HepaGam B
- Product NDC
- 70504-0053
- 11-digit product format
- 705040053
- Labeler code
- 70504
- Product ID
- 70504-0053_b3195063-4432-4936-9597-43eed79f87cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hepatitis B Immune Globulin (Human)
- Dosage form
- SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Aptevo BioTherapeutics LLC
- Application
- BLA125035
- Marketing category
- BLA
- Marketing start
- 2016-07-01
- Marketing end
- 0000-00-00
- Substance
- HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
- Active strength
- 312 [iU]/mL
- Pharmacologic classes
- Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70504-0053-2 | 70504005302 | 1 VIAL in 1 CARTON (70504-0053-2) > 1 mL in 1 VIAL (70504-0053-1) | 1 vial | 2018-07-02 | 0000-00-00 | No | No | Current |