Docetaxel
- Product NDC
- 55150-380
- 11-digit product format
- 551500380
- Labeler code
- 55150
- Product ID
- 55150-380_5e93df13-7250-47d5-9638-0c162252aea4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA214575
- Marketing category
- ANDA
- Marketing start
- 2021-06-25
- Substance
- DOCETAXEL ANHYDROUS
- Active strength
- 10 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 ANHYDROUS | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 699121PHCA |
| Rxcui | 1093280, 1860619 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-380-01 | Docetaxel | 16 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 16 | | 2 |
| 55150-380-01 | Docetaxel | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-380 | DOCETAXEL INJECTION, SOLUTION [EUGIA US LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240712_1263799c-13dc-488b-b158-b834736a4e66.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 |
|---|
| 55150-380-01 | 55150038001 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-380-01) / 16 mL in 1 VIAL, MULTI-DOSE | 2021-06-25 | 0000-00-00 | No | No | Current |