Paclitaxel

Product NDC
69339-229
11-digit product format
693390229
Labeler code
69339
Product ID
69339-229_3adcb50c-5c38-4e6b-91f9-a776b843ed47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Natco Pharma USA LLC
Application
ANDA091540
Marketing category
ANDA
Marketing start
2024-11-07
Substance
PACLITAXEL
Active strength
6 mg/mL
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
Paclitaxel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PACLITAXEL6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP88XT4IS4D
Rxcui312199

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfd8626-d4ce-43ae-acb3-8de37f80302fProduct name320260126
2cc1dc98-28db-3a82-b37e-4e50de7c4f94Product name520240102
a05831c4-07a7-44ad-9dc5-89391450ee82Product name120230323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-229-50Paclitaxel50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION503
69339-229-50Paclitaxel1 in 1 CARTONINJECTION, SOLUTION13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312199PACLitaxel 6 MG/ML Injectable SolutionPSNa1eb16b4-285b-4e81-9c4e-1244d4a52af83
312199paclitaxel 6 MG/ML Injectable SolutionSCDa1eb16b4-285b-4e81-9c4e-1244d4a52af83
312199paclitaxel 100 MG per 16.7 ML Injectable SolutionSYa1eb16b4-285b-4e81-9c4e-1244d4a52af83
312199paclitaxel 150 MG per 25 ML Injectable SolutionSYa1eb16b4-285b-4e81-9c4e-1244d4a52af83
312199paclitaxel 30 MG per 5 ML Injectable SolutionSYa1eb16b4-285b-4e81-9c4e-1244d4a52af83
312199paclitaxel 300 MG per 50 ML Injectable SolutionSYa1eb16b4-285b-4e81-9c4e-1244d4a52af83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69339-229-50693390229501 VIAL, MULTI-DOSE in 1 CARTON (69339-229-50) / 50 mL in 1 VIAL, MULTI-DOSE2024-11-07NoNoHistorical