Over-the-counter drug · OTC MONOGRAPH DRUG

Medline (Miconazole nitrate) NDC 53329-218

Miconazole nitrate 20 mg/100g · Cream · Topical · Medline Industries, LP

NDC codes

FDA NDC Directory
Product NDC (as listed)53329-218Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0218Add 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
53329-218-445332902184453329021844113 g in 1 TUBE (53329-218-44)Marketed from Oct 1, 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)
Medline
Generic name (nonproprietary)
miconazole nitrate
Active ingredients
Miconazole nitrate — 20 mg/100g
Dosage form
Cream
Route
Topical
Labeler
Medline Industries, LPNDC labeler code 53329
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 53329-218_42f3af59-a020-421e-e063-6294a90a6eabSPL ID 42f3af59-a020-421e-e063-6294a90a6eabSPL set ID 1ea444eb-f2f5-8c63-e063-6294a90acac8UNII 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

N453329021844 followed by a unit qualifier and the quantity

Package 53329-0218-44. 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 most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53329-218

What is NDC 53329-218?
53329-218 is the product NDC for Medline (miconazole nitrate), Miconazole nitrate 20 mg/100g cream, listed with the FDA by Medline Industries, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Medline (Miconazole nitrate).
What is the active ingredient?
Miconazole nitrate.
Who is the labeler?
Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Medline?
46 other product NDCs are listed under this name. See all Medline 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 Medline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MedlineacetaminophenAcetaminophen 325 mg/1TabletOralMedline Industries, LP53329-19953329-0199-09
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-22153329-0221-09
MedlineiburprofenIbuprofen 200 mg/1Tablet, Film coatedOralMedline Industries, LP53329-60353329-0603-09
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60553329-0605-09
Medlinemiconazole nitrateMiconazole nitrate 20 mg/gOintmentTopicalMedline Industries, LP53329-25653329-0256-1453329-0256-64
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60453329-0604-30
MedlinedimethiconeDimethicone 1.575 g/100mLCreamTopicalMedline Industries, LP53329-27153329-0271-4453329-0271-86
MedlineaspirinAspirin 81 mg/1Tablet, Delayed releaseOralMedline Industries, LP53329-60053329-0600-67
Medlinewhite petrolatumWhite petrolatum 86.5 g/100gOintmentTopicalMedline Industries, LP53329-25753329-0257-1053329-0257-74
Medlinezinc oxideZinc oxide 200 mg/gPasteTopicalMedline Industries, LP53329-25553329-0255-0553329-0255-10

All 47 Medline 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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