Docetaxel
- Product NDC
- 23155-905
- 11-digit product format
- 231550905
- Labeler code
- 23155
- Product ID
- 23155-905_459836aa-017b-4ba5-a69d-d16824f719fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA216677
- Marketing category
- ANDA
- Marketing start
- 2024-12-15
- Substance
- DOCETAXEL
- Active strength
- 160 mg/8mL
- Pharmacologic classes
- Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Docetaxel
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCETAXEL | 160 mg/8mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 15H5577CQD |
| Rxcui | 1860480, 1860485, 1861411 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 23155-905-31 | Docetaxel | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 23155-905-31 | Docetaxel | 8 mL in 1 VIAL | INJECTION | 8 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-905 | DOCETAXEL INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20241218_81686d37-a13f-46e2-b439-a84eb1433634.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-905-31 | 23155090531 | 1 VIAL in 1 CARTON (23155-905-31) / 8 mL in 1 VIAL | 1 vial | 2024-12-15 | No | No | Current |