Docetaxel
- Product NDC
- 46708-678
- 11-digit product format
- 467080678
- Labeler code
- 46708
- Product ID
- 46708-678_682a0b1a-3277-4718-a94e-9645633062bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA215744
- Marketing category
- ANDA
- Marketing start
- 2023-02-28
- 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 |
|---|
| 46708-678-02 | Docetaxel | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 1 |
| 46708-678-02 | Docetaxel | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 46708-678-08 | Docetaxel | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 46708-678-08 | Docetaxel | 8 mL in 1 VIAL, MULTI-DOSE | INJECTION | 8 | | 1 |
| 46708-678-16 | Docetaxel | 16 mL in 1 VIAL, MULTI-DOSE | INJECTION | 16 | | 1 |
| 46708-678-16 | Docetaxel | 1 in 1 CARTON | INJECTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-678 | DOCETAXEL INJECTION [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 6 package rows | 20230429_682a0b1a-3277-4718-a94e-9645633062bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-678-02 | 46708067802 | 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-678-02) / 2 mL in 1 VIAL, SINGLE-DOSE | 2023-02-28 | No | No | Current |
| 46708-678-08 | 46708067808 | 1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-08) / 8 mL in 1 VIAL, MULTI-DOSE | 2023-02-28 | No | No | Current |
| 46708-678-16 | 46708067816 | 1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-16) / 16 mL in 1 VIAL, MULTI-DOSE | 2023-02-28 | No | No | Current |