Vagistat 3 (miconazole nitrate) NDC 11509-0081

NDC codes

FDA NDC Directory

Product NDC (as listed)11509-0081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11509-0081Add 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
11509-0081-1	11509008101	1 KIT in 1 CARTON (11509-0081-1) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBEMarketed from Mar 27, 2018

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 3
Generic name (nonproprietary): miconazole nitrate
Dosage form: Kit
Labeler: Combe Incorporated
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075329
Marketing start: Mar 27, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 11509-0081_9181ac4a-a921-4c23-a199-eb62910b33f5SPL ID 9181ac4a-a921-4c23-a199-eb62910b33f5SPL set ID e15a28cd-9e64-4e9e-8df9-829d84f1816cRxCUI 992765, 992766, 992791, 992792, 998540, 1359442

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

N411509008101 followed by a unit qualifier and the quantity

Package 11509-0081-01. 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 Nov 1, 2025.

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)

Other NDCs under ANDA 075329

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

FDA NDC Directory listings under ANDA 075329
Product	Strength	Form · route	Labeler	Product NDC
Equaline Miconazole 3miconazole nitrate	—	Kit	United Natural Foods, Inc. dba UNFI	41163-081
Good Neighbor Pharmacy Miconazole 3miconazole nitrate	—	Kit	Amerisource Bergen	24385-606
miconazole 3miconazole nitrate	—	Kit	Meijer Distribution Inc	41250-081
miconazole 3 daymiconazole nitrate	—	Kit	Publix Super Markets Inc	56062-081
topcare miconazole 3 combination packmiconazole nitrate	—	Kit	Topco Associates LLC	36800-081
Signature Care Miconazole 3miconazole nitrate	—	Kit	Safeway	21130-102
Miconazole 3miconazole nitrate	—	Kit	Safeway	21130-759
miconazole 3miconazole nitrate	—	Kit	Rite Aid Corporation	11822-0209
miconazole 3miconazole nitrate	—	Kit	Kroger Company	30142-081
dg health miconazole 3miconazole nitrate	—	Kit	Dolgencorp Inc	55910-081
Good Sense Miconazole 3miconazole nitrate	—	Kit	L. Perrigo Company	0113-0081
Foster and Thrive Miconazole 3miconazole nitrate	—	Kit	Strategic Sourcing Services LLC	70677-1226
CareOne Miconazole 3miconazole nitrate	—	Kit	American Sales Company	41520-154
Miconazole 3miconazole nitrate	—	Kit	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-689
miconazole 3miconazole nitrate	—	Kit	H E B	37808-242
Equate Miconazole 3miconazole nitrate	—	Kit	WALMART INC.	79903-241