Brineura
- Product NDC
- 68135-811
- 11-digit product format
- 681350811
- Labeler code
- 68135
- Product ID
- 68135-811_1ebeb049-90ec-42ff-9361-b6fa38d79515
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cerliponase alfa
- Dosage form
- KIT
- Labeler
- BioMarin Pharmaceutical Inc.
- Application
- BLA761052
- Marketing category
- BLA
- Marketing start
- 2017-04-27
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Brineura
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 1922453, 1922458 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68135-500-00 | Brineura | 5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 mL | 150 mg in 5mL | 30 |
| 68135-811-02 | Brineura | 1 in 1 CARTON | KIT | 1 | | 30 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68135-811 | BRINEURA (CERLIPONASE ALFA) KIT [BIOMARIN PHARMACEUTICAL INC.] | 30 | Current NDC, Legacy NDC, 2 package rows | 20240808_485ab3c5-0359-4878-872f-2fe1e7df4047.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 |
|---|
| 68135-500-00 | 68135050000 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | | Historical |
| 68135-811-02 | 68135081102 | 1 KIT in 1 CARTON (68135-811-02) * 5 mL in 1 VIAL, GLASS (68135-500-00) * 5 mL in 1 VIAL, GLASS (68135-495-04) | 1 kit | 2017-04-27 | 0000-00-00 | No | No | Current |