GOHIBIC
- Product NDC
- 83000-110
- 11-digit product format
- 830000110
- Labeler code
- 83000
- Product ID
- 83000-110_2c67a1db-151c-d067-e063-6394a90a5b06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vilobelimab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- InflaRx GmbH
- Marketing category
- EMERGENCY USE AUTHORIZATION
- Marketing start
- 2023-04-04
- Substance
- VILOBELIMAB
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GOHIBIC
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VILOBELIMAB | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5T0RF9ZJA |
| Rxcui | 2639630, 2639636 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83000-110-04 | GOHIBIC | 4 in 1 CARTON | INJECTION | 4 | | 7 |
| 83000-110-04 | GOHIBIC | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 20 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83000-110 | GOHIBIC (VILOBELIMAB) INJECTION [INFLARX GMBH] | 7 | Current NDC, 2 package rows | 20250125_6a571038-1f6c-4e66-937c-ddf6e2a4e30a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83000-110-04 | 83000011004 | 4 VIAL, SINGLE-DOSE in 1 CARTON (83000-110-04) / 20 mL in 1 VIAL, SINGLE-DOSE | 2023-04-04 | No | No | Current |