Docetaxel anhydrous

Product NDC
71288-144
11-digit product format
712880144
Labeler code
71288
Product ID
71288-144_77b41d41-9975-428a-865a-1593d21b3d99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel anhydrous
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc
Application
ANDA209634
Marketing category
ANDA
Marketing start
2018-08-24
Substance
DOCETAXEL ANHYDROUS
Active strength
10 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 anhydrous
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii699121PHCA
Rxcui1093280

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
71288-144-08Docetaxel anhydrous1 in 1 CARTONINJECTION, SOLUTION14
71288-144-08Docetaxel anhydrous8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION84
71288-144-16Docetaxel anhydrous1 in 1 CARTONINJECTION, SOLUTION14
71288-144-16Docetaxel anhydrous16 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION164

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-144-08ML - Milliliter71288-1447a74bb4e-7cc1-4007-86de-3cac09a7c5c612023-02-06
71288-144-16ML - Milliliter71288-144f56cdeda-9abc-4271-9ff2-17a5f7f479be12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-144DOCETAXEL ANHYDROUS INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 4 package rows20230818_9fb533da-a7ba-4c2b-8e4f-8e336ba55d12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093280DOCEtaxel 10 MG/ML Injectable SolutionPSN9fb533da-a7ba-4c2b-8e4f-8e336ba55d124
1093280docetaxel 10 MG/ML Injectable SolutionSCD9fb533da-a7ba-4c2b-8e4f-8e336ba55d124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-144-08712880144081 VIAL, MULTI-DOSE in 1 CARTON (71288-144-08) / 8 mL in 1 VIAL, MULTI-DOSE2018-08-240000-00-00NoNoCurrent
71288-144-16712880144161 VIAL, MULTI-DOSE in 1 CARTON (71288-144-16) / 16 mL in 1 VIAL, MULTI-DOSE2018-08-240000-00-00NoNoCurrent