soolantra

Generic: ivermectin

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name soolantra
Generic Name ivermectin
Labeler galderma laboratories, l.p.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ivermectin 10 mg/g

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-3823
Product ID 0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206255
Listing Expiration 2026-12-31
Marketing Start 2015-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02993823
Hyphenated Format 0299-3823

Supplemental Identifiers

RxCUI
1598068 1598073
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 soolantra (source: ndc)
Generic Name ivermectin (source: ndc)
Application Number NDA206255 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 2 g in 1 TUBE (0299-3823-00)
  • 1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0299-3823-60) / 60 g in 1 TUBE
source: ndc

Packages (5)

0299-3823-00 2 g in 1 TUBE (0299-3823-00) 0299-3823-02 1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE 0299-3823-30 1 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBE 0299-3823-45 1 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBE 0299-3823-60 1 TUBE in 1 CARTON (0299-3823-60) / 60 g in 1 TUBE

Ingredients (1)

ivermectin (10 mg/g)

Linked Drug Pages (1)

SOOLANTRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "253c7c90-5d85-b1e0-e063-6394a90a7a4b", "openfda": {"nui": ["N0000175484", "N0000181811"], "unii": ["8883YP2R6D"], "rxcui": ["1598068", "1598073"], "spl_set_id": ["b1d5b166-ab06-4ab5-b0c6-31126238118a"], "pharm_class_epc": ["Antiparasitic [EPC]", "Pediculicide [EPC]"], "manufacturer_name": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "2 g in 1 TUBE (0299-3823-00)", "package_ndc": "0299-3823-00", "marketing_start_date": "20191101"}, {"sample": true, "description": "1 TUBE in 1 BLISTER PACK (0299-3823-02)  / 2 g in 1 TUBE", "package_ndc": "0299-3823-02", "marketing_start_date": "20150101"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0299-3823-30)  / 30 g in 1 TUBE", "package_ndc": "0299-3823-30", "marketing_start_date": "20150101"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0299-3823-45)  / 45 g in 1 TUBE", "package_ndc": "0299-3823-45", "marketing_start_date": "20150101"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0299-3823-60)  / 60 g in 1 TUBE", "package_ndc": "0299-3823-60", "marketing_start_date": "20150101"}], "brand_name": "SOOLANTRA", "product_id": "0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4b", "dosage_form": "CREAM", "pharm_class": ["Antiparasitic [EPC]", "Pediculicide [EPC]"], "product_ndc": "0299-3823", "generic_name": "IVERMECTIN", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOOLANTRA", "active_ingredients": [{"name": "IVERMECTIN", "strength": "10 mg/g"}], "application_number": "NDA206255", "marketing_category": "NDA", "marketing_start_date": "20150101", "listing_expiration_date": "20261231"}