Paclitaxel

Product NDC
45963-613
11-digit product format
459630613
Labeler code
45963
Product ID
45963-613_eed2dd59-d294-4bff-af95-8408494970c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Actavis Pharma, Inc.
Application
ANDA090130
Marketing category
ANDA
Marketing start
2018-06-13
Marketing end
2021-08-31
Substance
PACLITAXEL
Active strength
6 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-613-53ML - Milliliter45963-6136306e25c-f807-4ca9-ab3b-a2edefbfc86112015-02-02
45963-613-56ML - Milliliter45963-6132c9e6279-ac95-49db-b1c1-7fe301bdc78112015-02-02
45963-613-59ML - Milliliter45963-6131b47a3bc-ec57-4471-9c5c-748285ef798812015-02-02
45963-613-83ML - Milliliter45963-613a71c819a-9ad6-467c-83a1-893558d186b812018-08-13
45963-613-86ML - Milliliter45963-6137c92df6a-276f-436a-be14-9d786ae90b5e12018-07-03
45963-613-89ML - Milliliter45963-613989ac00d-7f28-45fe-8625-121d1da42b1412018-07-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-613-53459630613531 VIAL, MULTI-DOSE in 1 CARTON (45963-613-53) > 16.7 mL in 1 VIAL, MULTI-DOSE2018-07-192022-07-31NoNoCurrent
45963-613-56459630613561 VIAL, MULTI-DOSE in 1 CARTON (45963-613-56) > 5 mL in 1 VIAL, MULTI-DOSE2018-07-192021-04-30NoNoCurrent
45963-613-59459630613591 VIAL, MULTI-DOSE in 1 CARTON (45963-613-59) > 50 mL in 1 VIAL, MULTI-DOSE2018-07-192022-06-30NoNoCurrent
45963-613-83459630613831 VIAL, MULTI-DOSE in 1 CARTON (45963-613-83) > 16.7 mL in 1 VIAL, MULTI-DOSE2018-06-132021-04-30NoNoCurrent
45963-613-86459630613861 VIAL, MULTI-DOSE in 1 CARTON (45963-613-86) > 5 mL in 1 VIAL, MULTI-DOSE2018-06-132021-03-31NoNoCurrent
45963-613-89459630613891 VIAL, MULTI-DOSE in 1 CARTON (45963-613-89) > 50 mL in 1 VIAL, MULTI-DOSE2018-06-132021-08-31NoNoCurrent