Lamzede
- Product NDC
- 10122-180
- 11-digit product format
- 101220180
- Labeler code
- 10122
- Product ID
- 10122-180_27cf090b-196e-4330-8184-c72d9bb90660
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Velmanase alfa-tycv
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Chiesi USA, Inc.
- Application
- BLA761278
- Marketing category
- BLA
- Marketing start
- 2023-03-01
- Substance
- VELMANASE ALFA-TYCV
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamzede
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VELMANASE ALFA-TYCV | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M91TG242P2 |
| Rxcui | 2630729, 2630734 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10122-180-02 | Lamzede | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 10122-180-05 | Lamzede | 5 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 5 | | 1 |
| 10122-180-10 | Lamzede | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10122-180 | LAMZEDE (VELMANASE ALFA-TYCV) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIESI USA, INC.] | 1 | Current NDC, 3 package rows | 20230301_36d50a08-60bd-40eb-807c-778d69bf2d2e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10122-180-02 | 10122018002 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-02) | 2023-03-01 | No | No | Current |
| 10122-180-05 | 10122018005 | 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-05) | 2023-03-01 | No | No | Current |
| 10122-180-10 | 10122018010 | 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (10122-180-10) | 2023-03-01 | No | No | Current |