Prescription drug · ANDA
Terconazole NDC 50090-6266
Terconazole 4 mg/g · Cream · Vaginal · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6266-0 | 50090626600 | 45 g in 1 TUBE, WITH APPLICATOR (50090-6266-0)Marketed from Dec 12, 2022 |
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)
- Terconazole
- Generic name (nonproprietary)
- terconazole
- Active ingredients
- Terconazole — 4 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076712
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 50090-6266_b7678af0-7092-4103-a9d3-5f76bd03b96bSPL ID b7678af0-7092-4103-a9d3-5f76bd03b96bSPL set ID e0a5e163-741f-4f5e-9d2e-b733f9879c99RxCUI 313226UNII 0KJ2VE664U
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450090626600followed by a unit qualifier and the quantityPackage 50090-6266-00. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076712
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Terconazole | Terconazole 4 mg/g | CreamVaginal | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0346 |
- openFDA data updated
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