naproxen

Generic: naproxen

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 500 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-042
Product ID 76420-042_ead160e6-aba4-ca0a-e053-2a95a90ab964
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 76420042
Hyphenated Format 76420-042

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 ANDA091416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 TABLET in 1 BOTTLE, PLASTIC (76420-042-01)
  • 2 TABLET in 1 BOTTLE, PLASTIC (76420-042-02)
  • 100 TABLET in 1 BOTTLE, PLASTIC (76420-042-10)
  • 14 TABLET in 1 BOTTLE, PLASTIC (76420-042-14)
  • 30 TABLET in 1 BOTTLE, PLASTIC (76420-042-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (76420-042-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (76420-042-90)
source: ndc

Packages (7)

76420-042-01 1 TABLET in 1 BOTTLE, PLASTIC (76420-042-01) 76420-042-02 2 TABLET in 1 BOTTLE, PLASTIC (76420-042-02) 76420-042-10 100 TABLET in 1 BOTTLE, PLASTIC (76420-042-10) 76420-042-14 14 TABLET in 1 BOTTLE, PLASTIC (76420-042-14) 76420-042-30 30 TABLET in 1 BOTTLE, PLASTIC (76420-042-30) 76420-042-60 60 TABLET in 1 BOTTLE, PLASTIC (76420-042-60) 76420-042-90 90 TABLET in 1 BOTTLE, PLASTIC (76420-042-90)

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": "ead160e6-aba4-ca0a-e053-2a95a90ab964", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198014"], "spl_set_id": ["a4fcb411-c918-459b-adc6-06dfa8ed8a50"], "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": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET in 1 BOTTLE, PLASTIC (76420-042-01)", "package_ndc": "76420-042-01", "marketing_start_date": "20200205"}, {"sample": false, "description": "2 TABLET in 1 BOTTLE, PLASTIC (76420-042-02)", "package_ndc": "76420-042-02", "marketing_start_date": "20200205"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (76420-042-10)", "package_ndc": "76420-042-10", "marketing_start_date": "20200205"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (76420-042-14)", "package_ndc": "76420-042-14", "marketing_start_date": "20200205"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (76420-042-30)", "package_ndc": "76420-042-30", "marketing_start_date": "20200205"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (76420-042-60)", "package_ndc": "76420-042-60", "marketing_start_date": "20200205"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (76420-042-90)", "package_ndc": "76420-042-90", "marketing_start_date": "20200205"}], "brand_name": "NAPROXEN", "product_id": "76420-042_ead160e6-aba4-ca0a-e053-2a95a90ab964", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-042", "generic_name": "NAPROXEN", "labeler_name": "Asclemed USA, 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"}