crotan

Generic: crotamiton

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

Drug Facts

Product Profile

Brand Name crotan
Generic Name crotamiton
Labeler marnel pharmaceuticals, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

crotamiton 100 mg/g

Manufacturer
Marnel Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0682-0051
Product ID 0682-0051_16625ecb-11aa-a097-e063-6294a90af3d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087204
Listing Expiration 2026-12-31
Marketing Start 2022-01-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06820051
Hyphenated Format 0682-0051

Supplemental Identifiers

RxCUI
106219 2049603
UNII
D6S4O4XD0H

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 crotan (source: ndc)
Generic Name crotamiton (source: ndc)
Application Number ANDA087204 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 237 g in 1 BOTTLE, PLASTIC (0682-0051-10)
  • 60 g in 1 BOTTLE, PLASTIC (0682-0051-20)
  • 454 g in 1 BOTTLE, PLASTIC (0682-0051-30)
source: ndc

Packages (3)

0682-0051-10 237 g in 1 BOTTLE, PLASTIC (0682-0051-10) 0682-0051-20 60 g in 1 BOTTLE, PLASTIC (0682-0051-20) 0682-0051-30 454 g in 1 BOTTLE, PLASTIC (0682-0051-30)

Ingredients (1)

crotamiton (100 mg/g)

Linked Drug Pages (1)

Crotan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "16625ecb-11aa-a097-e063-6294a90af3d5", "openfda": {"unii": ["D6S4O4XD0H"], "rxcui": ["106219", "2049603"], "spl_set_id": ["6f7478fa-ed2b-4943-9d40-1fd0161a0854"], "manufacturer_name": ["Marnel Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 g in 1 BOTTLE, PLASTIC (0682-0051-10)", "package_ndc": "0682-0051-10", "marketing_start_date": "20220115"}, {"sample": false, "description": "60 g in 1 BOTTLE, PLASTIC (0682-0051-20)", "package_ndc": "0682-0051-20", "marketing_start_date": "20220115"}, {"sample": false, "description": "454 g in 1 BOTTLE, PLASTIC (0682-0051-30)", "package_ndc": "0682-0051-30", "marketing_start_date": "20220115"}], "brand_name": "Crotan", "product_id": "0682-0051_16625ecb-11aa-a097-e063-6294a90af3d5", "dosage_form": "LOTION", "product_ndc": "0682-0051", "generic_name": "Crotamiton", "labeler_name": "Marnel Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Crotan", "active_ingredients": [{"name": "CROTAMITON", "strength": "100 mg/g"}], "application_number": "ANDA087204", "marketing_category": "ANDA", "marketing_start_date": "20220115", "listing_expiration_date": "20261231"}