What is NDC 85384-0002?

85384-0002 is the product NDC for Tagrit Antifungal Treament Ketoconazole 1%, Ketoconazole 10 mg/1000g cream, listed with the FDA by TAGRID LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tagrit Antifungal Treament Ketoconazole 1% (Ketoconazole).

TAGRID LLC, NDC labeler code 85384. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tagrit Antifungal Treament Ketoconazole 1%?

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.

Tagrit Antifungal Treament Ketoconazole 1% NDC 85384-0002

NDC codes

FDA NDC Directory

Product NDC (as listed)85384-0002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85384-0002Add 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
85384-0002-1	85384000201	100 g in 1 TUBE (85384-0002-1)Marketed from Apr 18, 2025

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): Tagrit Antifungal Treament Ketoconazole 1%
Generic name (nonproprietary): ketoconazole
Active ingredients: Ketoconazole — 10 mg/1000g
Dosage form: Cream
Route: Topical
Labeler: TAGRID LLCNDC labeler code 85384
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 005
Marketing start: Apr 18, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 85384-0002_a42bf040-8183-4a90-bf21-4596f5eacfc5SPL ID a42bf040-8183-4a90-bf21-4596f5eacfc5SPL set ID 315a8832-c42f-c07a-e063-6394a90a8218UNII R9400W927I
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

N485384000201 followed by a unit qualifier and the quantity

Package 85384-0002-01. 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 Mar 27, 2025.

Indications (excerpt from the label)

Treats fungal infections of the skin, such as folliculitis, athlete's foot, jock itch, ringworm, and seborrheic dermatitis. Effective for relieving symptoms of itching, scaling, redness, and discomfort caused by fungal infections. Helps reduce and control fungal skin infections, including tinea corporis (body fungus), tinea cruris (groin fungus), tinea pedis (foot fungus), and tinea versicolor. Can be used on areas prone to fungal growth, such as the scalp,face,chest, back, arms, and legs.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85384-0002

What is NDC 85384-0002?: 85384-0002 is the product NDC for Tagrit Antifungal Treament Ketoconazole 1%, Ketoconazole 10 mg/1000g cream, listed with the FDA by TAGRID LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tagrit Antifungal Treament Ketoconazole 1% (Ketoconazole).
What is the active ingredient?: Ketoconazole.
Who is the labeler?: TAGRID LLC, NDC labeler code 85384. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tagrit Antifungal Treament Ketoconazole 1%?: 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
1% ketoconazoleketoconazole	Ketoconazole 10 mg/mL	ShampooTopical	TAGRID LLC	85384-0001
1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampoo	Ketoconazole 1 g/100mL	ShampooCutaneous	Fast Sold LLC	86241-110
1236-CS Antifungal Powder (Talc Free)1236-ccantifungal powder(talc free)	Miconazole nitrate 20 mg/g	PowderTopical	Dynarex Corporation	67777-313
2% MICONAZOLE NITRATE ANTIFUNGAL Cream	Miconazole nitrate 2 g/100g	CreamTopical	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	84558-025
4ozmiconazole	Miconazole 1.2 g/120g	SoapTopical	Nabrace LLC	84056-003
5% Benzoyl Peroxide FOLLICULITIS Cream	Benzoyl peroxide 5 g/100g	CreamTopical	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	84558-026
70% Isopropyl Alcoholisopropyl alcohol	Isopropyl alcohol 70 g/100mL	LiquidTopical	IDO PHARM	77039-010
Activ-Charcoal Antifungaltolnaftate	Tolnaftate 1 g/100g	SoapTopical	HONG KONG UNORDERED TRADING CO., LIMITED	87800-0002
ADI Medical PVP-I Pouch, Foilpovidone-iodine	Povidone-iodine 10 g/100g	SolutionTopical	Asia Dynamics Inc., d/b/a ADI Medical	83645-550
Aiilo NAIL FUNGUS TREATMENTundecylenic acid 25%	Undecylenic acid .25 mg/30mL	LiquidTopical	Guangzhou Huixue Biotechnology Co., Ltd.	87204-190
Akin Anti-Fungalclotrimazole	Clotrimazole 10 mg/mL	SolutionTopical	Southern Sales & Service, Inc.	69822-254
AlphaTip Nail Repair Pennail repair pen	Undecylenic acid 20 g/100mL	LiquidTopical	Guangzhou Qiexiran Cosmetics Co., Ltd.	85817-008
Alveora FOOT ODOR PROBIOTICtolnaftate 1% foot odor probiotic	Tolnaftate 1 g/100mL	LiquidTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-030
Alveora NAIL FUNGUS TREATMENT	Tolnaftate 1 g/100mL	LiquidTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-033
Amerfresh Antibacterial Deodorantbenzethonium chloride	Benzethonium chloride .1 g/100g	SoapTopical	Liufangjing Biotechnology (Yangzhou) Co., Ltd	85420-002
Anti Dandruffketoconazole	Ketoconazole 1 g/100mL	ShampooTopical	Guangzhou ChuanMa International Trading Co.,Ltd.	85593-033
Anti- Fungal Miconazole Nitratemiconazole nitrate	Miconazole nitrate 1.42 g/71g	PowderTopical	Premier Brands of America Inc.	56104-253
Anti-Bacterial HAND SANITIZERethyl alcohol	Alcohol 63 mL/100mL	GelTopical	DISNEY DESTINATIONS,LLC	72707-029
Anti-Bacterial Wipesbenzalkonium chloride	Benzalkonium chloride .155 g/100g	SolutionTopical	Tongling Jieya Biological Technology Co., Ltd.	50552-002
Anti-Fungalmiconazole nitrate	Miconazole nitrate .02 g/g	CreamTopical	Universal Distribution Center LLC	52000-021

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Tagrit Antifungal Treament Ketoconazole 1% (Ketoconazole) NDC 85384-0002