HepaGam B
- Product NDC
- 70257-053
- 11-digit product format
- 702570053
- Labeler code
- 70257
- Product ID
- 70257-053_56525de0-f47d-11eb-85b4-0800200c9a66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- human hepatitis B virus immune globulin
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Saol Therapeutics Inc.
- Application
- BLA125035
- Marketing category
- BLA
- Marketing start
- 2018-06-20
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70257-053-51 | 70257005351 | 1 VIAL, GLASS in 1 CARTON (70257-053-51) > 1 mL in 1 VIAL, GLASS (70257-053-11) | 2018-06-20 | 0000-00-00 | No | No | Current |