FDA.reportPublic FDA data

Docetaxel

Product NDC
62332-678
11-digit product format
623320678
Labeler code
62332
Product ID
62332-678_59e116c8-6ba0-4459-b71b-75ad9492ff14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215744
Marketing category
ANDA
Marketing start
2023-02-28
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii699121PHCA
Rxcui1093280, 1860619

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
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
62332-678-02Docetaxel2 mL in 1 VIAL, SINGLE-DOSEINJECTION211
62332-678-02Docetaxel1 in 1 CARTONINJECTION111
62332-678-08Docetaxel1 in 1 CARTONINJECTION111
62332-678-08Docetaxel8 mL in 1 VIAL, MULTI-DOSEINJECTION811
62332-678-16Docetaxel16 mL in 1 VIAL, MULTI-DOSEINJECTION1611
62332-678-16Docetaxel1 in 1 CARTONINJECTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-678-02ML - Milliliter62332-678ffeabde1-6ac1-434b-8c1d-2349d9a7c68812023-06-06
62332-678-08ML - Milliliter62332-678f0ef69f4-4cf7-4bfb-a77b-dde35bc16d4e12023-06-06
62332-678-16ML - Milliliter62332-67843433b69-f8fa-45cc-9a5a-e47050a3ef9b12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-678DOCETAXEL INJECTION [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, 6 package rows20230905_3a49c281-8cfd-4698-a9df-90ba800058ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093280DOCEtaxel 10 MG/ML Injectable SolutionPSN3a49c281-8cfd-4698-a9df-90ba800058ef11
1860619DOCEtaxel 20 MG in 2 ML InjectionPSN3a49c281-8cfd-4698-a9df-90ba800058ef11
18606192 ML docetaxel 10 MG/ML InjectionSCD3a49c281-8cfd-4698-a9df-90ba800058ef11
1093280docetaxel 10 MG/ML Injectable SolutionSCD3a49c281-8cfd-4698-a9df-90ba800058ef11
1860619docetaxel 20 MG per 2 ML InjectionSY3a49c281-8cfd-4698-a9df-90ba800058ef11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-678-02623320678021 VIAL, SINGLE-DOSE in 1 CARTON (62332-678-02) / 2 mL in 1 VIAL, SINGLE-DOSE2023-02-28NoNoCurrent
62332-678-08623320678081 VIAL, MULTI-DOSE in 1 CARTON (62332-678-08) / 8 mL in 1 VIAL, MULTI-DOSE2023-02-28NoNoCurrent
62332-678-16623320678161 VIAL, MULTI-DOSE in 1 CARTON (62332-678-16) / 16 mL in 1 VIAL, MULTI-DOSE2023-02-28NoNoCurrent