Prescription drug · ANDA
Terconazole NDC 51672-1302
Terconazole 8 mg/g · Cream · Vaginal · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1302-0 | 5167213020051672130200 | 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-1302-0) / 20 g in 1 TUBE, WITH APPLICATORMarketed from Apr 6, 2004 |
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 — 8 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075953
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 51672-1302_395de373-caf5-13e9-e063-6294a90a5684SPL ID 395de373-caf5-13e9-e063-6294a90a5684SPL set ID 6d7a8fd6-7837-427e-9b18-89e33351b05eRxCUI 313227UNII 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
N451672130200followed by a unit qualifier and the quantityPackage 51672-1302-00. 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 is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 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 51672-1302
- What is NDC 51672-1302?
- 51672-1302 is the product NDC for Terconazole, Terconazole 8 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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 | Cosette Pharmaceuticals, Inc. | 0713-0552 | 00713-0552-73 |
| 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 | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0346 | 00168-0346-46 |
| Terconazole | Terconazole 4 mg/g | CreamVaginal | A-S Medication Solutions | 50090-6266 | 50090-6266-00 |
| Terconazole | Terconazole 4 mg/g | CreamVaginal | Sun Pharmaceutical Industries, Inc. | 51672-1304 | 51672-1304-06 |
| Terconazole | Terconazole 4 mg/g | CreamVaginal | A-S Medication Solutions | 50090-0917 | 50090-0917-00 |
| 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 |
Other NDCs under ANDA 075953
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 8 mg/g | CreamVaginal | A-S Medication Solutions | 50090-1196 |
| Terconazole | Terconazole 8 mg/g | CreamVaginal | NuCare Pharmaceuticals,Inc. | 68071-1626 |