Prescription drug · NDA
Vivjoa (Oteseconazole) NDC 74695-823
Oteseconazole 150 mg/1 · Capsule · Oral · Mycovia Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 74695-823-18 | 74695082318 | 1 CONTAINER in 1 CARTON (74695-823-18) / 1 BLISTER PACK in 1 CONTAINER / 18 CAPSULE in 1 BLISTER PACKMarketed from Jul 11, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Vivjoa
- Generic name (nonproprietary)
- oteseconazole
- Active ingredients
- Oteseconazole — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mycovia Pharmaceuticals, Inc.NDC labeler code 74695
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215888
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Breast Cancer Resistance Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 74695-823_47e259e7-fa6d-849f-e063-6294a90aeba7SPL ID 47e259e7-fa6d-849f-e063-6294a90aeba7SPL set ID e21d5008-800e-4417-927f-14340341865fRxCUI 2602582, 2602588, 2605802, 2605803UNII VHH774W97N
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N474695082318followed by a unit qualifier and the quantityPackage 74695-0823-18. 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)
VIVJOA™ is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. ( 1 ) 1.1 Vulvovaginal Candidiasis VIVJOA is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) , and Clinical Studies (14) ] . 1.2 Usage If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known. However, once these results become available, antifungal ther…
Excerpt only. Read the full label for complete information.
About NDC 74695-823
- What is NDC 74695-823?
- 74695-823 is the product NDC for Vivjoa (oteseconazole), Oteseconazole 150 mg/1 capsule, listed with the FDA by Mycovia Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vivjoa (Oteseconazole).
- What is the active ingredient?
- Oteseconazole.
- Who is the labeler?
- Mycovia Pharmaceuticals, Inc., NDC labeler code 74695. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vivjoa?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.