BEIZRAY

Product NDC: 70710-2091
11-digit product format: 707102091
Labeler code: 70710
Product ID: 70710-2091_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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218711-001	BEIZRAY	DOCETAXEL	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2024-10-23

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13
N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13
N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13
N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13
N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-4027	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-4028	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-946	Drug product	2024-11-13
N218711-001	12090135	2036-05-16		Drug product	2024-11-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD	2024-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	12090134	2036-05-16	U-946	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	12090134	2036-05-16	U-4027	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	12090134	2036-05-16	U-4028	Drug product	2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218711-001	12090135	2036-05-16		Drug product	2024-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	12090134	2036-05-16	U-946	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	12090134	2036-05-16	U-4027	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	12090134	2036-05-16	U-4028	Drug product	2024-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	12090135	2036-05-16		Drug product	2024-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	12090134	2036-05-16	U-946	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	12090134	2036-05-16	U-4027	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	12090134	2036-05-16	U-4028	Drug product	2024-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218711-001	12090135	2036-05-16		Drug product	2024-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13	`fd3edfee7708…`

Additional Listing Data#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
699121PHCA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1860480	Internal RxNorm lookup
1860485	Internal RxNorm lookup
2054168	Internal RxNorm lookup
2054170	Internal RxNorm lookup
2697044	Internal RxNorm lookup
2723663	Internal RxNorm lookup
2723664	Internal RxNorm lookup
2723665	Internal RxNorm lookup
2723666	Internal RxNorm lookup
2728902	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8fb7d980-d6c7-468b-a9f0-adff16101a4b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
be52172d-e80b-4aac-aa81-254100bce67f	Product name	9	20260304
c4fcacbc-a699-410c-905b-642c4d134e72	Product name	1	20250616
ad3381c5-7539-4a18-83b7-e7382b118d04	Product name	1	20231117
60a22813-7270-4733-af61-30636bce9f0f	Product name	4	20180820
0179c4ba-fb03-4931-875d-b4f1ba528029	Product name	1	20160107
9ff92ef8-2da9-4645-bbf8-642e7eb0d754	Product name	1	20150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64208-2512-4	BEIZRAY	50 mL in 1 VIAL, GLASS	SOLUTION	50 mL	0.25 g in 1mL	4
70710-2090-1	BEIZRAY	4 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	4 mL	20 mg in 1mL	4
70710-2091-3	BEIZRAY	1 in 1 KIT	KIT	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-2091-3	ML - Milliliter	70710-2091	f85cca37-31c6-4f54-a4ce-5bd97f128adf	1	2025-11-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BEIZRAY	DOCETAXEL	Zydus Pharmaceuticals USA Inc.	8fb7d980-d6c7-468b-a9f0-adff16101a4b	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218711 application number: NDA218711 ndc (product): 70710-2091
BEIZRAY	DOCETAXEL	Zhuhai Beihai Biotech Co., Ltd.	3538b979-8cac-49ed-b8dc-50f73ce38c72	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218711 application number: NDA218711

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15H5577CQD	DOCETAXEL	148408-66-6	docetaxel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL 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]	BPCK	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
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]	BPCK	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723663	{1 (4 ML docetaxel 20 MG/ML Injection) / 1 (50 ML albumin human-kjda 250 MG/ML Injection) } Pack	GPCK	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723665	{2 (4 ML docetaxel 20 MG/ML Injection) / 1 (50 ML albumin human-kjda 250 MG/ML Injection) } Pack	GPCK	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054168	albumin human-kjda 25 % in 50 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054170	ALBUMINEX 25 % in 50 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723666	BEIZRAY 160 MG Kit	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2728902	BEIZRAY 20 MG in 1 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2697044	BEIZRAY 80 MG in 4 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723664	BEIZRAY 80 MG Kit	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723665	DOCEtaxel 160 MG Kit	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860480	DOCEtaxel 20 MG in 1 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860485	DOCEtaxel 80 MG in 4 ML Injection	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723663	DOCEtaxel 80 MG Kit	PSN	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2728902	1 ML docetaxel 20 MG/ML Injection [Beizray]	SBD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2697044	4 ML docetaxel 20 MG/ML Injection [Beizray]	SBD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054170	50 ML albumin human-kjda 250 MG/ML Injection [Albuminex]	SBD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860480	1 ML docetaxel 20 MG/ML Injection	SCD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860485	4 ML docetaxel 20 MG/ML Injection	SCD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054168	50 ML albumin human-kjda 250 MG/ML Injection	SCD	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054168	albumin human-kjda 25 % per 50 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054168	albumin human-kjda 250 MG/ML per 50 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054170	Albuminex 25 % per 50 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2054170	Albuminex 250 MG/ML per 50 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723666	Beizray 160 MG Kit	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2728902	Beizray 20 MG per 1 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723664	Beizray 80 MG Kit	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2697044	Beizray 80 MG per 4 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723665	docetaxel 160 MG Kit	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860480	docetaxel 20 MG per 1 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
2723663	docetaxel 80 MG Kit	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4
1860485	docetaxel 80 MG per 4 ML Injection	SY	8fb7d980-d6c7-468b-a9f0-adff16101a4b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64208-2512-4	64208251204	50 mL in 1 VIAL, GLASS	50 ml				Historical
70710-2090-1	70710209001	4 mL in 1 VIAL, GLASS	4 ml				Historical
70710-2091-3	70710209103	1 KIT in 1 KIT (70710-2091-3) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4)	1 kit	2025-08-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BEIZRAY	Zydus Pharmaceuticals USA Inc. \| Kindos Pharmaceuticals Co., Ltd. \| Ningbo Shuangcheng Pharmaceutical Co., Ltd \| Bio Products Laboratory Ltd.	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	4