Enjaymo
- Product NDC
- 80203-347
- 11-digit product format
- 802030347
- Labeler code
- 80203
- Product ID
- 80203-347_6b1f36e8-41c9-4d12-b265-49c9d819c58b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sutimlimab-jome
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Bioverativ U.S. LLC.
- Application
- BLA761164
- Marketing category
- BLA
- Marketing start
- 2022-02-04
- Marketing end
- 0000-00-00
- Substance
- SUTIMLIMAB
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80203-347-01 | Enjaymo | 22 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 22 | | 10 |
| 80203-347-01 | Enjaymo | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80203-347 | ENJAYMO (SUTIMLIMAB-JOME) INJECTION, SOLUTION, CONCENTRATE [BIOVERATIV THERAPEUTICS INC.] | 10 | Legacy NDC, 2 package rows | 20240511_281cf1d4-6296-4416-858e-9bff46d01b71.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 |
|---|
| 80203-347-01 | 80203034701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (80203-347-01) > 22 mL in 1 VIAL, SINGLE-DOSE | 2022-02-04 | 0000-00-00 | No | No | Current |