Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
- Product NDC
- 68001-651
- 11-digit product format
- 680010651
- Labeler code
- 68001
- Product ID
- 68001-651_3c3af5f5-c5d8-a6a1-e063-6294a90a68e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paclitaxel
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- BluePoint Laboratories
- Application
- ANDA216355
- Marketing category
- ANDA
- Marketing start
- 2025-07-18
- 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 for injectable suspension (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 |
|---|
| 68001-651-37 | Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 68001-651-37 | Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-651-37 | 68001065137 | 1 VIAL, SINGLE-USE in 1 CARTON (68001-651-37) / 20 mL in 1 VIAL, SINGLE-USE | 2025-07-18 | No | No | Current |