What is NDC 0054-4146?

0054-4146 is the product NDC for Clotrimazole, Clotrimazole 10 mg/1 lozenge, listed with the FDA by Hikma Pharmacuticals USA USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Hikma Pharmacuticals USA USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clotrimazole?

64 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clotrimazole NDC 0054-4146 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-4146Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-4146Add 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
0054-4146-22	00054414622	70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22)Marketed from Jul 29, 2004
0054-4146-23	00054414623	140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23)Marketed from Jul 29, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Clotrimazole
Generic name (nonproprietary): clotrimazole
Active ingredients: Clotrimazole — 10 mg/1
Dosage form: Lozenge
Route: Oral, Topical
Labeler: Hikma Pharmacuticals USA USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076387
Marketing start: Jul 29, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 0054-4146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963SPL ID 3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963SPL set ID 0bc4b876-ddee-4f03-b44f-544348739a26RxCUI 309371UNII G07GZ97H65UPC 0300544146227
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. Oral, Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400054414622 followed by a unit qualifier and the quantity

Package 00054-4146-22. 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 Jul 30, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (Se…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-4146

What is NDC 0054-4146?: 0054-4146 is the product NDC for Clotrimazole, Clotrimazole 10 mg/1 lozenge, listed with the FDA by Hikma Pharmacuticals USA USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clotrimazole.
What is the active ingredient?: Clotrimazole.
Who is the labeler?: Hikma Pharmacuticals USA USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clotrimazole?: 64 other product NDCs are listed under this name. See all Clotrimazole NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clotrimazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	InvaDerm Corporation	71457-523	71457-0523-1071457-0523-30
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	YYBA CORP	73581-448	73581-0448-30
Clotrimazole	Clotrimazole 1 g/100g	CreamVaginal	YYBA CORP	73581-450	73581-0450-01
Clotrimazole	Clotrimazole 100 kg/100kg	GranuleTopical	Shaanxi Shuvita Biotech Co., Ltd	87879-001	87879-0001-01
Clotrimazole	Clotrimazole 10 mg/mL	SolutionTopical	Preferred Pharmaceuticals Inc.	68788-4155	68788-4155-03
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	Preferred Pharmaceuticals Inc.	68788-4080	68788-4080-01
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	AvPAK	50268-044	50268-0044-30
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Cardinal Health (Leader) 70000	70000-0729	70000-0729-01
Clotrimazole	Clotrimazole 1 g/100g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8830	68788-8830-02
Clotrimazole	Clotrimazole 1 g/100mL	SolutionTopical	Rugby Laboratories, Inc.	0536-1443	00536-1443-70

All 65 Clotrimazole NDCs