naproxen

Generic: naproxen

Labeler: sunrise pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler sunrise pharmaceutical, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

naproxen 500 mg/1

Manufacturer
Sunrise Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11534-212
Product ID 11534-212_502c7695-7f9d-4893-b151-65111de2e2a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091432
Listing Expiration 2026-12-31
Marketing Start 2025-12-09

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 11534212
Hyphenated Format 11534-212

Supplemental Identifiers

RxCUI
311915 603103
UPC
0311534212013 0311534211016
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

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 ANDA091432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (11534-212-01)
source: ndc

Packages (1)

11534-212-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (11534-212-01)

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": "502c7695-7f9d-4893-b151-65111de2e2a7", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0311534212013", "0311534211016"], "unii": ["57Y76R9ATQ"], "rxcui": ["311915", "603103"], "spl_set_id": ["f2fb222a-b854-4e6f-9027-2e08aed24185"], "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": ["Sunrise Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (11534-212-01)", "package_ndc": "11534-212-01", "marketing_start_date": "20251209"}], "brand_name": "Naproxen", "product_id": "11534-212_502c7695-7f9d-4893-b151-65111de2e2a7", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "11534-212", "generic_name": "Naproxen", "labeler_name": "Sunrise Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA091432", "marketing_category": "ANDA", "marketing_start_date": "20251209", "listing_expiration_date": "20261231"}