naproxen

Generic: naproxen

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

Drug Facts

Product Profile

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

naproxen 500 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-855
Product ID 69097-855_598c64ad-f0c4-495e-b2c2-cde215d2572d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091305
Listing Expiration 2026-12-31
Marketing Start 2016-07-05

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 69097855
Hyphenated Format 69097-855

Supplemental Identifiers

RxCUI
198012 198013 198014
UPC
0369097855079 0369097854072 0369097853075
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 ANDA091305 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69097-855-07)
  • 500 TABLET in 1 BOTTLE (69097-855-12)
source: ndc

Packages (2)

69097-855-07 100 TABLET in 1 BOTTLE (69097-855-07) 69097-855-12 500 TABLET in 1 BOTTLE (69097-855-12)

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": "598c64ad-f0c4-495e-b2c2-cde215d2572d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0369097855079", "0369097854072", "0369097853075"], "unii": ["57Y76R9ATQ"], "rxcui": ["198012", "198013", "198014"], "spl_set_id": ["a9549a47-3fa4-4a2b-95ac-b00e43aedae7"], "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": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-855-07)", "package_ndc": "69097-855-07", "marketing_start_date": "20160705"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69097-855-12)", "package_ndc": "69097-855-12", "marketing_start_date": "20160705"}], "brand_name": "naproxen", "product_id": "69097-855_598c64ad-f0c4-495e-b2c2-cde215d2572d", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69097-855", "generic_name": "naproxen", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "naproxen", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA091305", "marketing_category": "ANDA", "marketing_start_date": "20160705", "listing_expiration_date": "20261231"}