ELFABRIO
- Product NDC
- 10122-160
- 11-digit product format
- 101220160
- Labeler code
- 10122
- Product ID
- 10122-160_ca12aa63-7344-4996-bfb4-d2289c245f4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegunigalsidase alfa
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Chiesi USA, Inc.
- Application
- BLA761161
- Marketing category
- BLA
- Marketing start
- 2023-05-23
- Substance
- PEGUNIGALSIDASE ALFA
- Active strength
- 20 mg/10mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ELFABRIO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEGUNIGALSIDASE ALFA | 20 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8M7V7Q6537 |
| Rxcui | 2637456, 2637462, 2676759, 2676760 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10122-160-01 | ELFABRIO | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 7 |
| 10122-160-02 | ELFABRIO | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 7 |
| 10122-160-05 | ELFABRIO | 5 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 5 | | 7 |
| 10122-160-10 | ELFABRIO | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10122-160 | ELFABRIO (PEGUNIGALSIDASE ALFA) INJECTION, SOLUTION, CONCENTRATE [CHIESI USA, INC.] | 7 | Current NDC, 4 package rows | 20240709_6fb674bf-744e-431f-92ef-b2a5a66c8cf3.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 |
|---|
| 10122-160-01 | 10122016001 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 10122-160-02 | 10122016002 | 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) | | 2023-05-23 | No | No | Current |
| 10122-160-05 | 10122016005 | 5 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) | | 2023-05-23 | No | No | Current |
| 10122-160-10 | 10122016010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01) | | 2023-05-23 | No | No | Current |