Paclitaxel

Product NDC
68001-516
11-digit product format
680010516
Labeler code
68001
Product ID
68001-516_395353d9-d8e9-a4df-e063-6394a90ac9a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA213434
Marketing category
ANDA
Marketing start
2021-09-14
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-516-27Paclitaxel50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION503
68001-516-27Paclitaxel1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-516-27ML - Milliliter68001-516a5f294c5-8381-4fe5-ae82-1a8804ab623012022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-516PACLITAXEL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20240403_9e7bc2c2-a369-4c6f-9dd9-ee98ddaae833.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312199PACLitaxel 6 MG/ML Injectable SolutionPSN9e7bc2c2-a369-4c6f-9dd9-ee98ddaae8333
312199paclitaxel 6 MG/ML Injectable SolutionSCD9e7bc2c2-a369-4c6f-9dd9-ee98ddaae8333
312199paclitaxel 100 MG per 16.7 ML Injectable SolutionSY9e7bc2c2-a369-4c6f-9dd9-ee98ddaae8333
312199paclitaxel 150 MG per 25 ML Injectable SolutionSY9e7bc2c2-a369-4c6f-9dd9-ee98ddaae8333
312199paclitaxel 30 MG per 5 ML Injectable SolutionSY9e7bc2c2-a369-4c6f-9dd9-ee98ddaae8333
312199paclitaxel 300 MG per 50 ML Injectable SolutionSY9e7bc2c2-a369-4c6f-9dd9-ee98ddaae8333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-516-27680010516271 VIAL, MULTI-DOSE in 1 CARTON (68001-516-27) / 50 mL in 1 VIAL, MULTI-DOSE2021-09-140000-00-00NoNoCurrent