Prescription drug · ANDA
Terconazole NDC 0713-0552
Terconazole 80 mg/1 · Suppository · Vaginal · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0552-73 | 00713055273 | 3 BLISTER PACK in 1 CARTON (0713-0552-73) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Sep 25, 2015 |
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)
- Terconazole
- Generic name (nonproprietary)
- terconazole
- Active ingredients
- Terconazole — 80 mg/1
- Dosage form
- Suppository
- Route
- Vaginal
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- 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 0713-0552_513edef8-abb4-1947-e063-6394a90af7bfSPL ID 513edef8-abb4-1947-e063-6394a90af7bfSPL set ID 38cd1718-6b3c-415d-a17f-7b399adb0ba2RxCUI 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
N400713055273followed by a unit qualifier and the quantityPackage 00713-0552-73. 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.
About NDC 0713-0552
- What is NDC 0713-0552?
- 0713-0552 is the product NDC for Terconazole, Terconazole 80 mg/1 suppository, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terconazole.
- What is the active ingredient?
- Terconazole.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Terconazole?
- 9 other product NDCs are listed under this name. See all Terconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Terconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Terconazole | Terconazole 80 mg/1 | SuppositoryVaginal | Sun Pharmaceutical Industries, Inc. | 51672-1330 | 51672-1330-03 |
| Terconazole | Terconazole 80 mg/1 | SuppositoryVaginal | Padagis Israel Pharmaceuticals Ltd | 45802-717 | 45802-0717-08 |
| Terconazole | Terconazole 4 mg/g | CreamVaginal | A-S Medication Solutions | 50090-6266 | 50090-6266-00 |
| Terconazole | Terconazole 4 mg/g | CreamVaginal | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0346 | 00168-0346-46 |
| Terconazole | Terconazole 4 mg/g | CreamVaginal | A-S Medication Solutions | 50090-0917 | 50090-0917-00 |
| Terconazole | Terconazole 4 mg/g | CreamVaginal | Sun Pharmaceutical Industries, Inc. | 51672-1304 | 51672-1304-06 |
| Terconazole | Terconazole 8 mg/g | CreamVaginal | A-S Medication Solutions | 50090-1196 | 50090-1196-00 |
| Terconazole | Terconazole 8 mg/g | CreamVaginal | NuCare Pharmaceuticals,Inc. | 68071-1626 | 68071-1626-02 |
| Terconazole | Terconazole 8 mg/g | CreamVaginal | Sun Pharmaceutical Industries, Inc. | 51672-1302 | 51672-1302-00 |
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 | Sun Pharmaceutical Industries, Inc. | 51672-1330 |