NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8330Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8330Add 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
68788-8330-4687888330041 TUBE, WITH APPLICATOR in 1 CARTON (68788-8330-4) / 45 g in 1 TUBE, WITH APPLICATORMarketed from Jan 20, 2023

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)
Clotrimazole
Generic name (nonproprietary)
clotrimazole
Active ingredients
Clotrimazole — 10 mg/g
Dosage form
Cream
Route
Vaginal
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074165
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 68788-8330_2acd4dac-129a-47f0-8065-2c831cbf278eSPL ID 2acd4dac-129a-47f0-8065-2c831cbf278eSPL set ID 80d67df3-843d-47bb-85a2-d2f26a824336RxCUI 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

N468788833004 followed by a unit qualifier and the quantity

Package 68788-8330-04. 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)

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
ProductStrengthForm · routeLabelerProduct NDC
ClotrimazoleClotrimazole 10 mg/gCreamVaginalPreferred Pharmaceuticals Inc.68788-8491
ClotrimazoleClotrimazole 10 mg/gCreamVaginalA-S Medication Solutions50090-7376
ClotrimazoleClotrimazole 10 mg/gCreamVaginalWalgreens0363-0220
ClotrimazoleClotrimazole 10 mg/gCreamVaginalStrategic Sourcing Services LLC49348-793
ClotrimazoleClotrimazole 10 mg/gCreamVaginalH2-Pharma, LLC61269-220
ClotrimazoleClotrimazole 10 mg/gCreamVaginalQUALITY CHOICE (Chain Drug Marketing Association)83324-154
ClotrimazoleClotrimazole 10 mg/gCreamVaginalCardinal Health (Leader) 7000070000-0729

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