Home NDC 83513-009 BEIZRAY
Product NDC 83513-009
11-digit product format 835130009
Labeler code 83513
Product ID 83513-009_5e3e40bd-b191-a102-e063-6294a90a0c27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Zhuhai Beihai Biotech Co., Ltd.
Application NDA218711
Marketing category NDA
Marketing start 2024-10-23
Substance DOCETAXEL ANHYDROUS
Active strength 20 mg/mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 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 N218711-002 BEIZRAY DOCETAXEL 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-12-10
Orange Book patents# Current patent rows page 1 of 1 · 22 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 N218711-002 11419842 2036-05-16 U-4027 Drug product 2026-09-10 N218711-002 11419842 2036-05-16 U-4028 Drug product 2026-09-10 N218711-002 11419842 2036-05-16 U-881 Drug product 2026-09-10 N218711-002 11419842 2036-05-16 U-937 Drug product 2026-09-10 N218711-002 11419842 2036-05-16 U-946 Drug product 2026-09-10 N218711-002 12090134 2036-05-16 U-4027 Drug product 2026-09-10 N218711-002 12090134 2036-05-16 U-4028 Drug product 2026-09-10 N218711-002 12090134 2036-05-16 U-881 Drug product 2026-09-10 N218711-002 12090134 2036-05-16 U-937 Drug product 2026-09-10 N218711-002 12090134 2036-05-16 U-946 Drug product 2026-09-10 N218711-002 12090135 2036-05-16 Drug product 2026-09-10
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N218711-001 BEIZRAY 80MG/4ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-10-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 BEIZRAY 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-12-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218711-001 BEIZRAY 80MG/4ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-002 BEIZRAY 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218711-001 BEIZRAY 80MG/4ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218711-002 BEIZRAY 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-12-10 caaa826d4ba7…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 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N218711-001 11419842 2036-05-16 U-881 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 11419842 2036-05-16 U-937 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 11419842 2036-05-16 U-946 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 11419842 2036-05-16 U-4027 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 11419842 2036-05-16 U-4028 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 12090134 2036-05-16 U-881 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 12090134 2036-05-16 U-937 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 12090134 2036-05-16 U-946 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 12090134 2036-05-16 U-4027 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 12090134 2036-05-16 U-4028 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-001 12090135 2036-05-16 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 11419842 2036-05-16 U-946 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 11419842 2036-05-16 U-881 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 11419842 2036-05-16 U-937 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 11419842 2036-05-16 U-4027 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 11419842 2036-05-16 U-4028 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 12090134 2036-05-16 U-946 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 12090134 2036-05-16 U-881 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 12090134 2036-05-16 U-937 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 12090134 2036-05-16 U-4027 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 12090134 2036-05-16 U-4028 Drug product 2026-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218711-002 12090135 2036-05-16 Drug product 2026-09-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218711-001 11419842 2036-05-16 U-881 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 11419842 2036-05-16 U-937 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 11419842 2036-05-16 U-946 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 11419842 2036-05-16 U-4027 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 11419842 2036-05-16 U-4028 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 12090134 2036-05-16 U-881 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 12090134 2036-05-16 U-937 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 12090134 2036-05-16 U-946 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 12090134 2036-05-16 U-4027 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 12090134 2036-05-16 U-4028 Drug product 2024-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218711-001 12090135 2036-05-16 Drug product 2024-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218711-001 11419842 2036-05-16 U-881 Drug product 2024-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218711-001 11419842 2036-05-16 U-937 Drug product 2024-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218711-001 11419842 2036-05-16 U-946 Drug product 2024-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218711-001 11419842 2036-05-16 U-4027 Drug product 2024-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218711-001 11419842 2036-05-16 U-4028 Drug product 2024-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218711-001 12090134 2036-05-16 U-881 Drug product 2024-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218711-001 12090134 2036-05-16 U-937 Drug product 2024-11-13 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base BEIZRAY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCETAXEL ANHYDROUS 20 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83513-009-01 BEIZRAY 4 mL in 1 VIAL, GLASS INJECTION, SOLUTION 4 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83513-009 BEIZRAY (DOCETAXEL) KIT [ZHUHAI BEIHAI BIOTECH CO., LTD.] 7 Current NDC, 1 package rows 20241106_3538b979-8cac-49ed-b8dc-50f73ce38c72.zip
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 · 1 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83513-009-01 83513000901 4 mL in 1 VIAL, GLASS (83513-009-01) 4 ml 2024-10-23 No No Current