What is NDC 16571-686?

16571-686 is the product NDC for Clotrimazole, Clotrimazole 10 mg/1 lozenge, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 16571-686 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-686Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0686Add 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
16571-686-07	16571068607	70 LOZENGE in 1 BOTTLE (16571-686-07)Marketed from May 1, 2024
16571-686-14	16571068614	140 LOZENGE in 1 BOTTLE (16571-686-14)Marketed from May 1, 2024

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): Clotrimazole
Generic name (nonproprietary): clotrimazole
Active ingredients: Clotrimazole — 10 mg/1
Dosage form: Lozenge
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215641
Marketing start: May 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 16571-686_de2c09da-6280-4873-859a-80e779643612SPL ID de2c09da-6280-4873-859a-80e779643612SPL set ID 980736aa-751a-4642-ab85-a309435fd02fRxCUI 309371UNII G07GZ97H65
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 products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416571068607 followed by a unit qualifier and the quantity

Package 16571-0686-07. 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)

INDICATIONS AND USAGE Clotrimazole Lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole Lozenges are 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 pr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-686

What is NDC 16571-686?: 16571-686 is the product NDC for Clotrimazole, Clotrimazole 10 mg/1 lozenge, listed with the FDA by Rising Pharma Holdings, 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?: Rising Pharma Holdings, Inc., NDC labeler code 16571. 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/100g	CreamVaginal	YYBA CORP	73581-450	73581-0450-01
Clotrimazole	Clotrimazole 1 g/mL	SolutionTopical	YYBA CORP	73581-448	73581-0448-30
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