK (83209-190-14)
  • 15 TABLET in 1 BLISTER PACK (83209-190-15)
  • 18 TABLET in 1 BLISTER PACK (83209-190-18)
  • 20 TABLET in 1 BLISTER PACK (83209-190-20)
  • 28 TABLET in 1 BLISTER PACK (83209-190-28)
  • 30 TABLET in 1 BLISTER PACK (83209-190-30)
  • 60 TABLET in 1 BLISTER PACK (83209-190-60)
source: ndc

Packages (7)

Ingredients (1)

naproxen (500 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "205aec1c-4e2f-8e0f-e063-6294a90a4ff0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198014"], "spl_set_id": ["205b1159-06e5-0d48-e063-6294a90acbd8"], "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": ["Boswell Pharmacy Services LLC d/b/a BPS Wholesale"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BLISTER PACK (83209-190-14)", "package_ndc": "83209-190-14", "marketing_start_date": "20240823"}, {"sample": false, "description": "15 TABLET in 1 BLISTER PACK (83209-190-15)", "package_ndc": "83209-190-15", "marketing_start_date": "20240823"}, {"sample": false, "description": "18 TABLET in 1 BLISTER PACK (83209-190-18)", "package_ndc": "83209-190-18", "marketing_start_date": "20240823"}, {"sample": false, "description": "20 TABLET in 1 BLISTER PACK (83209-190-20)", "package_ndc": "83209-190-20", "marketing_start_date": "20240823"}, {"sample": false, "description": "28 TABLET in 1 BLISTER PACK (83209-190-28)", "package_ndc": "83209-190-28", "marketing_start_date": "20240823"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (83209-190-30)", "package_ndc": "83209-190-30", "marketing_start_date": "20240823"}, {"sample": false, "description": "60 TABLET in 1 BLISTER PACK (83209-190-60)", "package_ndc": "83209-190-60", "marketing_start_date": "20240823"}], "brand_name": "Naproxen", "product_id": "83209-190_205aec1c-4e2f-8e0f-e063-6294a90a4ff0", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83209-190", "generic_name": "Naproxen", "labeler_name": "Boswell Pharmacy Services LLC d/b/a BPS Wholesale", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA078250", "marketing_category": "ANDA", "marketing_start_date": "20240823", "listing_expiration_date": "20261231"}