Revcovi
- Product NDC
- 57665-002
- 11-digit product format
- 576650002
- Labeler code
- 57665
- Product ID
- 57665-002_35174065-15ec-4714-8c24-1feb7f715d22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- elapegademase-lvlr
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Leadiant Biosciences, Inc.
- Application
- BLA761092
- Marketing category
- BLA
- Marketing start
- 2018-10-05
- Marketing end
- 2022-08-31
- Substance
- ELAPEGADEMASE
- Active strength
- 2 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57665-002-02 | Oncaspar | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 57665-002-02 | Oncaspar | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57665-002 | ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION FOR INTRAMUSCULAR AND INTRAVENOUS USE [ENZON PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20080808_D046EC54-9AC8-4C9F-87A7-69E9900D8016.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57665-002-01 | 57665000201 | 1 VIAL in 1 CARTON (57665-002-01) > 1.5 mL in 1 VIAL | 1 vial | 2018-10-05 | 2022-08-31 | No | No | Current |
| 57665-002-02 | 57665000202 | 1 in 1 CARTON | | | | | | Historical |