Over-the-counter drug · ANDA

vagisil brand vagistat (Miconazole nitrate) NDC 11509-0825

Miconazole nitrate 2 g/100g · Cream · Vaginal · Combe Incorporated

NDC codes

FDA NDC Directory
Product NDC (as listed)11509-0825Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11509-0825Add 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 NDC11-digit (billing)PackageCopy
11509-0825-111509082501115090825011 TUBE in 1 CARTON (11509-0825-1) / 45 g in 1 TUBEMarketed from Oct 8, 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)
vagisil brand vagistat
Generic name (nonproprietary)
miconazole nitrate
Active ingredients
Miconazole nitrate — 2 g/100g
Dosage form
Cream
Route
Vaginal
Labeler
Combe IncorporatedNDC labeler code 11509
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074760
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 11509-0825_42a55863-e89f-4ec0-97a0-2d7b1e2b6b36SPL ID 42a55863-e89f-4ec0-97a0-2d7b1e2b6b36SPL set ID 833a5e4d-0591-4300-8f9c-fd00ffaf6041RxCUI 998540, 1359442UNII VW4H1CYW1K
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

N411509082501 followed by a unit qualifier and the quantity

Package 11509-0825-01. 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 .

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 11509-0825

What is NDC 11509-0825?
11509-0825 is the product NDC for vagisil brand vagistat (miconazole nitrate), Miconazole nitrate 2 g/100g cream, 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?
vagisil brand vagistat (Miconazole nitrate).
What is the active ingredient?
Miconazole nitrate.
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 vagisil brand 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 074760

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

FDA NDC Directory listings under ANDA 074760
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalAmazon.com Services LLC72288-825
Careone miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalAmerican Sales Company41520-825
DG Health Miconazolemiconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalDolgencorp Inc55910-698
Equaline Miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalUnited Natural Foods, Inc. dba UNFI41163-825
foster and thrive miconazolemiconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalStrategic Sourcing Services LLC70677-1222
foster and thrive miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalStrategic Sourcing Services LLC70677-1225
Good Neighbor Pharmacy Miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalAmerisource Bergen24385-590
Good Sense Miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalL Perrigo Company0113-0214
good sense miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalL. Perrigo Company0113-0825
good sense miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalPreferred Pharmaceuticals Inc.68788-4117
Miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalSafeway21130-696
Miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalKroger Company30142-825
miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalH E B37808-825
Miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalMeijer Distribution Inc41250-825
miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalHyVee Inc42507-769
signature care miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalSafeway21130-825
Topcare Miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalTopco Associates LLC36800-825
up and up miconazole 7miconazole nitrateMiconazole nitrate 2 g/100gCreamVaginalTarget Corporation11673-825

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