Prescription drug · NDA
Terconazole Vaginal Cream 0.8% (Terconazole) NDC 0168-0347
Terconazole 8 mg/g · Cream · Vaginal · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0347-20 | 0016803472000168034720 | 20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)Marketed from Dec 1, 2020 |
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 Vaginal Cream 0.8%Suffix: Vaginal Cream 0.8%
- Generic name (nonproprietary)
- terconazole
- Active ingredients
- Terconazole — 8 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNDC labeler code 0168
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021735
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0168-0347_4b5df750-9341-4786-8e10-b0d6950f37edSPL ID 4b5df750-9341-4786-8e10-b0d6950f37edSPL set ID f59448bd-f730-46d2-a785-c2d6205579ffRxCUI 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
N400168034720followed by a unit qualifier and the quantityPackage 00168-0347-20. 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)
Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females. Terconazole Vaginal Cream is an azole antifungal indicated for the treatment of vulvovaginal candidiasis in adult females. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0168-0347
- What is NDC 0168-0347?
- 0168-0347 is the product NDC for Terconazole Vaginal Cream 0.8% (terconazole), Terconazole 8 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terconazole Vaginal Cream 0.8% (Terconazole).
- What is the active ingredient?
- Terconazole.
- Who is the labeler?
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. 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 Vaginal Cream 0.8%?
- 1 other product NDC are listed under this name. See all Terconazole Vaginal Cream 0.8% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Terconazole Vaginal Cream 0.8% 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 Vaginal Cream 0.8%terconazole | Terconazole 8 mg/g | CreamVaginal | A-S Medication Solutions | 50090-6299 | 50090-6299-00 |
Other NDCs under NDA 021735
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 Vaginal Cream 0.8%terconazole | Terconazole 8 mg/g | CreamVaginal | A-S Medication Solutions | 50090-6299 |