MEPSEVII
- Product NDC
- 69794-001
- 11-digit product format
- 697940001
- Labeler code
- 69794
- Product ID
- 69794-001_6e20f052-5a5f-41cd-ab55-97b8a9bf6562
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vestronidase alfa
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Ultragenyx Pharmaceutical Inc.
- Application
- BLA761047
- Marketing category
- BLA
- Marketing start
- 2017-11-15
- Substance
- VESTRONIDASE ALFA
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Lysosomal beta Glucuronidase [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MEPSEVII
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VESTRONIDASE ALFA | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7XZ4062R17 |
| Rxcui | 1989823, 1989828 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69794-001-01 | MEPSEVII | 5 mL in 1 VIAL, SINGLE-USE | INJECTION | 5 | | 17 |
| 69794-001-01 | MEPSEVII | 1 in 1 CARTON | INJECTION | 1 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69794-001 | MEPSEVII (VESTRONIDASE ALFA) INJECTION [ULTRAGENYX PHARMACEUTICAL INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250117_925d4e21-fd98-474d-a34d-a0b3558ed750.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69794-001-01 | 69794000101 | 1 VIAL, SINGLE-USE in 1 CARTON (69794-001-01) / 5 mL in 1 VIAL, SINGLE-USE | 2017-11-15 | 0000-00-00 | No | No | Current |