PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND
- Product NDC
- 0517-4300
- 11-digit product format
- 005174300
- Labeler code
- 0517
- Product ID
- 0517-4300_5db1c7ab-35c2-4764-b1ae-33f44560883b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paclitaxel
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- NDA211875
- Marketing category
- NDA
- Marketing start
- 2023-05-02
- Substance
- PACLITAXEL
- Active strength
- 100 mg/20mL
- 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 PROTEIN BOUND PARTICLES ALBUMIN BOUND
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PACLITAXEL | 100 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P88XT4IS4D |
| Rxcui | 583214 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-4300-01 | PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
| 0517-4300-01 | PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-4300 | PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [AMERICAN REGENT, INC.] | 4 | Current NDC, 2 package rows | 20240201_f06d1bb3-83f1-4d84-8004-4c6681ad8a5a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0517-4300-01 | 00517430001 | 1 VIAL in 1 CARTON (0517-4300-01) / 20 mL in 1 VIAL | 1 vial | 2023-05-02 | No | No | Historical |