FDA.reportPublic FDA data

Docetaxel

Product NDC
57884-3043
11-digit product format
578843043
Labeler code
57884
Product ID
57884-3043_05e0099c-4a6e-4ca4-e063-6394a90ae073
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Application
ANDA207252
Marketing category
ANDA
Marketing start
2017-08-09
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL160 mg/8mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15H5577CQD
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57884-3043-12021-08-10C16284748780-1c7ccaba7-1fb9-fd44-e053-dadaa90aa01bThese 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
57884-3043-12021-07-23C16284748780-1c7ccaba7-1fb9-fd44-e053-dadaa90aa01bThese 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
57884-3043-1Docetaxel8 mL in 1 VIAL, GLASSINJECTION, SOLUTION, CONCENTRATE821
57884-3043-1Docetaxel1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57884-3043DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [JIANGSU HENGRUI PHARMACEUTICALS CO., LTD.]21Current NDC, Legacy NDC, 2 package rows20230922_e488100d-6728-4f44-9282-f63a805b8e13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1861411DOCEtaxel 160 MG in 8 ML InjectionPSNe488100d-6728-4f44-9282-f63a805b8e1321
1860480DOCEtaxel 20 MG in 1 ML InjectionPSNe488100d-6728-4f44-9282-f63a805b8e1321
1860485DOCEtaxel 80 MG in 4 ML InjectionPSNe488100d-6728-4f44-9282-f63a805b8e1321
18604801 ML docetaxel 20 MG/ML InjectionSCDe488100d-6728-4f44-9282-f63a805b8e1321
18604854 ML docetaxel 20 MG/ML InjectionSCDe488100d-6728-4f44-9282-f63a805b8e1321
18614118 ML docetaxel 20 MG/ML InjectionSCDe488100d-6728-4f44-9282-f63a805b8e1321
1861411docetaxel 160 MG per 8 ML InjectionSYe488100d-6728-4f44-9282-f63a805b8e1321
1860480docetaxel 20 MG per 1 ML InjectionSYe488100d-6728-4f44-9282-f63a805b8e1321
1860485docetaxel 80 MG per 4 ML InjectionSYe488100d-6728-4f44-9282-f63a805b8e1321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57884-3043-1578843043011 VIAL, GLASS in 1 CARTON (57884-3043-1) / 8 mL in 1 VIAL, GLASS2017-08-090000-00-00NoNoCurrent