Paclitaxel
- Product NDC
- 0781-3531
- 11-digit product format
- 007813531
- Labeler code
- 0781
- Product ID
- 0781-3531_374cacf2-c5ef-4958-e063-6294a90a5b3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paclitaxel
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- ANDA212700
- Marketing category
- ANDA
- Marketing start
- 2024-10-08
- 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
- 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 |
|---|
| 0781-3531-91 | Paclitaxel | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 0781-3531-91 | Paclitaxel | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3531 | PACLITAXEL INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [SANDOZ INC] | 3 | Current NDC, 2 package rows | 20250527_15ca4829-8fee-45f9-b4bc-b31c15732cd6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0781-3531-91 | 00781353191 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3531-91) / 20 mL in 1 VIAL, SINGLE-DOSE | 2024-10-09 | No | No | Current |