ABRAXANE
- Product NDC
- 68817-134
- 11-digit product format
- 688170134
- Labeler code
- 68817
- Product ID
- 68817-134_d1c7770f-7099-4ad3-84e2-20e638cb224e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paclitaxel
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Abraxis BioScience, LLC
- Application
- NDA021660
- Marketing category
- NDA
- Marketing start
- 2005-02-10
- Substance
- PACLITAXEL
- Active strength
- 100 mg/20mL
- Pharmacologic classes
- Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ABRAXANE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PACLITAXEL | 100 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P88XT4IS4D |
| Rxcui | 583214, 583218 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68817-134-50 | ABRAXANE | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 37 |
| 68817-134-50 | ABRAXANE | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 37 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68817-134 | ABRAXANE (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [ABRAXIS BIOSCIENCE, LLC] | 36 | Current NDC, Legacy NDC, 2 package rows | 20230628_24d10449-2936-4cd3-b7db-a7683db721e4.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 |
|---|
| 68817-134-50 | 68817013450 | 1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) / 20 mL in 1 VIAL, SINGLE-USE | 2005-02-10 | 0000-00-00 | No | No | Current |