What is NDC 36800-426?

36800-426 is the product NDC for Topcare Tioconazole 1 (tioconazole), Tioconazole 6.5 g/100g ointment, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Topcare Tioconazole 1 (Tioconazole).

Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Topcare Tioconazole 1?

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.

Topcare Tioconazole 1 NDC 36800-426

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-426Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0426Add 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
36800-426-54	3680004265436800042654	1 POUCH in 1 CARTON (36800-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATORMarketed from Mar 3, 2008

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): Topcare Tioconazole 1
Generic name (nonproprietary): tioconazole
Active ingredients: Tioconazole — 6.5 g/100g
Dosage form: Ointment
Route: Vaginal
Labeler: Topco Associates LLCNDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075915
Marketing start: Mar 3, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 36800-426_d24c0ab3-4644-4b60-90a5-dc1aac6eb6f3SPL ID d24c0ab3-4644-4b60-90a5-dc1aac6eb6f3SPL set ID fce06160-2098-4ac1-9cc3-a584d4f5a51dRxCUI 198380UNII 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

N436800042654 followed by a unit qualifier and the quantity

Package 36800-0426-54. 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 Aug 8, 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 36800-426

What is NDC 36800-426?: 36800-426 is the product NDC for Topcare Tioconazole 1 (tioconazole), Tioconazole 6.5 g/100g ointment, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Topcare Tioconazole 1 (Tioconazole).
What is the active ingredient?: Tioconazole.
Who is the labeler?: Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topcare Tioconazole 1?: 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
Vagistattioconazole	Tioconazole 6.5 g/100g	OintmentVaginal	Combe Incorporated	11509-0426
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
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

Topcare Tioconazole 1 (Tioconazole) NDC 36800-426