Increlex
- Product NDC
- 71863-216
- 11-digit product format
- 718630216
- Labeler code
- 71863
- Product ID
- 71863-216_52199e09-74a6-6144-e063-6294a90a59e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mecasermin
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Eton Pharmaceuticals, Inc.
- Application
- BLA021839
- Marketing category
- BLA
- Marketing start
- 2025-04-16
- Substance
- MECASERMIN
- Active strength
- 40 mg/4mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Increlex
- Listing expiration
- 2027-12-31
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 |
|---|
| 71863-216-04 | Increlex | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION | 4 | | 5 |
| 71863-216-04 | Increlex | 1 in 1 CARTON | INJECTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71863-216 | INCRELEX (MECASERMIN) INJECTION [ETON PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250508_d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71863-216-04 | 71863021604 | 1 VIAL, MULTI-DOSE in 1 CARTON (71863-216-04) / 4 mL in 1 VIAL, MULTI-DOSE | 2025-04-16 | No | No | Current |