Over-the-counter drug · OTC MONOGRAPH DRUG

Triple Antifungal (miconazole nitrate) NDC 16864-040

Miconazole nitrate 2 g/100g · Ointment · Topical · Advantice Health, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)16864-040Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16864-0040Add 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
16864-040-02168640040021 TUBE in 1 CARTON (16864-040-02) / 56.7 g in 1 TUBEMarketed from Sep 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)
Triple Antifungal
Generic name (nonproprietary)
miconazole nitrate
Active ingredients
Miconazole nitrate — 2 g/100g
Dosage form
Ointment
Route
Topical
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 16864-040_4d63f2a2-f113-d739-e063-6394a90a2d27SPL ID 4d63f2a2-f113-d739-e063-6394a90a2d27SPL set ID 9a47fb1b-a41f-4c8a-8e43-7332853c308eRxCUI 998442, 998460UNII VW4H1CYW1K
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

N416864004002 followed by a unit qualifier and the quantity

Package 16864-0040-02. 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 For the treatment of superficial skin infections caused by yeast (Candida albicans) Relieves discomfort, irrit.ation, redness and chafing associated with jock itch Cures most jock itch (tinea cruris)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
Molecular AFtolnaftateTolnaftate .01 mg/mLOilTopicalRenu Laboratories, LLC76348-401
SimplyVital Antifungal ClotrimazoleclotrimazoleClotrimazole 10 mg/mLCreamTopicalAlpha Plants Inc82460-990
Sovs Fungal Nail Repair Renewalundecylenic acid 25% fungal nail repair renewalUndecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-232
WISH HAND SANITIZER Lychee Vanilla Milkalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-208
ClotrimazoleClotrimazole 10 mg/gCreamTopicalWalgreen Company0363-2105
BODYKOO JOCK ITCH Creamclotrimazole1% jock itch creamClotrimazole 1 g/100gCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-228
WISH HAND SANITIZER Strawberry Muskalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-205
HSENJT Antifungal Creammiconazole nitrateMiconazole nitrate 20 mg/gCreamTopicalHuizhou Haosen Trading Co., Ltd.87951-001
Hongo Killerundecylenic acidUndecylenic acid 2 mg/10mLSprayTopicalEfficient Laboratories Inc58593-601
SIMPLY VITAL Antifungal CreamclotrimazoleClotrimazole 10 mg/mLCreamTopicalALPHA PLANTS INC82460-344
BODYKOO ATHLETE FOOT Creammiconazole nitrate2% athlete foot creamMiconazole nitrate 2 g/100gCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-229
WISH HAND SANITIZER Sea Salt Green Herbsalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-206
Nail Renovar PlustolnaftateTolnaftate 1 g/100mLLiquidTopicalSOHM, Inc50405-030
Hongo KillertolnaftateMiconazole nitrate .2 g/10gAerosol, SprayTopicalEfficient Laboratories Inc58593-625
Miconazole Nitrateathletes foot liquidMiconazole nitrate 3 g/150gSprayTopicalWalgreens Company0363-4208
Fitcube NAIL REPAIR PENundecylenic acid 25% tolnaftate 1% nail repair penUndecylenic acid 25 g/100mL; Tolnaftate 1 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-230
WISH HAND SANITIZER Marshmallow Vanillaalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-207
Recuren Plus Jock Itch Creammiconazole nitrate 2%Miconazole nitrate 20 mg/gCreamTopicalREGENEREN PLUS LTD87014-004
Lightning X Hand Cleanserethyl alcoholAlcohol 62 mL/100mLGelTopicalNantong Health & Beyond Hygienic Products Inc.43473-122
Tolnaftatemeijer athletes foot liquid sprayTolnaftate 1.5 g/150gAerosol, SprayTopicalMeijer Distribution Inc.79481-0591

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