FDA.reportPublic FDA data

Docetaxel anhydrous

Product NDC
71288-151
11-digit product format
712880151
Labeler code
71288
Product ID
71288-151_bde50f3a-b83d-ae1d-e053-2a95a90a3d89
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
Marketing end
0000-00-00
Substance
DOCETAXEL ANHYDROUS
Active strength
10 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71288-151-952023-01-30C16284748780-1f386c649-c9dd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996
71288-151-962023-01-30C16284748780-1f386c649-c9dd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-151-95Docetaxel anhydrous8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION82
71288-151-95Docetaxel anhydrous1 in 1 CARTONINJECTION, SOLUTION12
71288-151-96Docetaxel anhydrous1 in 1 CARTONINJECTION, SOLUTION12
71288-151-96Docetaxel anhydrous16 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION162

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-151DOCETAXEL ANHYDROUS INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC]2Legacy NDC, 4 package rows20210330_9cd030b6-f98d-451e-93cb-0a998f4c6012.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093280DOCEtaxel 10 MG/ML Injectable SolutionPSN9cd030b6-f98d-451e-93cb-0a998f4c60122
1860619DOCEtaxel 20 MG in 2 ML InjectionPSN9cd030b6-f98d-451e-93cb-0a998f4c60122
18606192 ML docetaxel 10 MG/ML InjectionSCD9cd030b6-f98d-451e-93cb-0a998f4c60122
1093280docetaxel 10 MG/ML Injectable SolutionSCD9cd030b6-f98d-451e-93cb-0a998f4c60122
1860619docetaxel 20 MG per 2 ML InjectionSY9cd030b6-f98d-451e-93cb-0a998f4c60122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-151-95712880151951 VIAL, MULTI-DOSE in 1 CARTON (71288-151-95) > 8 mL in 1 VIAL, MULTI-DOSE2018-08-240000-00-00NoNoCurrent
71288-151-96712880151961 VIAL, MULTI-DOSE in 1 CARTON (71288-151-96) > 16 mL in 1 VIAL, MULTI-DOSE2018-08-240000-00-00NoNoCurrent