Paclitaxel protein-bound particles
- Product NDC
- 69097-398
- 11-digit product format
- 690970398
- Labeler code
- 69097
- Product ID
- 69097-398_7dcacda6-4a5c-4840-8f8d-cbf7b30f3415
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paclitaxel protein-bound particles
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Cipla USA Inc.
- Application
- ANDA209657
- Marketing category
- ANDA
- Marketing start
- 2025-04-15
- 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
- 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 |
|---|
| 69097-398-78 | Paclitaxel protein-bound particles | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 2 |
| 69097-398-78 | Paclitaxel protein-bound particles | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-398 | PACLITAXEL PROTEIN-BOUND PARTICLES INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [CIPLA USA INC.] | 2 | Current NDC, 2 package rows | 20250417_15eba86c-d9de-42e6-bc95-70ba4c015e72.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69097-398-78 | 69097039878 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78) / 20 mL in 1 VIAL, SINGLE-DOSE | 2025-04-15 | No | No | Current |