Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
- Product NDC
- 71288-183
- 11-digit product format
- 712880183
- Labeler code
- 71288
- Product ID
- 71288-183_ab2be690-a801-46c1-a254-213c3893fc24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paclitaxel
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA216355
- Marketing category
- ANDA
- Marketing start
- 2025-05-15
- 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 |
|---|
| 71288-183-50 | Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 71288-183-50 | Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-183 | PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (ALBUMIN-BOUND) (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [MEITHEAL PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20250524_31e893aa-8d9e-4576-8614-eb2fe772bde4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-183-50 | 71288018350 | 1 VIAL, SINGLE-USE in 1 CARTON (71288-183-50) / 20 mL in 1 VIAL, SINGLE-USE | 2025-05-15 | No | No | Current |