What is NDC 61269-220?

61269-220 is the product NDC for Clotrimazole, Clotrimazole 10 mg/g cream, listed with the FDA by H2-Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

H2-Pharma, LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clotrimazole?

63 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clotrimazole NDC 61269-220 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61269-220Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61269-0220Add 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	Copy
61269-220-41	6126902204161269022041	1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-41) / 45 g in 1 TUBE, WITH APPLICATORMarketed from Jun 29, 2021
61269-220-63	6126902206361269022063	1 TUBE, WITH APPLICATOR in 1 CARTON (61269-220-63) / 45 g in 1 TUBE, WITH APPLICATORMarketed from Jun 29, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Clotrimazole
Generic name (nonproprietary): clotrimazole
Active ingredients: Clotrimazole — 10 mg/g
Dosage form: Cream
Route: Vaginal
Labeler: H2-Pharma, LLCNDC labeler code 61269
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074165
Marketing start: Jun 29, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 61269-220_1e5b4178-017f-429d-b0d9-bc11863cd67eSPL ID 1e5b4178-017f-429d-b0d9-bc11863cd67eSPL set ID 388f7e35-efbe-496b-a8d6-518caa22328dRxCUI 309368UNII G07GZ97H65
Pharmacologic class: Azole Antifungal

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N461269022041 followed by a unit qualifier and the quantity

Package 61269-0220-41. 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 Jan 11, 2023.

Indications (excerpt from the label)

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61269-220

What is NDC 61269-220?: 61269-220 is the product NDC for Clotrimazole, Clotrimazole 10 mg/g cream, listed with the FDA by H2-Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clotrimazole.
What is the active ingredient?: Clotrimazole.
Who is the labeler?: H2-Pharma, LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clotrimazole?: 63 other product NDCs are listed under this name. See all Clotrimazole NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clotrimazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	InvaDerm Corporation	71457-523	71457-0523-1071457-0523-30
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	YYBA CORP	73581-448	73581-0448-30
Clotrimazole	Clotrimazole 1 g/100g	CreamVaginal	YYBA CORP	73581-450	73581-0450-01
Clotrimazole	Clotrimazole 100 kg/100kg	GranuleTopical	Shaanxi Shuvita Biotech Co., Ltd	87879-001	87879-0001-01
Clotrimazole	Clotrimazole 10 mg/mL	SolutionTopical	Preferred Pharmaceuticals Inc.	68788-4155	68788-4155-03
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	Preferred Pharmaceuticals Inc.	68788-4080	68788-4080-01
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	AvPAK	50268-044	50268-0044-30
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Cardinal Health (Leader) 70000	70000-0729	70000-0729-01
Clotrimazole	Clotrimazole 1 g/100g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8830	68788-8830-02
Clotrimazole	Clotrimazole 1 g/100mL	SolutionTopical	Rugby Laboratories, Inc.	0536-1443	00536-1443-70

All 64 Clotrimazole NDCs

Other NDCs under ANDA 074165

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

FDA NDC Directory listings under ANDA 074165
Product	Strength	Form · route	Labeler	Product NDC
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Walgreens	0363-0220
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Strategic Sourcing Services LLC	49348-793
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	A-S Medication Solutions	50090-7376
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Preferred Pharmaceuticals Inc.	68788-8330
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Preferred Pharmaceuticals Inc.	68788-8491
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Cardinal Health (Leader) 70000	70000-0729
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	QUALITY CHOICE (Chain Drug Marketing Association)	83324-154