NDC codes

FDA NDC Directory
Product NDC (as listed)76348-410Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76348-0410Add 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
76348-410-0276348041002763480410021 BOTTLE, GLASS in 1 BOX (76348-410-02) / 14 g in 1 BOTTLE, GLASSMarketed from Aug 11, 2015

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)
Dr CANUSO fungal nail eraser
Generic name (nonproprietary)
tolnaftate oil
Active ingredients
Tolnaftate — .3 g/28g
Dosage form
Oil
Route
Topical
Labeler
Renu Laboratories, LLCNDC labeler code 76348
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Identifiers
Product ID 76348-410_350a8f7d-e332-0543-e063-6394a90a94c4SPL ID 350a8f7d-e332-0543-e063-6394a90a94c4SPL set ID 2083f9ed-09d6-26e6-e054-00144ff88e88RxCUI 1362937UNII 06KB629TKV

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

N476348041002 followed by a unit qualifier and the quantity

Package 76348-0410-02. 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 Helps cure most fungal nail and skin infections including Fungus (Tinea Pedis) Effectively relieves cracking, scaling and soreness accompanying the above conditon

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76348-410

What is NDC 76348-410?
76348-410 is the product NDC for Dr CANUSO fungal nail eraser (tolnaftate oil), Tolnaftate .3 g/28g oil, listed with the FDA by Renu Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dr CANUSO fungal nail eraser (Tolnaftate Oil).
What is the active ingredient?
Tolnaftate.
Who is the labeler?
Renu Laboratories, LLC, NDC labeler code 76348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dr CANUSO fungal nail eraser?
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
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
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
MQUPIN Liquid Fungal Nail Treatmentliquid fungal nail treatmentSalicylic acid 1 g/100mL; Chlorhexidine acetate 1 g/100mLLiquidTopicalZhengzhou Miaoqi Medical Technology Co., Ltd.83781-009

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