Docetaxel
- Product NDC
- 45963-734
- 11-digit product format
- 459630734
- Labeler code
- 45963
- Product ID
- 45963-734_0bc8d3b7-f15e-4dbf-b51f-8baaa93b0e61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA203551
- Marketing category
- NDA
- Marketing start
- 2014-09-01
- Substance
- DOCETAXEL
- Active strength
- 20 mg/mL
- 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
- Docetaxel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCETAXEL | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 15H5577CQD |
| Rxcui | 1860480, 1860485 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45963-734-54 | Docetaxel | 1 mL in 1 VIAL, GLASS | INJECTION, SOLUTION, CONCENTRATE | 1 | | 52 |
| 45963-734-54 | Docetaxel | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 52 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOCETAXEL | ACTIVE INGREDIENT | 15H5577CQD | DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] | 25 | |
| DOCETAXEL ANHYDROUS | ACTIVE MOIETY | 699121PHCA | DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] | 25 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] | 25 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] | 25 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] | 25 | |
| POVIDONE K12 | INACTIVE INGREDIENT | 333AG72FWJ | DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] | 25 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-734 | DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACTAVIS PHARMA, INC.] | 52 | Current NDC, Legacy NDC, 2 package rows | 20240910_2c806400-5fdc-4398-8475-37f700b3191f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-734-54 | 45963073454 | 1 VIAL, GLASS in 1 CARTON (45963-734-54) / 1 mL in 1 VIAL, GLASS | 2014-09-01 | 0000-00-00 | No | No | Current |