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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BEIZRAY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCETAXEL ANHYDROUS | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 699121PHCA |
| Rxcui | 1860480, 1860485, 2697044, 2728902 |
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 |
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 |