Docetaxel
- Product NDC
- 62332-678
- 11-digit product format
- 623320678
- Labeler code
- 62332
- Product ID
- 62332-678_59e116c8-6ba0-4459-b71b-75ad9492ff14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Docetaxel
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Alembic Pharmaceuticals Inc.
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-678 | DOCETAXEL INJECTION [ALEMBIC PHARMACEUTICALS INC.] | 11 | Current NDC, 6 package rows | 20230905_3a49c281-8cfd-4698-a9df-90ba800058ef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-678-02 | 62332067802 | 1 VIAL, SINGLE-DOSE in 1 CARTON (62332-678-02) / 2 mL in 1 VIAL, SINGLE-DOSE | 2023-02-28 | No | No | Current |
| 62332-678-08 | 62332067808 | 1 VIAL, MULTI-DOSE in 1 CARTON (62332-678-08) / 8 mL in 1 VIAL, MULTI-DOSE | 2023-02-28 | No | No | Current |
| 62332-678-16 | 62332067816 | 1 VIAL, MULTI-DOSE in 1 CARTON (62332-678-16) / 16 mL in 1 VIAL, MULTI-DOSE | 2023-02-28 | No | No | Current |