What is NDC 63347-601?

63347-601 is the product NDC for Terpenicol (undecylenic acid), Undecylenic acid 4.55 g/37.5mL cream, listed with the FDA by Blaine Labs Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Blaine Labs Inc., NDC labeler code 63347. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Terpenicol?

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.

Terpenicol NDC 63347-601 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63347-601Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63347-0601Add 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 NDC	11-digit (billing)	Package	Copy
63347-601-01	6334706010163347060101	37.5 mL in 1 BOTTLE (63347-601-01)Marketed from Jun 19, 2017

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): Terpenicol
Generic name (nonproprietary): undecylenic acid
Active ingredients: Undecylenic acid — 4.55 g/37.5mL
Dosage form: Cream
Route: Topical
Labeler: Blaine Labs Inc.NDC labeler code 63347
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 005
Marketing start: Jun 19, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 63347-601_f6a16024-2fa1-44ff-a718-af2dc7ae822eSPL ID f6a16024-2fa1-44ff-a718-af2dc7ae822eSPL set ID efd99ed1-07d3-4862-ae47-883f7d1c91c6UNII K3D86KJ24N

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

N463347060101 followed by a unit qualifier and the quantity

Package 63347-0601-01. 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 Dec 21, 2023.

Indications (excerpt from the label)

INDICATIONS: CURES ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINA CRURIS) AND RINGWORM (TINA CORPORIS). RELIEVES ITCHING, BURNING, CRACKING, SCALING, ITCHY, SCALY BETWEEN TOES AND ITCHING, BURNING FEET.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63347-601

What is NDC 63347-601?: 63347-601 is the product NDC for Terpenicol (undecylenic acid), Undecylenic acid 4.55 g/37.5mL cream, listed with the FDA by Blaine Labs Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Terpenicol (Undecylenic acid).
What is the active ingredient?: Undecylenic acid.
Who is the labeler?: Blaine Labs Inc., NDC labeler code 63347. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Terpenicol?: 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
Product	Strength	Form · route	Labeler	Product NDC
CVS Health Athletes Foottolnaftate	Tolnaftate 10 mg/g	CreamTopical	CVS Pharmacy, Inc.	69842-336
TINGOLE FUNGAL NAIL Patchestolnaftate 1% fungal nail patches	Tolnaftate 1 g/1001	PatchTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-221
Wish Hand Sanitizer Coconut Cream White Floralsalcohol hand sanitizer	Alcohol 70 mL/100mL	SprayTopical	PT SUPER HOME PRODUCT INDONESIA	85537-108
Dr CANUSO fungal nail erasertolnaftate oil	Tolnaftate .3 g/28g	OilTopical	Renu Laboratories, LLC	76348-410
cmojsk TOENAIL FUNGUS PENundecylenic acid 25% tolnaftate 1% toenail fungus pen	Tolnaftate 1 g/100mL; Undecylenic acid 25 g/100mL	LiquidTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-220
Wish Hand Sanitizer Sweet Guava Fresh Coconutalcohol hand sanitizer	Alcohol 70 mL/100mL	SprayTopical	PT SUPER HOME PRODUCT INDONESIA	85537-106
Wish Hand Sanitizer Dragonfruit Jasminealcohol hand sanitizer	Alcohol 70 mL/100mL	SprayTopical	PT SUPER HOME PRODUCT INDONESIA	85537-107
Hongo Killertolnaftate	Tolnaftate .1 g/10g	Aerosol, PowderTopical	Efficient Laboratories Inc	58593-285
Pedikleertolnaftate	Tolnaftate 1 g/100g	CreamTopical	Rising Pharma Holdings, Inc.	57237-354
Athletes Footmiconazole nitrate	Miconazole nitrate 20 mg/g	Aerosol, PowderTopical	Premier Brands of America Inc	56104-912
Tolnaftate	Tolnaftate 10 mg/g	CreamTopical	Sheffield Pharmaceuticals LLC	11527-051
THERA Antifungal Bodymiconazole nitrate	Miconazole nitrate 20 mg/g	PowderTopical	McKesson Medical-Surgical Inc.	68599-0207
LMNOOP MENS Private Health Creammens private health cream	Oatmeal 1 g/100g	CreamTopical	Shenzhen Ishan Technology Co., Ltd	73076-210
Hermon Jock Itch Ringworm Athletes Foot Creammiconazole nitrate	Miconazole nitrate 2 g/100g	CreamTopical	Beautivity LLC	85398-036
Antifungal Bodymiconazole nitrate	Miconazole nitrate 2 mg/100mL	CreamTopical	McKesson	68599-0206
LYSSERA Fungal Nail Renewalundecylenic acid 25% antifunga	Undecylenic acid 25 g/100mL	LiquidTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-174
Anti-Fungal Powdermiconazole nitrate	Miconazole nitrate 20 mg/g	PowderTopical	The Kroger Co.	30142-947
Hydrocortisone 1%hydrocortisone	Hydrocortisone 1 g/100g	CreamTopical	Chain Drug Marketing Association Inc.	83324-329
Antifungal Medicated Body Washtolnaftate	Tolnaftate 1 g/100g	GelTopical	Rida LLC	83004-012
Vamy ANTIFUNGALtolnaftate 1% antifungal	Tolnaftate 1 g/100mL	SprayTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-176

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Terpenicol (Undecylenic acid) NDC 63347-601