VOXZOGO 0.56mg
- Product NDC
- 68135-119
- 11-digit product format
- 681350119
- Labeler code
- 68135
- Product ID
- 68135-119_6100caa6-4951-4773-b80c-6be0c04efd24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vosoritide
- Dosage form
- KIT
- Labeler
- BioMarin Pharmaceutical Inc.
- Application
- NDA214938
- Marketing category
- NDA
- Marketing start
- 2021-11-19
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VOXZOGO 0.56mg
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 2586364, 2586369, 2586371, 2586373, 2586375, 2586377 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68135-094-84 | VOXZOGO 0.56mg | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | | 0.56 mg in 0.7mL | 16 |
| 68135-094-84 | VOXZOGO 0.56mg | 0.7 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 7 mL | 0.56 mg in 0.7mL | 16 |
| 68135-119-66 | VOXZOGO 0.56mg | 1 in 1 CARTON | KIT | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68135-119 | VOXZOGO 0.4MG (VOSORITIDE) KIT VOXZOGO 0.56MG (VOSORITIDE) KIT VOXZOGO 1.2MG (VOSORITIDE) KIT [BIOMARIN PHARMACEUTICAL INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20241220_228e8560-04a4-4bb1-a81f-29531a9e4d27.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 |
|---|
| 68135-094-84 | 68135009484 | 10 in 1 CARTON | | | | | | Historical |
| 68135-119-66 | 68135011966 | 1 KIT in 1 CARTON (68135-119-66) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-094-84) / .7 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-102-43) | 1 kit | 2021-11-19 | 0000-00-00 | No | No | Current |