Increlex
- Product NDC
- 15054-1040
- 11-digit product format
- 150541040
- Labeler code
- 15054
- Product ID
- 15054-1040_21eb91ba-3cd8-47f0-a27b-35e3e5fd2e10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mecasermin
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Ipsen Biopharmaceuticals, Inc.
- Application
- BLA021839
- Marketing category
- BLA
- Marketing start
- 2006-01-03
- Marketing end
- 2027-12-31
- Substance
- MECASERMIN
- Active strength
- 40 mg/4mL
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Increlex
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MECASERMIN | 40 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7GR9I2683O |
| Rxcui | 604806, 615882 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15054-1040-5 | Increlex | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 21 |
| 15054-1040-5 | Increlex | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 4 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| mecasermin | ACTIVE INGREDIENT | 7GR9I2683O | INCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] | 10 | |
| mecasermin | ACTIVE MOIETY | 7GR9I2683O | INCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] | 10 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | INCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] | 10 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | INCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] | 10 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | INCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] | 10 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | INCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15054-1040 | INCRELEX (MECASERMIN) INJECTION, SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20240322_a8b27a1b-a611-4f91-ad22-76d4b390c3ae.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 |
|---|
| 15054-1040-5 | 15054104005 | 1 VIAL, MULTI-DOSE in 1 CARTON (15054-1040-5) / 4 mL in 1 VIAL, MULTI-DOSE | 2006-01-03 | 2027-12-31 | No | No | Current |