DOCIVYX
- Product NDC
- 83831-102
- 11-digit product format
- 838310102
- Labeler code
- 83831
- Product ID
- 83831-102_6d914dea-626d-4402-8fce-29760fd0e34f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- docetaxel
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA215813
- Marketing category
- NDA
- Marketing start
- 2024-05-09
- Substance
- DOCETAXEL
- Active strength
- 80 mg/8mL
- Pharmacologic classes
- Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DOCIVYX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCETAXEL | 80 mg/8mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 15H5577CQD |
| Rxcui | 1860619, 2679779, 2679784, 2679786, 2679787, 2679788 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83831-102-08 | DOCIVYX | 8 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 8 | | 4 |
| 83831-102-08 | DOCIVYX | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83831-102 | DOCIVYX (DOCETAXEL) INJECTION, SOLUTION [AVYXA PHARMA, LLC] | 3 | Current NDC, 2 package rows | 20240706_4763744e-360e-4d37-be05-cce4114548cd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83831-102-08 | 83831010208 | 1 VIAL, GLASS in 1 CARTON (83831-102-08) / 8 mL in 1 VIAL, GLASS | 2024-05-09 | No | No | Current |