NDC codes

FDA NDC Directory
Product NDC (as listed)68788-9665Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-9665Add 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
68788-9665-4687889665041 TUBE in 1 CARTON (68788-9665-4) / 45 g in 1 TUBEMarketed from Aug 5, 2013

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 — 1 g/100g
Dosage form
Cream
Route
Vaginal
Labeler
Preferred Pharmaceuticals, Inc.NDC labeler code 68788
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 072641
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 68788-9665_61f64e2c-533a-4712-8c95-fb2fbf37c054SPL ID 61f64e2c-533a-4712-8c95-fb2fbf37c054SPL set ID 624827d6-dbf8-4f3d-a8c0-c92474cad7deRxCUI 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

N468788966504 followed by a unit qualifier and the quantity

Package 68788-9665-04. 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)

About NDC 68788-9665

What is NDC 68788-9665?
68788-9665 is the product NDC for Clotrimazole, Clotrimazole 1 g/100g cream, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clotrimazole.
What is the active ingredient?
Clotrimazole.
Who is the labeler?
Preferred Pharmaceuticals, Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clotrimazole?
64 other product NDCs are listed under this name. See all Clotrimazole NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clotrimazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ClotrimazoleClotrimazole 1 g/mLSolutionTopicalInvaDerm Corporation71457-52371457-0523-1071457-0523-30
ClotrimazoleClotrimazole 1 g/mLSolutionTopicalYYBA CORP73581-44873581-0448-30
ClotrimazoleClotrimazole 1 g/100gCreamVaginalYYBA CORP73581-45073581-0450-01
ClotrimazoleClotrimazole 100 kg/100kgGranuleTopicalShaanxi Shuvita Biotech Co., Ltd87879-00187879-0001-01
ClotrimazoleClotrimazole 10 mg/mLSolutionTopicalPreferred Pharmaceuticals Inc.68788-415568788-4155-03
ClotrimazoleClotrimazole 1 g/mLSolutionTopicalPreferred Pharmaceuticals Inc.68788-408068788-4080-01
ClotrimazoleClotrimazole 1 g/mLSolutionTopicalAvPAK50268-04450268-0044-30
ClotrimazoleClotrimazole 10 mg/gCreamVaginalCardinal Health (Leader) 7000070000-072970000-0729-01
ClotrimazoleClotrimazole 1 g/100gCreamTopicalPreferred Pharmaceuticals Inc.68788-883068788-8830-02
ClotrimazoleClotrimazole 1 g/100mLSolutionTopicalRugby Laboratories, Inc.0536-144300536-1443-70

All 65 Clotrimazole NDCs

Other NDCs under ANDA 072641

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

FDA NDC Directory listings under ANDA 072641
ProductStrengthForm · routeLabelerProduct NDC
ClotrimazoleClotrimazole 1 g/100gCreamVaginalNuCare Pharmaceuticals,Inc.68071-4026
ClotrimazoleClotrimazole 1 g/100gCreamVaginalYYBA CORP73581-450
ClotrimazoleClotrimazole 1 g/100gCreamVaginalSTRATEGIC SOURCING SERVICES LLC70677-1262
ClotrimazoleClotrimazole 1 g/100gCreamVaginalA-S Medication Solutions50090-0614
ClotrimazoleClotrimazole 1 g/100gCreamVaginalSun Pharmaceutical Industries, Inc.51672-2003

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