BEIZRAY
- Product NDC
- 83513-008
- 11-digit product format
- 835130008
- Labeler code
- 83513
- Product ID
- 83513-008_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
- 2025-12-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BEIZRAY
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCETAXEL ANHYDROUS | 20 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 699121PHCA |
| Rxcui | 1860480, 1860485, 2697044, 2728902 |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83513-008-01 | BEIZRAY | 1 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1 | 12 | |
| 83513-008-01 | BEIZRAY | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2728902 | BEIZRAY 20 MG in 1 ML Injection | PSN | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 2697044 | BEIZRAY 80 MG in 4 ML Injection | PSN | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 1860480 | DOCEtaxel 20 MG in 1 ML Injection | PSN | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 1860485 | DOCEtaxel 80 MG in 4 ML Injection | PSN | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 2728902 | 1 ML docetaxel 20 MG/ML Injection [Beizray] | SBD | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 2697044 | 4 ML docetaxel 20 MG/ML Injection [Beizray] | SBD | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 1860480 | 1 ML docetaxel 20 MG/ML Injection | SCD | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 1860485 | 4 ML docetaxel 20 MG/ML Injection | SCD | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 2728902 | Beizray 20 MG per 1 ML Injection | SY | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 2697044 | Beizray 80 MG per 4 ML Injection | SY | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 1860480 | docetaxel 20 MG per 1 ML Injection | SY | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
| 1860485 | docetaxel 80 MG per 4 ML Injection | SY | 3538b979-8cac-49ed-b8dc-50f73ce38c72 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83513-008-01 | 83513000801 | 1 VIAL, GLASS in 1 CARTON (83513-008-01) / 1 mL in 1 VIAL, GLASS | 2025-12-15 | No | No | Current |