What is NDC 85384-0001?

85384-0001 is the product NDC for 1% ketoconazole (ketoconazole), Ketoconazole 10 mg/mL shampoo, 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?

1% ketoconazole (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 1% ketoconazole?

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.

1% ketoconazole NDC 85384-0001-1 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85384-0001Labeler and product segments. Claims need a package NDC.

Package you searched · 11-digit85384-0001-01From 85384-0001-1

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
85384-0001-1Searched	85384000101	250 mL in 1 BOTTLE (85384-0001-1)Marketed from Mar 31, 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): 1% ketoconazole
Generic name (nonproprietary): ketoconazole
Active ingredients: Ketoconazole — 10 mg/mL
Dosage form: Shampoo
Route: Topical
Labeler: TAGRID LLCNDC labeler code 85384
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 005
Marketing start: Mar 31, 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 85384-0001_1b9d0aa4-ace1-48b8-a76f-ddf34c238320SPL ID 1b9d0aa4-ace1-48b8-a76f-ddf34c238320SPL set ID 30b75584-3a1e-c125-e063-6294a90acaa7RxCUI 240812UNII 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

N485384000101 followed by a unit qualifier and the quantity

Package 85384-0001-01. 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 19, 2025.

Indications (excerpt from the label)

Targets Stubborn Dandruff, Seborrheic Dermatitis, and itching Prevention, Treatment, and control of fungus that can cause dandruff

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85384-0001

What is NDC 85384-0001?: 85384-0001 is the product NDC for 1% ketoconazole (ketoconazole), Ketoconazole 10 mg/mL shampoo, 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?: 1% ketoconazole (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 1% ketoconazole?: 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% 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
Anti-Fungal Powdermiconazole nitrate	Miconazole nitrate 20 mg/g	PowderTopical	The Kroger Co.	30142-947

Showing 20 of 39.

1% ketoconazole (Ketoconazole) NDC 85384-0001