Paclitaxel
- Product NDC
- 63323-763
- 11-digit product format
- 633230763
- Labeler code
- 63323
- Product ID
- 63323-763_11fa3178-16bd-4da3-b276-079ce8e12efb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paclitaxel
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA077574
- Marketing category
- ANDA
- Marketing start
- 2009-03-20
- Substance
- PACLITAXEL
- Active strength
- 6 mg/mL
- 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 | 6 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P88XT4IS4D |
| Rxcui | 312199 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-763-05 | Paclitaxel | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 13 |
| 63323-763-05 | Paclitaxel | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 13 |
| 63323-763-16 | Paclitaxel | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 13 |
| 63323-763-16 | Paclitaxel | 16.7 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 16.7 | | 13 |
| 63323-763-50 | Paclitaxel | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 13 |
| 63323-763-50 | Paclitaxel | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PACLITAXEL | ACTIVE INGREDIENT | P88XT4IS4D | PACLITAXEL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 6 | |
| PACLITAXEL | ACTIVE MOIETY | P88XT4IS4D | PACLITAXEL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 6 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PACLITAXEL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 6 | |
| POLYOXYL 35 CASTOR OIL | INACTIVE INGREDIENT | 6D4M1DAL6O | PACLITAXEL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-763 | PACLITAXEL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 13 | Current NDC, Legacy NDC, 6 package rows | 20241025_a6c24189-293f-42ca-b969-75870bb55af0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-763-05 | 63323076305 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-05) > 5 mL in 1 VIAL, MULTI-DOSE | 2009-03-20 | 0000-00-00 | No | No | Current |
| 63323-763-16 | 63323076316 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16) / 16.7 mL in 1 VIAL, MULTI-DOSE | 2009-03-20 | 0000-00-00 | No | No | Current |
| 63323-763-50 | 63323076350 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2009-03-20 | 0000-00-00 | No | No | Current |