Paclitaxel

Product NDC
62332-620
11-digit product format
623320620
Labeler code
62332
Product ID
62332-620_9a4e25af-2c07-46c8-a9f2-28ba744c8117
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA216874
Marketing category
ANDA
Marketing start
2022-10-20
Substance
PACLITAXEL
Active strength
6 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paclitaxel
Listing expiration
2026-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-620-05Paclitaxel5 mL in 1 VIAL, MULTI-DOSEINJECTION54
62332-620-05Paclitaxel1 in 1 CARTONINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-620-05ML - Milliliter62332-620403d8214-5f74-4b8e-b6da-333fc7a2e03512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-620PACLITAXEL INJECTION [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240625_0c12c77c-5fd4-48dc-a318-e96892233992.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312199PACLitaxel 6 MG/ML Injectable SolutionPSN0c12c77c-5fd4-48dc-a318-e968922339924
312199paclitaxel 6 MG/ML Injectable SolutionSCD0c12c77c-5fd4-48dc-a318-e968922339924
312199paclitaxel 100 MG per 16.7 ML Injectable SolutionSY0c12c77c-5fd4-48dc-a318-e968922339924
312199paclitaxel 150 MG per 25 ML Injectable SolutionSY0c12c77c-5fd4-48dc-a318-e968922339924
312199paclitaxel 30 MG per 5 ML Injectable SolutionSY0c12c77c-5fd4-48dc-a318-e968922339924
312199paclitaxel 300 MG per 50 ML Injectable SolutionSY0c12c77c-5fd4-48dc-a318-e968922339924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-620-05623320620051 VIAL, MULTI-DOSE in 1 CARTON (62332-620-05) / 5 mL in 1 VIAL, MULTI-DOSE2022-10-200000-00-00NoNoCurrent