iwilfin

Generic: eflornithine hydrochloride

Labeler: uswm, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name iwilfin
Generic Name eflornithine hydrochloride
Labeler uswm, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

eflornithine hydrochloride 250 mg/1

Manufacturer
USWM, LLC

Identifiers & Regulatory

Product NDC 78670-150
Product ID 78670-150_49c998c7-d0b4-4527-8e34-dc5edc59a40f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215500
Listing Expiration 2026-12-31
Marketing Start 2024-01-15

Pharmacologic Class

Classes
antiprotozoal [epc] decarboxylase inhibitor [epc] decarboxylase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78670150
Hyphenated Format 78670-150

Supplemental Identifiers

RxCUI
2673199 2673205
UNII
4NH22NDW9H

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 iwilfin (source: ndc)
Generic Name eflornithine hydrochloride (source: ndc)
Application Number NDA215500 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

78670-150-01 1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE

Ingredients (1)

eflornithine hydrochloride (250 mg/1)

Linked Drug Pages (1)

iwilfin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49c998c7-d0b4-4527-8e34-dc5edc59a40f", "openfda": {"unii": ["4NH22NDW9H"], "rxcui": ["2673199", "2673205"], "spl_set_id": ["6716d8cc-66e6-4cee-935c-ccb85ed984f5"], "manufacturer_name": ["USWM, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (78670-150-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "78670-150-01", "marketing_start_date": "20240115"}], "brand_name": "iwilfin", "product_id": "78670-150_49c998c7-d0b4-4527-8e34-dc5edc59a40f", "dosage_form": "TABLET", "pharm_class": ["Antiprotozoal [EPC]", "Decarboxylase Inhibitor [EPC]", "Decarboxylase Inhibitors [MoA]"], "product_ndc": "78670-150", "generic_name": "EFLORNITHINE HYDROCHLORIDE", "labeler_name": "USWM, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "iwilfin", "active_ingredients": [{"name": "EFLORNITHINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "NDA215500", "marketing_category": "NDA", "marketing_start_date": "20240115", "listing_expiration_date": "20261231"}