ivermectin

Generic: ivermectin

Labeler: belmora llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ivermectin
Generic Name ivermectin
Labeler belmora llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

ivermectin 5 mg/g

Manufacturer
Belmora LLC

Identifiers & Regulatory

Product NDC 27854-334
Product ID 27854-334_24b0813f-ac85-aa4d-e063-6394a90a8a19
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210720
Listing Expiration 2026-12-31
Marketing Start 2024-08-12

Pharmacologic Class

Established (EPC)
antiparasitic [epc] pediculicide [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27854334
Hyphenated Format 27854-334

Supplemental Identifiers

RxCUI
1246673
UPC
0853030002915
UNII
8883YP2R6D
NUI
N0000175484 N0000181811

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 ivermectin (source: ndc)
Generic Name ivermectin (source: ndc)
Application Number ANDA210720 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (27854-334-01) / 117 g in 1 TUBE
source: ndc

Packages (1)

27854-334-01 1 TUBE in 1 CARTON (27854-334-01) / 117 g in 1 TUBE

Ingredients (1)

ivermectin (5 mg/g)

Linked Drug Pages (1)

Ivermectin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "24b0813f-ac85-aa4d-e063-6394a90a8a19", "openfda": {"nui": ["N0000175484", "N0000181811"], "upc": ["0853030002915"], "unii": ["8883YP2R6D"], "rxcui": ["1246673"], "spl_set_id": ["0d405318-3db5-41b6-a248-a6c1cfe7a765"], "pharm_class_epc": ["Antiparasitic [EPC]", "Pediculicide [EPC]"], "manufacturer_name": ["Belmora LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (27854-334-01)  / 117 g in 1 TUBE", "package_ndc": "27854-334-01", "marketing_start_date": "20240812"}], "brand_name": "Ivermectin", "product_id": "27854-334_24b0813f-ac85-aa4d-e063-6394a90a8a19", "dosage_form": "LOTION", "pharm_class": ["Antiparasitic [EPC]", "Pediculicide [EPC]"], "product_ndc": "27854-334", "generic_name": "Ivermectin", "labeler_name": "Belmora LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ivermectin", "active_ingredients": [{"name": "IVERMECTIN", "strength": "5 mg/g"}], "application_number": "ANDA210720", "marketing_category": "ANDA", "marketing_start_date": "20240812", "listing_expiration_date": "20261231"}