Docetaxel

Product NDC
72485-215
11-digit product format
724850215
Labeler code
72485
Product ID
72485-215_8c30c9d6-97ac-42b0-a5dc-97f56e94c3bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA210327
Marketing category
ANDA
Marketing start
2020-01-15
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

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
72485-215-04Docetaxel4 mL in 1 VIAL, SINGLE-USEINJECTION41
72485-215-04Docetaxel1 in 1 CARTONINJECTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-215-04ML - Milliliter72485-215e025e288-d4ae-4174-9b3d-9fecb2573fbe12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-215DOCETAXEL INJECTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20200119_7c1927a7-82ad-44ed-831e-5d4a88ac18f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860485DOCEtaxel 80 MG in 4 ML InjectionPSN7c1927a7-82ad-44ed-831e-5d4a88ac18f21
18604854 ML docetaxel 20 MG/ML InjectionSCD7c1927a7-82ad-44ed-831e-5d4a88ac18f21
1860485docetaxel 80 MG per 4 ML InjectionSY7c1927a7-82ad-44ed-831e-5d4a88ac18f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72485-215-04724850215041 VIAL, SINGLE-USE in 1 CARTON (72485-215-04) / 4 mL in 1 VIAL, SINGLE-USE2020-01-150000-00-00NoNoCurrent