Crotan (crotamiton) NDC 0682-0051

NDC codes

FDA NDC Directory

Product NDC (as listed)0682-0051Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00682-0051Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0682-0051-10	00682005110	237 g in 1 BOTTLE, PLASTIC (0682-0051-10)Marketed from Jan 15, 2022
0682-0051-20	00682005120	60 g in 1 BOTTLE, PLASTIC (0682-0051-20)Marketed from Jan 15, 2022
0682-0051-30	00682005130	454 g in 1 BOTTLE, PLASTIC (0682-0051-30)Marketed from Jan 15, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Crotan
Generic name (nonproprietary): crotamiton
Active ingredients: Crotamiton — 100 mg/g
Dosage form: Lotion
Route: Topical
Labeler: Marnel Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 087204
Marketing start: Jan 15, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 0682-0051_16625ecb-11aa-a097-e063-6294a90af3d5SPL ID 16625ecb-11aa-a097-e063-6294a90af3d5SPL set ID 6f7478fa-ed2b-4943-9d40-1fd0161a0854RxCUI 106219, 2049603UNII D6S4O4XD0H

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400682005110 followed by a unit qualifier and the quantity

Package 00682-0051-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 18, 2024.

Indications (excerpt from the label)

CROTAN ™ (crotamiton USP 10%) is a scabicidal and antipruritic agent as a lotion for topical use only. Crotamiton is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203. 28. Crotamiton is N-ethyl-N(o-methyl-phenyl) 2-butenamide and its structural formula is: CROTAN lotion contains crotamiton USP 10% (100mg/ml) in a creamy lotion base containing purified water, light mineral oil, propylene glycol, cetearyl alcohol (and) cetearth-20, cetyl alcohol, lanolin, benzyl alcohol, carbomer 971P, sodium hydroxide with citric acid (for pH adjustment). image …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 087204

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 087204
Product	Strength	Form · route	Labeler	Product NDC
Pruradikcrotamiton	Crotamiton 100 mg/g	LotionTopical	Trifluent Pharma, LLC	73352-051