HepaGam B
- Product NDC
- 70504-0052
- 11-digit product format
- 705040052
- Labeler code
- 70504
- Product ID
- 70504-0052_b48585cc-3cbb-4a27-8364-963a20623aaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hepatitis B Immune Globulin (Human)
- Dosage form
- INJECTION, 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70504-0052-2 | 70504005202 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70504-0052-2) > 1 mL in 1 VIAL, SINGLE-DOSE (70504-0052-1) | 2016-07-01 | 0000-00-00 | No | No | Current |