ketoprofen

Generic: ketoprofen

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoprofen
Generic Name ketoprofen
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ketoprofen 200 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8200
Product ID 0378-8200_2dad8626-e0dd-46ad-9e75-069c6e82fc20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075679
Listing Expiration 2026-12-31
Marketing Start 2003-09-04

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 03788200
Hyphenated Format 0378-8200

Supplemental Identifiers

RxCUI
359697
UPC
0303788200014
UNII
90Y4QC304K
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 ketoprofen (source: ndc)
Generic Name ketoprofen (source: ndc)
Application Number ANDA075679 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)
source: ndc

Packages (1)

0378-8200-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)

Ingredients (1)

ketoprofen (200 mg/1)

Linked Drug Pages (1)

Ketoprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2dad8626-e0dd-46ad-9e75-069c6e82fc20", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0303788200014"], "unii": ["90Y4QC304K"], "rxcui": ["359697"], "spl_set_id": ["198a4140-f4c0-4478-9157-ee1d68d0bb96"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)", "package_ndc": "0378-8200-01", "marketing_start_date": "20030904"}], "brand_name": "Ketoprofen", "product_id": "0378-8200_2dad8626-e0dd-46ad-9e75-069c6e82fc20", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0378-8200", "generic_name": "ketoprofen", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoprofen", "active_ingredients": [{"name": "KETOPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA075679", "marketing_category": "ANDA", "marketing_start_date": "20030904", "listing_expiration_date": "20261231"}