Docetaxel

Product NDC
70121-1223
11-digit product format
701211223
Labeler code
70121
Product ID
70121-1223_350853a3-6178-4d83-b5c4-75b3e4c1799d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA209640
Marketing category
ANDA
Marketing start
2018-01-19
Substance
DOCETAXEL ANHYDROUS
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

Additional Listing Data#

Finished product
Yes
Brand name base
Docetaxel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL ANHYDROUS160 mg/8mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii699121PHCA
Rxcui1860480, 1860485, 1861411

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
70121-1223-1Docetaxel8 mL in 1 VIAL, GLASSINJECTION814
70121-1223-1Docetaxel1 in 1 CARTONINJECTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1223-1ML - Milliliter70121-12231e969d39-74ba-4d0f-ac00-ad04e41667fa12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1223DOCETAXEL INJECTION [AMNEAL PHARMACEUTICALS LLC]14Current NDC, Legacy NDC, 2 package rows20241122_67508df6-b96f-46fa-a792-0afcdfa9810e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1861411DOCEtaxel 160 MG in 8 ML InjectionPSN67508df6-b96f-46fa-a792-0afcdfa9810e14
1860480DOCEtaxel 20 MG in 1 ML InjectionPSN67508df6-b96f-46fa-a792-0afcdfa9810e14
1860485DOCEtaxel 80 MG in 4 ML InjectionPSN67508df6-b96f-46fa-a792-0afcdfa9810e14
18604801 ML docetaxel 20 MG/ML InjectionSCD67508df6-b96f-46fa-a792-0afcdfa9810e14
18604854 ML docetaxel 20 MG/ML InjectionSCD67508df6-b96f-46fa-a792-0afcdfa9810e14
18614118 ML docetaxel 20 MG/ML InjectionSCD67508df6-b96f-46fa-a792-0afcdfa9810e14
1861411docetaxel 160 MG per 8 ML InjectionSY67508df6-b96f-46fa-a792-0afcdfa9810e14
1860480docetaxel 20 MG per 1 ML InjectionSY67508df6-b96f-46fa-a792-0afcdfa9810e14
1860485docetaxel 80 MG per 4 ML InjectionSY67508df6-b96f-46fa-a792-0afcdfa9810e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70121-1223-1701211223011 VIAL, GLASS in 1 CARTON (70121-1223-1) / 8 mL in 1 VIAL, GLASS2018-01-190000-00-00NoNoCurrent