NDC codes

FDA NDC Directory
Product NDC (as listed)68462-181Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0181Add 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
68462-181-176846201811715 g in 1 TUBE (68462-181-17)Marketed from Aug 4, 2010
68462-181-356846201813530 g in 1 TUBE (68462-181-35)Marketed from Aug 4, 2010
68462-181-476846201814745 g in 1 TUBE (68462-181-47)Marketed from Aug 4, 2010
68462-181-48684620181482 TUBE in 1 CARTON (68462-181-48) / 45 g in 1 TUBEMarketed from Aug 4, 2010

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)
Clotrimazole
Generic name (nonproprietary)
clotrimazole
Active ingredients
Clotrimazole — 10 mg/g
Dosage form
Cream
Route
Topical
Labeler
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090219
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 68462-181_23d83b26-b5da-4474-9468-4909134295d1SPL ID 23d83b26-b5da-4474-9468-4909134295d1SPL set ID f6898117-14f3-42d2-bc0e-d296add3ad70RxCUI 309367UNII G07GZ97H65UPC 0368462181355
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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468462018117 followed by a unit qualifier and the quantity

Package 68462-0181-17. 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)

INDICATIONS AND USAGE Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-181

What is NDC 68462-181?
68462-181 is the product NDC for Clotrimazole, Clotrimazole 10 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 4 package NDCs, 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?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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?
63 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 64 Clotrimazole NDCs

Other NDCs under ANDA 090219

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

FDA NDC Directory listings under ANDA 090219
ProductStrengthForm · routeLabelerProduct NDC
ClotrimazoleClotrimazole 10 mg/gCreamTopicalA-S Medication Solutions50090-7343
ClotrimazoleClotrimazole 10 mg/gCreamTopicalRedpharm Drug67296-2252

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