Over-the-counter drug · OTC MONOGRAPH DRUG

Miconazole Nitrate NDC 84387-003

Miconazole nitrate 20 mg/g · Ointment · Topical · ALLIED TRADE LINK LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)84387-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width84387-0003Add 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
84387-003-01843870003018438700030128.4 g in 1 TUBE (84387-003-01)Marketed from Oct 25, 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)
Miconazole Nitrate
Generic name (nonproprietary)
miconazole nitrate
Active ingredients
Miconazole nitrate — 20 mg/g
Dosage form
Ointment
Route
Topical
Labeler
ALLIED TRADE LINK LLCNDC labeler code 84387
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 84387-003_26bc78a5-3755-5f69-e063-6394a90a11a8SPL ID 26bc78a5-3755-5f69-e063-6394a90a11a8SPL set ID 25520dba-0159-2a3f-e063-6294a90a4c33UNII 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

N484387000301 followed by a unit qualifier and the quantity

Package 84387-0003-01. 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)

DIRECTIONS AND USES Uses For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for 2 weeks If condition p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 84387-003

What is NDC 84387-003?
84387-003 is the product NDC for Miconazole Nitrate, Miconazole nitrate 20 mg/g ointment, listed with the FDA by ALLIED TRADE LINK LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Miconazole Nitrate.
What is the active ingredient?
Miconazole nitrate.
Who is the labeler?
ALLIED TRADE LINK LLC, NDC labeler code 84387. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Miconazole Nitrate?
43 other product NDCs are listed under this name. See all Miconazole Nitrate 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 Miconazole Nitrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Miconazole Nitrateantifungal powder sprayMiconazole nitrate 20 mg/gAerosol, PowderTopicalPremier Brands of America Inc.56104-90756104-0907-01
Miconazole nitrateantifungal miconazole liquid continuous sprayMiconazole nitrate 20 mg/gAerosol, SprayTopicalPremier Brands of America Inc.56104-90356104-0903-01
Miconazole Nitrateanti-fungal powder miconazole nitrate talc freeMiconazole nitrate 20 mg/gPowderTopicalDiscount Drug Mart, Inc53943-97653943-0976-01
Miconazole Nitrateanti-fungal powder miconazole nitrate talc freeMiconazole nitrate 20 mg/gPowderTopicalHudson Health LLC72446-01472446-0014-01
Miconazole Nitrateathletes foot powder spray talc freeMiconazole nitrate 20 mg/gAerosol, PowderTopicalChain Drug Marketing Association83324-23383324-0233-46
Miconazole NitrateMiconazole nitrate 2 g/100gPowderTopicalAvKARE42291-93842291-0938-85
Miconazole NitrateMiconazole nitrate 20 mg/gCreamTopicalSTRATEGIC SOURCING SERVICES LLC70677-100070677-1000-01
miconazole nitrateMiconazole nitrate 20 mg/mLSolutionTopicalAvPAK50268-50350268-0503-29
Miconazole Nitrateantifungal miconazole powder sprayMiconazole nitrate 2.6 g/130gAerosol, SprayTopicalPremier Brands of America Inc.56104-12156104-0121-01
Miconazole Nitrateantifungal miconazole powder sprayMiconazole nitrate 2.6 g/130gAerosol, SprayTopicalWalgreens Company0363-741800363-7418-00

All 44 Miconazole Nitrate 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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