Prescription drug · ANDA
Terconazole NDC 51672-1330
Terconazole 80 mg/1 · Suppository · Vaginal · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1330-3 | 51672133003 | 1 DOSE PACK in 1 CARTON (51672-1330-3) / 3 SUPPOSITORY in 1 DOSE PACKMarketed from Mar 9, 2007 |
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 — 80 mg/1
- Dosage form
- Suppository
- Route
- Vaginal
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077553
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 51672-1330_3961c135-42f6-e0a2-e063-6394a90a2e33SPL ID 3961c135-42f6-e0a2-e063-6394a90a2e33SPL set ID b4f50a11-bd39-4023-9145-2da60f6b085fRxCUI 198245UNII 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
N451672133003followed by a unit qualifier and the quantityPackage 51672-1330-03. 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 Suppositories, 80 mg is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product 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 077553
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 80 mg/1 | SuppositoryVaginal | Cosette Pharmaceuticals, Inc. | 0713-0552 |