HepaGam B
- Product NDC
- 49591-051
- 11-digit product format
- 495910051
- Labeler code
- 49591
- Product ID
- 49591-051_4c139c86-d0dc-1a10-e063-6294a90a8e1d
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Kamada Ltd.
- Application
- BLA125035
- Marketing category
- BLA
- Marketing start
- 2025-10-01
- Substance
- HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
- Active strength
- 312 [iU]/mL
- Pharmacologic classes
- Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HepaGam B
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN | 312 [iU]/mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49591-051-05 | HepaGam B | 5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 5 | | 4 |
| 49591-051-51 | HepaGam B | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49591-051 | HEPAGAM B (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN) INJECTION, SOLUTION [KAMADA LTD.] | 3 | Current NDC, 2 package rows | 20231201_0146011c-944b-4251-8a5f-e573a3d5f8c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 49591-051-05 | 49591005105 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | Historical |
| 49591-051-51 | 49591005151 | 1 VIAL, GLASS in 1 CARTON (49591-051-51) / 5 mL in 1 VIAL, GLASS (49591-051-05) | | 2025-10-01 | No | No | Historical |