What is NDC 11509-0426?

11509-0426 is the product NDC for Vagistat (tioconazole), Tioconazole 6.5 g/100g ointment, listed with the FDA by Combe Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.

Combe Incorporated, NDC labeler code 11509. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Vagistat?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Vagistat NDC 11509-0426 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)11509-0426Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11509-0426Add 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
11509-0426-1	1150904260111509042601	1 POUCH in 1 CARTON (11509-0426-1) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATORMarketed from Jul 29, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Vagistat
Generic name (nonproprietary): tioconazole
Active ingredients: Tioconazole — 6.5 g/100g
Dosage form: Ointment
Route: Vaginal
Labeler: Combe IncorporatedNDC labeler code 11509
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075915
Marketing start: Jul 29, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 11509-0426_8c436269-2f52-4ddf-b3be-cec3069a8865SPL ID 8c436269-2f52-4ddf-b3be-cec3069a8865SPL set ID da8eaa33-4195-487f-a234-472dd1036225RxCUI 198380, 1550534UNII S57Y5X1117
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

N411509042601 followed by a unit qualifier and the quantity

Package 11509-0426-01. 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 Jun 22, 2024.

Indications (excerpt from the label)

Use • treats vaginal yeast infections

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11509-0426

What is NDC 11509-0426?: 11509-0426 is the product NDC for Vagistat (tioconazole), Tioconazole 6.5 g/100g ointment, listed with the FDA by Combe Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Vagistat (Tioconazole).
What is the active ingredient?: Tioconazole.
Who is the labeler?: Combe Incorporated, NDC labeler code 11509. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Vagistat?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 075915

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

FDA NDC Directory listings under ANDA 075915
Product	Strength	Form · route	Labeler	Product NDC
foster and thrive tioconazoletioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Strategic Sourcing Services LLC	70677-1224
signature care tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Safeway	21130-060
Tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Safeway	21130-781
tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Meijer Distribution Inc	41250-426
Up and up tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Target Corporation	11673-426
basic care tioconazoletioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Amazon.com Services LLC	72288-426
Monistat Tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentTopical	Insight Pharmaceuticals LLC	63736-413
tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	CVS Pharmacy	59779-718
good sense tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	L. Perrigo Company	0113-0426
CareOne Tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	American Sales Company	41520-426
Topcare Tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Topco Associates LLC	36800-426
dg health tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Dolgencorp Inc	55910-731
Equate tioconazole 1 daytioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Wal-Mart Stores Inc	49035-426
Tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Walgreen Company	0363-0426
Leader Tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Cardinal Health 110, LLC. dba Leader	70000-0357
Tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Amazon.com Services LLC	72288-222
Tioconazole 1tioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	H E B	37808-426

Vagistat (Tioconazole) NDC 11509-0426