Docetaxel
- Product NDC
- 68083-400
- 11-digit product format
- 680830400
- Labeler code
- 68083
- Product ID
- 68083-400_98672249-02db-4f71-9b49-a76e3ef56a21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA213510
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- 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 |
|---|
| 68083-400-01 | Docetaxel | 1 in 1 CARTON | INJECTION | 1 | | 6 |
| 68083-400-01 | Docetaxel | 8 mL in 1 VIAL, MULTI-DOSE | INJECTION | 8 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-400 | DOCETAXEL INJECTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20230622_14cbd8f6-e11b-4d64-aa4c-e70a2ecbf975.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 |
|---|
| 68083-400-01 | 68083040001 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-400-01) / 8 mL in 1 VIAL, MULTI-DOSE | 2021-07-01 | 0000-00-00 | No | No | Current |