Over-the-counter drug · OTC MONOGRAPH DRUG

Clotrimazole (Drs. clotrimazole) NDC 80489-002

Clotrimazole 10 mg/g · Cream · Topical · OL PHARMA TECH,LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80489-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80489-0002Add 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
80489-002-0180489000201804890002011 TUBE in 1 CARTON (80489-002-01) / 28.3 g in 1 TUBEMarketed from Jan 1, 2021

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)
drs. clotrimazole
Active ingredients
Clotrimazole — 10 mg/g
Dosage form
Cream
Route
Topical
Labeler
OL PHARMA TECH,LLCNDC labeler code 80489
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 80489-002_2b522583-1d23-f3bb-e063-6394a90a76a7SPL ID 2b522583-1d23-f3bb-e063-6394a90a76a7SPL set ID b0e9fc77-6d5c-2472-e053-2995a90a3de4RxCUI 309367UNII 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 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

N480489000201 followed by a unit qualifier and the quantity

Package 80489-0002-01. 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 cures most athlete's foot, jock itch and ringworm relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80489-002

What is NDC 80489-002?
80489-002 is the product NDC for Clotrimazole (drs. clotrimazole), Clotrimazole 10 mg/g cream, listed with the FDA by OL PHARMA TECH,LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clotrimazole (Drs. Clotrimazole).
What is the active ingredient?
Clotrimazole.
Who is the labeler?
OL PHARMA TECH,LLC, NDC labeler code 80489. 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 M 005

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

FDA NDC Directory listings under M 005
ProductStrengthForm · routeLabelerProduct NDC
Lavender Foot and Shoe Antifungalundecylenic acid 10%Undecylenic acid 10 g/100mLSprayTopicalSANSAR, LLC83691-015
Sefudun Fungal Nail PatchesglycerinGlycerin .01 g/1PatchTopicalShenzhen Shandian Jingling Technology Co., Ltd.83804-006
Hongo KillertolnaftateMiconazole nitrate .2 g/10gAerosol, SprayTopicalEfficient Laboratories Inc58593-625
Lights Isopropyl Alcohol Prep Padsisopropyl alcoholIsopropyl alcohol 70 mL/100mLSolutionTopicalLights Medical Manufacture Co., Ltd.61333-206
Miconazole NitrateMiconazole nitrate 20 mg/gCreamTopicalSTRATEGIC SOURCING SERVICES LLC70677-1000
Tolnaftatemeijer athletes foot liquid sprayTolnaftate 1.5 g/150gAerosol, SprayTopicalMeijer Distribution Inc.79481-0591
Mint Blast Foot and Shoe Antifungalundecylenic acid 10%Undecylenic acid 10 g/100mLSprayTopicalSANSAR, LLC83691-013
NATURAL CURES FUNGAL NAIL Patchestolnaftate 1% fungal nail patchesTolnaftate 1 g/1001PatchTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-202
Benzo Dermabenzoic acid, salicylic acid, sulfurSalicylic acid 2.5 g/100g + 2 more ingredientsCreamTopicalLABORATORIOS H.G. C.A.84058-130
SUNMARK MICONAZOLE NITRATE antifungalmiconazole nitrateMiconazole nitrate 20 mg/gCreamTopicalStrategic Sourcing Services LLC49348-689
Hongo KillertolnaftateTolnaftate 1 g/100gPowderTopicalEfficient Laboratories Inc58593-288
Mycozyl ALtolnaftateTolnaftate .3 g/30mLLiquidTopicalPureTek Corporation59088-443
Tolnaftate Cream 1%tolnaftateTolnaftate 10 mg/gCreamTopicalPharmacy Value Alliance, LLC.68016-152
Citrus Detox Foot and Shoe Antifungalundecylenic acid 10%Undecylenic acid 10 g/100mLSprayTopicalSANSAR, LLC83691-014
Antifungal Ringworm Treatmentmiconazole nitrateMiconazole nitrate 2 g/100mLSprayTopicalRida LLC83004-030
Jock-EzeclotrimazoleClotrimazole 10 mg/gCreamTopicalBentlin Products LLC47832-071
Maximum Strength Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalWalgreens Company0363-2026
QualiLife persimmon foot and shoeundecylenic acidUndecylenic acid 10 g/100mLSprayTopicalGuangdong Aimu Biological Technology Co., Ltd83566-618
Terramed Just Think Comfort Armor Antifungal Body Wash Tea TreetolnaftateTolnaftate 1 g/100gGelTopicalRida LLC83004-032
Kakalsa TOENAIL FUNGUS TREATMENTundecylenic acid 25% toenail fungus treatmentUndecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-204

Showing 20 of 40.

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