FDA.reportPublic FDA data

BEIZRAY

Product NDC
70710-2093
11-digit product format
707102093
Labeler code
70710
Product ID
70710-2093_4efe8f3a-a176-4b69-90c8-5ba5891dccfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
docetaxel
Dosage form
KIT
Labeler
Zydus Pharmaceuticals USA Inc.
Application
NDA218711
Marketing category
NDA
Marketing start
2025-08-28
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii699121PHCA
Rxcui1860480, 1860485, 2054168, 2054170, 2697044, 2723663, 2723664, 2723665, 2723666, 2728902

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
64208-2512-4BEIZRAY50 mL in 1 VIAL, GLASSSOLUTION50 mL0.25 g in 1mL4
70710-2090-1BEIZRAY4 mL in 1 VIAL, GLASSINJECTION, SOLUTION4 mL20 mg in 1mL4
70710-2093-4BEIZRAY1 in 1 KITKIT14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723664{1 (4 ML docetaxel 20 MG/ML Injection [Beizray]) / 1 (50 ML albumin human-kjda 250 MG/ML Injection [Albuminex]) } Pack [Beizray 80 MG Kit]BPCK8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723666{2 (4 ML docetaxel 20 MG/ML Injection [Beizray]) / 1 (50 ML albumin human-kjda 250 MG/ML Injection [Albuminex]) } Pack [Beizray 160 MG Kit]BPCK8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723663{1 (4 ML docetaxel 20 MG/ML Injection) / 1 (50 ML albumin human-kjda 250 MG/ML Injection) } PackGPCK8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723665{2 (4 ML docetaxel 20 MG/ML Injection) / 1 (50 ML albumin human-kjda 250 MG/ML Injection) } PackGPCK8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2054168albumin human-kjda 25 % in 50 ML InjectionPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2054170ALBUMINEX 25 % in 50 ML InjectionPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723666BEIZRAY 160 MG KitPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2728902BEIZRAY 20 MG in 1 ML InjectionPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2697044BEIZRAY 80 MG in 4 ML InjectionPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723664BEIZRAY 80 MG KitPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723665DOCEtaxel 160 MG KitPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
1860480DOCEtaxel 20 MG in 1 ML InjectionPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
1860485DOCEtaxel 80 MG in 4 ML InjectionPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723663DOCEtaxel 80 MG KitPSN8fb7d980-d6c7-468b-a9f0-adff16101a4b4
27289021 ML docetaxel 20 MG/ML Injection [Beizray]SBD8fb7d980-d6c7-468b-a9f0-adff16101a4b4
26970444 ML docetaxel 20 MG/ML Injection [Beizray]SBD8fb7d980-d6c7-468b-a9f0-adff16101a4b4
205417050 ML albumin human-kjda 250 MG/ML Injection [Albuminex]SBD8fb7d980-d6c7-468b-a9f0-adff16101a4b4
18604801 ML docetaxel 20 MG/ML InjectionSCD8fb7d980-d6c7-468b-a9f0-adff16101a4b4
18604854 ML docetaxel 20 MG/ML InjectionSCD8fb7d980-d6c7-468b-a9f0-adff16101a4b4
205416850 ML albumin human-kjda 250 MG/ML InjectionSCD8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2054168albumin human-kjda 25 % per 50 ML InjectionSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2054168albumin human-kjda 250 MG/ML per 50 ML InjectionSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2054170Albuminex 25 % per 50 ML InjectionSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2054170Albuminex 250 MG/ML per 50 ML InjectionSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723666Beizray 160 MG KitSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2728902Beizray 20 MG per 1 ML InjectionSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723664Beizray 80 MG KitSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2697044Beizray 80 MG per 4 ML InjectionSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723665docetaxel 160 MG KitSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
1860480docetaxel 20 MG per 1 ML InjectionSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
2723663docetaxel 80 MG KitSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4
1860485docetaxel 80 MG per 4 ML InjectionSY8fb7d980-d6c7-468b-a9f0-adff16101a4b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64208-2512-46420825120450 mL in 1 VIAL, GLASS50 mlHistorical
70710-2090-1707102090014 mL in 1 VIAL, GLASS4 mlHistorical
70710-2093-4707102093041 KIT in 1 KIT (70710-2093-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4) * 4 mL in 1 VIAL, GLASS (70710-2090-1) 1 kit2025-08-28NoNoCurrent