Docetaxel

Product NDC
67457-781
11-digit product format
674570781
Labeler code
67457
Product ID
67457-781_fea50522-6e4c-4ae0-81ac-53863693cc06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA208137
Marketing category
ANDA
Marketing start
2019-06-18
Substance
DOCETAXEL
Active strength
20 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
Docetaxel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15H5577CQD
Rxcui1001405

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be52172d-e80b-4aac-aa81-254100bce67fProduct name920260304
c4fcacbc-a699-410c-905b-642c4d134e72Product name120250616
ad3381c5-7539-4a18-83b7-e7382b118d04Product name120231117
60a22813-7270-4733-af61-30636bce9f0fProduct name420180820
0179c4ba-fb03-4931-875d-b4f1ba528029Product name120160107
9ff92ef8-2da9-4645-bbf8-642e7eb0d754Product name120150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-781-08Docetaxel1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE13
67457-781-08Docetaxel8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION, CONCENTRATE83

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-781-08ML - Milliliter67457-7817fe75c98-a624-4bd3-be5c-2388f708c80d12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-781DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]3Current NDC, Legacy NDC, 2 package rows20240302_a6417655-9448-4886-ba03-f57f36bcbd14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1001405DOCEtaxel 20 MG/ML Injectable SolutionPSNa6417655-9448-4886-ba03-f57f36bcbd143
1001405docetaxel 20 MG/ML Injectable SolutionSCDa6417655-9448-4886-ba03-f57f36bcbd143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-781-08674570781081 VIAL, MULTI-DOSE in 1 CARTON (67457-781-08) / 8 mL in 1 VIAL, MULTI-DOSE2019-06-180000-00-00NoNoCurrent