Paclitaxel

Product NDC
16729-098
11-digit product format
167290098
Labeler code
16729
Product ID
16729-098_c12ad367-5f50-5668-e053-2995a90a04e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PACLITAXEL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA205720
Marketing category
ANDA
Marketing start
2022-06-15
Marketing end
0000-00-00
Substance
PACLITAXEL
Active strength
6 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-098PACLITAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]3Legacy NDC20220615_30ad282b-def4-4269-8a53-a0485d15557a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-098-05167290098051 VIAL, MULTI-DOSE in 1 CARTON (16729-098-05) > 16.7 mL in 1 VIAL, MULTI-DOSE2022-06-150000-00-00NoNoCurrent
16729-098-11167290098111 VIAL, MULTI-DOSE in 1 CARTON (16729-098-11) > 50 mL in 1 VIAL, MULTI-DOSE2022-06-150000-00-00NoNoCurrent
16729-098-31167290098311 VIAL, MULTI-DOSE in 1 CARTON (16729-098-31) > 5 mL in 1 VIAL, MULTI-DOSE2022-06-150000-00-00NoNoCurrent