Praluent
- Product NDC
- 61755-020
- 11-digit product format
- 617550020
- Labeler code
- 61755
- Product ID
- 61755-020_ad540294-d141-4655-a97b-abc9ae2795a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alirocumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Regeneron Pharmaceuticals, Inc.
- Application
- BLA125559
- Marketing category
- BLA
- Marketing start
- 2020-12-01
- Substance
- ALIROCUMAB
- Active strength
- 75 mg/mL
- Pharmacologic classes
- Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Praluent
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALIROCUMAB | 75 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PP0SHH6V16 |
| Rxcui | 1659156, 1659161, 1659182, 1659183 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61755-020-01 | Praluent | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
| 61755-020-01 | Praluent | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 9 |
| 61755-020-02 | Praluent | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 9 |
| 61755-020-02 | Praluent | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 9 |
| 61755-020-04 | Praluent | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 9 |
| 61755-020-04 | Praluent | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61755-020 | PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20240405_7bcfbac2-e8ac-4569-8edc-bcde3b1fd172.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 |
|---|
| 61755-020-01 | 61755002001 | 1 SYRINGE, GLASS in 1 CARTON (61755-020-01) / 1 mL in 1 SYRINGE, GLASS | 2020-12-01 | 0000-00-00 | No | No | Current |
| 61755-020-02 | 61755002002 | 2 SYRINGE, GLASS in 1 CARTON (61755-020-02) / 1 mL in 1 SYRINGE, GLASS | 2020-12-01 | 0000-00-00 | No | No | Current |
| 61755-020-04 | 61755002004 | 1 SYRINGE, GLASS in 1 CARTON (61755-020-04) / 1 mL in 1 SYRINGE, GLASS | 2020-12-01 | 0000-00-00 | Yes | No | Current |