What is NDC 65197-103?

65197-103 is the product NDC for Micatin (miconazole nitrate), Miconazole nitrate 20 mg/g cream, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Micatin?

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.

Micatin NDC 65197-103 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65197-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65197-0103Add 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
65197-103-05	6519701030565197010305	14 g in 1 TUBE (65197-103-05)Marketed from Jun 24, 2009

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): Micatin
Generic name (nonproprietary): miconazole nitrate
Active ingredients: Miconazole nitrate — 20 mg/g
Dosage form: Cream
Route: Topical
Labeler: WellSpring Pharmaceutical CorporationNDC labeler code 65197
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 005
Marketing start: Jun 24, 2009
Marketing end: Nov 30, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 65197-103_d9d5ec5c-ee44-42cd-9579-969f3ae1f166SPL ID d9d5ec5c-ee44-42cd-9579-969f3ae1f166SPL set ID 96c56ba1-c3a8-48ce-ab58-550959485e3cRxCUI 998483, 998509UNII 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

N465197010305 followed by a unit qualifier and the quantity

Package 65197-0103-05. 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 Apr 7, 2016.

Indications (excerpt from the label)

USES/USOS proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm / comprobado clínicamente para el tratamiento de la mayoría de los casos de pie de atleta, la sarna deportiva y la tiña for effective relief of itching, scaling, burning and discomfort that can company these conditions / Para el alivio efectivo de picazón, descamación, ardor y las molestias que pueden acompañar estas condiciones

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65197-103

What is NDC 65197-103?: 65197-103 is the product NDC for Micatin (miconazole nitrate), Miconazole nitrate 20 mg/g cream, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Micatin (Miconazole nitrate).
What is the active ingredient?: Miconazole nitrate.
Who is the labeler?: WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Micatin?: 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
Terrasil Tinea Treatment MAXclotrimazole	Clotrimazole 1 g/100g	OintmentTopical	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	24909-104
Everywhere Flushable Wipes	Benzalkonium chloride .15 U/100U	ClothTopical	Shenzhen Shierjie Biological Engineering Co., LTD	43116-042
Seacall Hydrocortisone Ointment.seacall hydrocortisone ointment	Hydrocortisone .1 g/100g	OintmentTopical	Guangdong Quadrant Ecological Technology Co., Ltd.	76986-006
Fungal Nail Nighttime Renewal Patchestolnaftate 1%	Tolnaftate 1 g/1001	PatchTopical	100 KARMA INC	85569-009
Oiangna Tea Tree Oil Antifungalclotrimazole 1%	Clotrimazole 1 g/116g	SoapTopical	Guangzhou Huixue Biotechnology Co., Ltd.	87204-285
Eyelid Wipes	4-terpineol .003 U/100U; Melaleuca alternifolia (Tea tree) leaf oil .04 U/100U	ClothTopical	Shenzhen Shierjie Biological Engineering Co., LTD	43116-040
CAREALL Clotrimazoleclotrimazole	Clotrimazole 10 g/g	CreamTopical	New World Imports, Inc	51824-063
Clotrimazole	Clotrimazole 1 g/100g	CreamTopical	Cardinal Health 110 dba LEADER	70000-0667
Gemachlich ZuHause Fungal Nail Revitalizer	Undecylenic acid 11 g/100mL	LiquidTopical	Guangdong Quadrant Ecological Technology Co., Ltd.	76986-007
Treatonic Toenail Fungus Treatment Kittoenail fungus treatment	—	KitTopical	100 KARMA INC	85569-010
Fungal Nail Treatmentglacial acetic acid	Acetic acid 10.5 g/100mL	LiquidTopical	Guchutang Biotechnology (Longyan) Co., Ltd	87083-020
Good Neighbor Pharmacy Clotrimazoleclotrimazole	Clotrimazole 10 mg/g	CreamTopical	AmerisourceBergen	24385-205
Terrasil Ringworm Treatment MAXclotrimazole	Clotrimazole 1 g/100g	OintmentTopical	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	24909-102
Clotrimazolefamily wellness clotrimazole	Clotrimazole 1 g/100g	CreamTopical	Trifecta Pharmaceuticals USA LLC	69396-038
Paume Moisturizing Antibacterial Hand Gelalcohol	Alcohol 69 mL/100mL	GelTopical	Paume Inc	80328-123
Viachs ANTIFUNGAL Creammiconazole nitrate 2% antifungal cream	Miconazole nitrate 2 g/100g	CreamTopical	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	87786-044
Clotrimazole	Clotrimazole 1 g/100g	CreamTopical	A-S Medication Solutions	50090-6546
RoyceDerm ANTIFUNGAL .soap.clotrimazole 1%	Clotrimazole 2.26 g/226g	SoapTopical	RoyceDerm LLC	85424-019
1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampoo	Ketoconazole 1 g/100mL	ShampooCutaneous	Fast Sold LLC	86241-110
Charmpoo ANTIFUNGAL BODY Creammiconazole nitrate 2% antifungal body cream	Miconazole nitrate 2 g/100g	CreamTopical	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	87786-042

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Micatin (Miconazole nitrate) NDC 65197-103