Docetaxel
- Product NDC
- 0143-9204
- 11-digit product format
- 001439204
- Labeler code
- 0143
- Product ID
- 0143-9204_5e524fd3-4dc2-4a16-b069-7790c57fcb72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA204490
- Marketing category
- ANDA
- Marketing start
- 2021-01-14
- 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 |
|---|
| 0143-9204-01 | Docetaxel | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 4 |
| 0143-9204-01 | Docetaxel | 1 mL in 1 VIAL, GLASS | INJECTION, SOLUTION, CONCENTRATE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9204 | DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240117_ff7fb2c2-97a7-4716-a269-925ca30cf0f1.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 |
|---|
| 0143-9204-01 | 00143920401 | 1 VIAL, GLASS in 1 CARTON (0143-9204-01) / 1 mL in 1 VIAL, GLASS | 2021-01-14 | 0000-00-00 | No | No | Current |