BEIZRAY

Product NDC
83513-009
11-digit product format
835130009
Labeler code
83513
Product ID
83513-009_45f7d427-0830-1612-e063-6294a90a04d2
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
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218711-001BEIZRAYDOCETAXEL80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-23

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218711-001114198422036-05-16U-4027Drug product2024-11-13
N218711-001114198422036-05-16U-4028Drug product2024-11-13
N218711-001114198422036-05-16U-881Drug product2024-11-13
N218711-001114198422036-05-16U-937Drug product2024-11-13
N218711-001114198422036-05-16U-946Drug product2024-11-13
N218711-001120901342036-05-16U-4027Drug product2024-11-13
N218711-001120901342036-05-16U-4028Drug product2024-11-13
N218711-001120901342036-05-16U-881Drug product2024-11-13
N218711-001120901342036-05-16U-937Drug product2024-11-13
N218711-001120901342036-05-16U-946Drug product2024-11-13
N218711-001120901352036-05-16Drug product2024-11-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD2024-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-232680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-23d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218711-001BEIZRAY80MG/4ML (20MG/ML)SOLUTION / INTRAVENOUSRLD, RS2024-10-23a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218711-001114198422036-05-16U-881Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001114198422036-05-16U-937Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001114198422036-05-16U-946Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001114198422036-05-16U-4027Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001114198422036-05-16U-4028Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001120901342036-05-16U-881Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001120901342036-05-16U-937Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001120901342036-05-16U-946Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001120901342036-05-16U-4027Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001120901342036-05-16U-4028Drug product2024-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218711-001120901352036-05-16Drug product2024-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001114198422036-05-16U-881Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001114198422036-05-16U-937Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001114198422036-05-16U-946Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001114198422036-05-16U-4027Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001114198422036-05-16U-4028Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001120901342036-05-16U-881Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001120901342036-05-16U-937Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001120901342036-05-16U-946Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001120901342036-05-16U-4027Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001120901342036-05-16U-4028Drug product2024-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218711-001120901352036-05-16Drug product2024-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N218711-001114198422036-05-16U-881Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001114198422036-05-16U-937Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001114198422036-05-16U-946Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001114198422036-05-16U-4027Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001114198422036-05-16U-4028Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001120901342036-05-16U-881Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001120901342036-05-16U-937Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001120901342036-05-16U-946Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001120901342036-05-16U-4027Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001120901342036-05-16U-4028Drug product2024-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218711-001120901352036-05-16Drug product2024-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218711-001114198422036-05-16U-881Drug product2024-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218711-001114198422036-05-16U-937Drug product2024-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218711-001114198422036-05-16U-946Drug product2024-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218711-001114198422036-05-16U-4027Drug product2024-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218711-001114198422036-05-16U-4028Drug product2024-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218711-001120901342036-05-16U-881Drug product2024-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218711-001120901342036-05-16U-937Drug product2024-11-13fd3edfee7708…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL ANHYDROUS20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
699121PHCAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1860480Internal RxNorm lookup
1860485Internal RxNorm lookup
2697044Internal RxNorm lookup
2728902Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3538b979-8cac-49ed-b8dc-50f73ce38c72Available on FDA.report

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
83513-009-01BEIZRAY4 mL in 1 VIAL, GLASSINJECTION, SOLUTION412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83513-009BEIZRAY (DOCETAXEL) KIT [ZHUHAI BEIHAI BIOTECH CO., LTD.]7Current NDC, 1 package rows20241106_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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BEIZRAYDOCETAXELZydus Pharmaceuticals USA Inc.8fb7d980-d6c7-468b-a9f0-adff16101a4b2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 218711
application number: NDA218711
BEIZRAYDOCETAXELZhuhai Beihai Biotech Co., Ltd.3538b979-8cac-49ed-b8dc-50f73ce38c722025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 218711
application number: NDA218711
ndc (product): 83513-009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2728902BEIZRAY 20 MG in 1 ML InjectionPSN3538b979-8cac-49ed-b8dc-50f73ce38c7212
2697044BEIZRAY 80 MG in 4 ML InjectionPSN3538b979-8cac-49ed-b8dc-50f73ce38c7212
1860480DOCEtaxel 20 MG in 1 ML InjectionPSN3538b979-8cac-49ed-b8dc-50f73ce38c7212
1860485DOCEtaxel 80 MG in 4 ML InjectionPSN3538b979-8cac-49ed-b8dc-50f73ce38c7212
27289021 ML docetaxel 20 MG/ML Injection [Beizray]SBD3538b979-8cac-49ed-b8dc-50f73ce38c7212
26970444 ML docetaxel 20 MG/ML Injection [Beizray]SBD3538b979-8cac-49ed-b8dc-50f73ce38c7212
18604801 ML docetaxel 20 MG/ML InjectionSCD3538b979-8cac-49ed-b8dc-50f73ce38c7212
18604854 ML docetaxel 20 MG/ML InjectionSCD3538b979-8cac-49ed-b8dc-50f73ce38c7212
2728902Beizray 20 MG per 1 ML InjectionSY3538b979-8cac-49ed-b8dc-50f73ce38c7212
2697044Beizray 80 MG per 4 ML InjectionSY3538b979-8cac-49ed-b8dc-50f73ce38c7212
1860480docetaxel 20 MG per 1 ML InjectionSY3538b979-8cac-49ed-b8dc-50f73ce38c7212
1860485docetaxel 80 MG per 4 ML InjectionSY3538b979-8cac-49ed-b8dc-50f73ce38c7212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83513-009-01835130009014 mL in 1 VIAL, GLASS (83513-009-01) 4 ml2024-10-23NoNoCurrent