fenopron tm

Generic: fenoprofen calcium

Labeler: galt pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenopron tm
Generic Name fenoprofen calcium
Labeler galt pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenoprofen calcium 300 mg/1

Manufacturer
Galt Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 61825-311
Product ID 61825-311_1ad61a67-8758-4f2f-b7d5-f00f62ea69aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214475
Listing Expiration 2027-12-31
Marketing Start 2024-12-10

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61825311
Hyphenated Format 61825-311

Supplemental Identifiers

RxCUI
197695 2699827
UNII
0X2CW1QABJ

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 fenopron tm (source: ndc)
Generic Name fenoprofen calcium (source: ndc)
Application Number ANDA214475 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (61825-311-10)
source: ndc

Packages (1)

61825-311-10 100 CAPSULE in 1 BOTTLE (61825-311-10)

Ingredients (1)

fenoprofen calcium (300 mg/1)

Linked Drug Pages (1)

FENOPRON TM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ad61a67-8758-4f2f-b7d5-f00f62ea69aa", "openfda": {"unii": ["0X2CW1QABJ"], "rxcui": ["197695", "2699827"], "spl_set_id": ["2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0"], "manufacturer_name": ["Galt Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (61825-311-10)", "package_ndc": "61825-311-10", "marketing_start_date": "20241210"}], "brand_name": "FENOPRON TM", "product_id": "61825-311_1ad61a67-8758-4f2f-b7d5-f00f62ea69aa", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "61825-311", "generic_name": "FENOPROFEN CALCIUM", "labeler_name": "Galt Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOPRON", "brand_name_suffix": "TM", "active_ingredients": [{"name": "FENOPROFEN CALCIUM", "strength": "300 mg/1"}], "application_number": "ANDA214475", "marketing_category": "ANDA", "marketing_start_date": "20241210", "listing_expiration_date": "20271231"}