Enjaymo
- Product NDC
- 55292-820
- 11-digit product format
- 552920820
- Labeler code
- 55292
- Product ID
- 55292-820_fb86733b-25b0-48ca-97a0-8cb15eef1848
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sutimlimab-jome
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Recordati Rare Diseases, Inc.
- Application
- BLA761164
- Marketing category
- BLA
- Marketing start
- 2022-02-04
- Substance
- SUTIMLIMAB
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Classical Complement Pathway Inhibitor [EPC], Classical Complement Pathway Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Enjaymo
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SUTIMLIMAB | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GNWE7KJ995 |
| Rxcui | 2591419, 2591425 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55292-820-01 | Enjaymo | 22 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 22 | | 4 |
| 55292-820-01 | Enjaymo | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55292-820 | ENJAYMO (SUTIMLIMAB-JOME) INJECTION, SOLUTION, CONCENTRATE [RECORDATI RARE DISEASES, INC.] | 1 | Current NDC, 2 package rows | 20250110_0a25363a-7781-d9f8-cb1c-be22987bf03b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55292-820-01 | 55292082001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55292-820-01) / 22 mL in 1 VIAL, SINGLE-DOSE | 2025-06-25 | No | No | Current |