naproxen

Generic: naproxen

Labeler: ncs healthcare of ky, inc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler ncs healthcare of ky, inc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 500 mg/1

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8094
Product ID 0615-8094_0aa460fe-3ac9-4b38-8e2b-8a59e5cb3563
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 06158094
Hyphenated Format 0615-8094

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 ANDA075927 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (0615-8094-39)
source: ndc

Packages (1)

0615-8094-39 30 TABLET in 1 BLISTER PACK (0615-8094-39)

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": "0aa460fe-3ac9-4b38-8e2b-8a59e5cb3563", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198014"], "spl_set_id": ["62a12771-bde9-4bc3-9ce9-672c8e31f020"], "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": ["NCS HealthCare of KY, Inc dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8094-39)", "package_ndc": "0615-8094-39", "marketing_start_date": "20100218"}], "brand_name": "Naproxen", "product_id": "0615-8094_0aa460fe-3ac9-4b38-8e2b-8a59e5cb3563", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0615-8094", "generic_name": "Naproxen", "labeler_name": "NCS HealthCare of KY, Inc dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA075927", "marketing_category": "ANDA", "marketing_start_date": "20100218", "listing_expiration_date": "20261231"}