63323-763 NDC - PACLITAXEL ()

Drug Information

  • Product NDC: 63323-763
  • Proprietary Name: Paclitaxel
  • Non Proprietary Name:
  • Active Ingredient(s): 6 mg/mL PACLITAXEL
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Microtubule Inhibition [PE]; Microtubule Inhibitor [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Fresenius Kabi USA, LLC
Product Type:
FDA Application Number: ANDA090130
Marketing Category: ANDA
Start Marketing Date:8/15/2014
End Marketing Date:12/22/2018

Package Information

No. Package Code Package Description Billing Unit
163323-763-051 VIAL, MULTI-DOSE in 1 CARTON (63323-763-05) / 5 mL in 1 VIAL, MULTI-DOSEML
263323-763-061 VIAL, MULTI-DOSE in 1 CARTON (63323-763-06) / 5 mL in 1 VIAL, MULTI-DOSEML
363323-763-061 VIAL, MULTI-DOSE in 1 CARTON (63323-763-06) / 5 mL in 1 VIAL, MULTI-DOSEML
463323-763-161 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16) / 16.7 mL in 1 VIAL, MULTI-DOSEML
563323-763-171 VIAL, MULTI-DOSE in 1 CARTON (63323-763-17) / 16.7 mL in 1 VIAL, MULTI-DOSEML
663323-763-171 VIAL, MULTI-DOSE in 1 CARTON (63323-763-17) / 16.7 mL in 1 VIAL, MULTI-DOSEML
763323-763-501 VIAL, MULTI-DOSE in 1 CARTON (63323-763-50) / 50 mL in 1 VIAL, MULTI-DOSEML
863323-763-521 VIAL, MULTI-DOSE in 1 CARTON (63323-763-52) / 50 mL in 1 VIAL, MULTI-DOSEML
963323-763-521 VIAL, MULTI-DOSE in 1 CARTON (63323-763-52) / 50 mL in 1 VIAL, MULTI-DOSEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC63323-763The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEPaclitaxelThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/15/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA090130This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC63323-763The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEPaclitaxelThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/15/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA090130This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC63323-763The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEPaclitaxelThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/20/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA077574This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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