IQIRVO
- Product NDC
- 15054-0080
- 11-digit product format
- 150540080
- Labeler code
- 15054
- Product ID
- 15054-0080_614b2fb1-3b17-49e1-a63d-869acaafa72e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- elafibranor
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ipsen Biopharmaceuticals, Inc.
- Application
- NDA218860
- Marketing category
- NDA
- Marketing start
- 2024-06-10
- Substance
- ELAFIBRANOR
- Active strength
- 80 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
- IQIRVO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELAFIBRANOR | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2J3H5C81A5 |
| Rxcui | 2684946, 2684952 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15054-0080-1 | IQIRVO | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 15054-0080-1 | IQIRVO | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15054-0080 | IQIRVO (ELAFIBRANOR) TABLET, FILM COATED [IPSEN BIOPHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20240613_d78aa14f-6ec1-4b1d-a4ae-e48658137a25.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 15054-0080-1 | 15054008001 | 1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-06-10 | No | No | Current |