Revcovi
- Product NDC
- 10122-502
- 11-digit product format
- 101220502
- Labeler code
- 10122
- Product ID
- 10122-502_964401e1-52e5-4c34-b5b5-d028ce092dd9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- elapegademase-lvlr
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Chiesi USA, Inc.
- Application
- BLA761092
- Marketing category
- BLA
- Marketing start
- 2018-10-05
- Substance
- ELAPEGADEMASE
- Active strength
- 1.6 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Revcovi
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELAPEGADEMASE | 1.6 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9R3D3Y0UHS |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10122-502-01 | Revcovi | 1.5 mL in 1 VIAL | INJECTION | 1.5 | | 5 |
| 10122-502-01 | Revcovi | 1 in 1 CARTON | INJECTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10122-502 | REVCOVI (ELAPEGADEMASE-LVLR) INJECTION [CHIESI USA, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220902_8c073f84-cdd0-40e4-b3a9-172687267f28.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 |
|---|
| 10122-502-01 | 10122050201 | 1 VIAL in 1 CARTON (10122-502-01) / 1.5 mL in 1 VIAL | 1 vial | 2018-10-05 | 0000-00-00 | No | No | Current |