NDC codes

FDA NDC Directory
Product NDC (as listed)83474-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83474-0003Add 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
83474-003-34834740003341 BOTTLE, DROPPER in 1 CARTON (83474-003-34) / 10 mL in 1 BOTTLE, DROPPERMarketed from Apr 15, 2024

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 (Topical Solution), 1%
Generic name (nonproprietary)
clotrimazole
Active ingredients
Clotrimazole — 10 mg/mL
Dosage form
Solution
Route
Topical
Labeler
Puro Pharma Inc.NDC labeler code 83474
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 83474-003_46f2ddcb-401f-9ed7-e063-6394a90a7a63SPL ID 46f2ddcb-401f-9ed7-e063-6394a90a7a63SPL set ID cb424fa8-3ed5-45cd-b03f-64675584b34eRxCUI 309370UNII G07GZ97H65UPC 0383474003341
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

N483474000334 followed by a unit qualifier and the quantity

Package 83474-0003-34. 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 (tinea pedis) • Jock itch (tinea cruris) • Ringworm (tinea corporis) Effectively relieves • itching • cracking • burning • discomfort which can accompany these conditions.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83474-003

What is NDC 83474-003?
83474-003 is the product NDC for Clotrimazole (Topical Solution), 1%, Clotrimazole 10 mg/mL solution, listed with the FDA by Puro Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clotrimazole (Topical Solution), 1% (Clotrimazole).
What is the active ingredient?
Clotrimazole.
Who is the labeler?
Puro Pharma Inc., NDC labeler code 83474. 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 (Topical Solution), 1%?
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 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
1% ketoconazoleketoconazoleKetoconazole 10 mg/mLShampooTopicalTAGRID LLC85384-0001
1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampooKetoconazole 1 g/100mLShampooCutaneousFast Sold LLC86241-110
1236-CS Antifungal Powder (Talc Free)1236-ccantifungal powder(talc free)Miconazole nitrate 20 mg/gPowderTopicalDynarex Corporation67777-313
2% MICONAZOLE NITRATE ANTIFUNGAL CreamMiconazole nitrate 2 g/100gCreamTopicalGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd84558-025
4ozmiconazoleMiconazole 1.2 g/120gSoapTopicalNabrace LLC84056-003
5% Benzoyl Peroxide FOLLICULITIS CreamBenzoyl peroxide 5 g/100gCreamTopicalGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd84558-026
70% Isopropyl Alcoholisopropyl alcoholIsopropyl alcohol 70 g/100mLLiquidTopicalIDO PHARM77039-010
Activ-Charcoal AntifungaltolnaftateTolnaftate 1 g/100gSoapTopicalHONG KONG UNORDERED TRADING CO., LIMITED87800-0002
ADI Medical PVP-I Pouch, Foilpovidone-iodinePovidone-iodine 10 g/100gSolutionTopicalAsia Dynamics Inc., d/b/a ADI Medical83645-550
Aiilo NAIL FUNGUS TREATMENTundecylenic acid 25%Undecylenic acid .25 mg/30mLLiquidTopicalGuangzhou Huixue Biotechnology Co., Ltd.87204-190
Akin Anti-FungalclotrimazoleClotrimazole 10 mg/mLSolutionTopicalSouthern Sales & Service, Inc.69822-254
AlphaTip Nail Repair Pennail repair penUndecylenic acid 20 g/100mLLiquidTopicalGuangzhou Qiexiran Cosmetics Co., Ltd.85817-008
Alveora FOOT ODOR PROBIOTICtolnaftate 1% foot odor probioticTolnaftate 1 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-030
Alveora NAIL FUNGUS TREATMENTTolnaftate 1 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-033
Amerfresh Antibacterial Deodorantbenzethonium chlorideBenzethonium chloride .1 g/100gSoapTopicalLiufangjing Biotechnology (Yangzhou) Co., Ltd85420-002
Anti DandruffketoconazoleKetoconazole 1 g/100mLShampooTopicalGuangzhou ChuanMa International Trading Co.,Ltd.85593-033
Anti- Fungal Miconazole Nitratemiconazole nitrateMiconazole nitrate 1.42 g/71gPowderTopicalPremier Brands of America Inc.56104-253
Anti-Bacterial HAND SANITIZERethyl alcoholAlcohol 63 mL/100mLGelTopicalDISNEY DESTINATIONS,LLC72707-029
Anti-Bacterial Wipesbenzalkonium chlorideBenzalkonium chloride .155 g/100gSolutionTopicalTongling Jieya Biological Technology Co., Ltd.50552-002
Anti-Fungalmiconazole nitrateMiconazole nitrate .02 g/gCreamTopicalUniversal Distribution Center LLC52000-021

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