Over-the-counter drug · OTC MONOGRAPH DRUG

MICONAZOLE Nitrate 2% (Miconazole nitrate) NDC 71399-0071

Miconazole nitrate 2 g/100g · Cream · Topical · Akron Pharma Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)71399-0071Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71399-0071Add 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
71399-0071-171399007101713990071011 TUBE in 1 BOX (71399-0071-1) / 14.2 g in 1 TUBEMarketed from Nov 19, 2024
71399-0071-371399007103713990071031 TUBE in 1 BOX (71399-0071-3) / 28.4 g in 1 TUBEMarketed from Nov 19, 2024
71399-0071-471399007104713990071041 TUBE in 1 BOX (71399-0071-4) / 42.5 g in 1 TUBEMarketed from Nov 19, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 2%
Generic name (nonproprietary)
miconazole nitrate
Active ingredients
Miconazole nitrate — 2 g/100g
Dosage form
Cream
Route
Topical
Labeler
Akron Pharma Inc.NDC labeler code 71399
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 71399-0071_b1ef7656-ad4c-4c56-987a-18628f9d9dcaSPL ID b1ef7656-ad4c-4c56-987a-18628f9d9dcaSPL set ID 8933f939-098a-4257-8d9c-4d5c3240e9a6RxCUI 998483UNII 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

N471399007101 followed by a unit qualifier and the quantity

Package 71399-0071-01. 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 proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm for effective relief of itching, scaling, cracking, burning, and discomfort

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71399-0071

What is NDC 71399-0071?
71399-0071 is the product NDC for MICONAZOLE Nitrate 2% (miconazole nitrate), Miconazole nitrate 2 g/100g cream, listed with the FDA by Akron Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
MICONAZOLE Nitrate 2% (Miconazole nitrate).
What is the active ingredient?
Miconazole nitrate.
Who is the labeler?
Akron Pharma Inc., NDC labeler code 71399. 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 2%?
1 other product NDC are listed under this name. See all MICONAZOLE Nitrate 2% 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 2% NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Miconazole Nitrate 2%jock itch sprayMiconazole nitrate 1.3 g/131gAerosol, SprayTopicalWalgreens Company0363-535300363-5353-00

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
CVS Health Athletes FoottolnaftateTolnaftate 10 mg/gCreamTopicalCVS Pharmacy, Inc.69842-336
TINGOLE FUNGAL NAIL Patchestolnaftate 1% fungal nail patchesTolnaftate 1 g/1001PatchTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-221
Wish Hand Sanitizer Coconut Cream White Floralsalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-108
Dr CANUSO fungal nail erasertolnaftate oilTolnaftate .3 g/28gOilTopicalRenu Laboratories, LLC76348-410
cmojsk TOENAIL FUNGUS PENundecylenic acid 25% tolnaftate 1% toenail fungus penTolnaftate 1 g/100mL; Undecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-220
Wish Hand Sanitizer Sweet Guava Fresh Coconutalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-106
Wish Hand Sanitizer Dragonfruit Jasminealcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-107
Hongo KillertolnaftateTolnaftate .1 g/10gAerosol, PowderTopicalEfficient Laboratories Inc58593-285
PedikleertolnaftateTolnaftate 1 g/100gCreamTopicalRising Pharma Holdings, Inc.57237-354
Athletes Footmiconazole nitrateMiconazole nitrate 20 mg/gAerosol, PowderTopicalPremier Brands of America Inc56104-912
TolnaftateTolnaftate 10 mg/gCreamTopicalSheffield Pharmaceuticals LLC11527-051
THERA Antifungal Bodymiconazole nitrateMiconazole nitrate 20 mg/gPowderTopicalMcKesson Medical-Surgical Inc.68599-0207
LMNOOP MENS Private Health Creammens private health creamOatmeal 1 g/100gCreamTopicalShenzhen Ishan Technology Co., Ltd73076-210
Hermon Jock Itch Ringworm Athletes Foot Creammiconazole nitrateMiconazole nitrate 2 g/100gCreamTopicalBeautivity LLC85398-036
Antifungal Bodymiconazole nitrateMiconazole nitrate 2 mg/100mLCreamTopicalMcKesson68599-0206
LYSSERA Fungal Nail Renewalundecylenic acid 25% antifungaUndecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-174
Anti-Fungal Powdermiconazole nitrateMiconazole nitrate 20 mg/gPowderTopicalThe Kroger Co.30142-947
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalChain Drug Marketing Association Inc.83324-329
Antifungal Medicated Body WashtolnaftateTolnaftate 1 g/100gGelTopicalRida LLC83004-012
Vamy ANTIFUNGALtolnaftate 1% antifungalTolnaftate 1 g/100mLSprayTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-176

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