Docetaxel

Product NDC
43598-610
11-digit product format
435980610
Labeler code
43598
Product ID
43598-610_948f7c4c-6a40-d240-3eb3-d9ae6e371429
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA204193
Marketing category
ANDA
Marketing start
2017-08-22
Substance
DOCETAXEL
Active strength
80 mg/4mL
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
DOCETAXEL80 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15H5577CQD
Rxcui1860480, 1860485

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
43598-610-40Docetaxel4 mL in 1 VIAL, GLASSINJECTION, SOLUTION46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-610-40ML - Milliliter43598-61035f4cb01-7070-47d1-8fc7-6d6a6f6e833d12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-610DOCETAXEL INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.]6Current NDC, Legacy NDC, 1 package rows20211203_be3df07d-ea56-453a-25ad-c3cedc22712a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860480DOCEtaxel 20 MG in 1 ML InjectionPSNbe3df07d-ea56-453a-25ad-c3cedc22712a6
1860485DOCEtaxel 80 MG in 4 ML InjectionPSNbe3df07d-ea56-453a-25ad-c3cedc22712a6
18604801 ML docetaxel 20 MG/ML InjectionSCDbe3df07d-ea56-453a-25ad-c3cedc22712a6
18604854 ML docetaxel 20 MG/ML InjectionSCDbe3df07d-ea56-453a-25ad-c3cedc22712a6
1860480docetaxel 20 MG per 1 ML InjectionSYbe3df07d-ea56-453a-25ad-c3cedc22712a6
1860485docetaxel 80 MG per 4 ML InjectionSYbe3df07d-ea56-453a-25ad-c3cedc22712a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-610-40435980610404 mL in 1 VIAL, GLASS (43598-610-40) 4 ml2017-08-220000-00-00NoNoCurrent