Docetaxel

Product NDC
72485-216
11-digit product format
724850216
Labeler code
72485
Product ID
72485-216_10308491-d534-4e9f-9fcc-8d8a3eda213d
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
160 mg/8mL
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
60a22813-7270-4733-af61-30636bce9f0fProduct name420180820
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
0179c4ba-fb03-4931-875d-b4f1ba528029Product name120160107
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9ff92ef8-2da9-4645-bbf8-642e7eb0d754Product name120150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-216-08Docetaxel1 in 1 CARTONINJECTION11
72485-216-08Docetaxel8 mL in 1 VIAL, SINGLE-USEINJECTION81

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-216-08ML - Milliliter72485-21639655fcd-468f-4929-908f-1c7d9b5396e412020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-216DOCETAXEL INJECTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20200119_0dd863ec-f9dc-456c-9df5-4e9210d6cbb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1861411DOCEtaxel 160 MG in 8 ML InjectionPSN0dd863ec-f9dc-456c-9df5-4e9210d6cbb01
18614118 ML docetaxel 20 MG/ML InjectionSCD0dd863ec-f9dc-456c-9df5-4e9210d6cbb01
1861411docetaxel 160 MG per 8 ML InjectionSY0dd863ec-f9dc-456c-9df5-4e9210d6cbb01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72485-216-08724850216081 VIAL, SINGLE-USE in 1 CARTON (72485-216-08) / 8 mL in 1 VIAL, SINGLE-USE2020-01-150000-00-00NoNoCurrent