Clotrimazole NDC 0574-0107

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-0107Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-0107Add 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
0574-0107-14	00574010714	140 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-14)Marketed from Dec 1, 2005
0574-0107-70	00574010770	70 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-70)Marketed from Dec 1, 2005
0574-0107-77	00574010777	70 PACKET in 1 BOX (0574-0107-77) / 1 LOZENGE in 1 PACKETMarketed from Dec 1, 2005

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
Labeler: Padagis US LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076763
Marketing start: Dec 1, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 0574-0107_c3d8e3ce-0429-4979-a91d-58dd19bbe996SPL ID c3d8e3ce-0429-4979-a91d-58dd19bbe996SPL set ID 3f57ef51-8202-4d0b-95a8-d2df468b8d9aRxCUI 309371UNII G07GZ97H65UPC 0305740107706
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

N400574010714 followed by a unit qualifier and the quantity

Package 00574-0107-14. 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 May 31, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clotrimazole lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnoses 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.

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