Paclitaxel
- Product NDC
- 46708-621
- 11-digit product format
- 467080621
- Labeler code
- 46708
- Product ID
- 46708-621_6d04b514-c85c-4db1-919e-21dd98172791
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paclitaxel
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA216874
- Marketing category
- ANDA
- Marketing start
- 2022-10-20
- Substance
- PACLITAXEL
- Active strength
- 6 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
- Paclitaxel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PACLITAXEL | 6 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P88XT4IS4D |
| Rxcui | 312199 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-621-17 | Paclitaxel | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 46708-621-17 | Paclitaxel | 16.7 mL in 1 VIAL, MULTI-DOSE | INJECTION | 16.7 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-621 | PACLITAXEL INJECTION [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20230201_6d04b514-c85c-4db1-919e-21dd98172791.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-621-17 | 46708062117 | 1 VIAL, MULTI-DOSE in 1 CARTON (46708-621-17) / 16.7 mL in 1 VIAL, MULTI-DOSE | 2022-10-20 | No | No | Current |