HepaGam B
- Product NDC
- 70257-051
- 11-digit product format
- 702570051
- Labeler code
- 70257
- Product ID
- 70257-051_239012ee-5f14-4aed-9b1d-4e3e3283406f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hepatitis B Immune Globulin Intravenous (Human)
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Saol Therapeutics Inc.
- Application
- BLA125035
- Marketing category
- BLA
- Marketing start
- 2019-03-01
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70257-051 | HEPAGAM B (HEPATITIS B IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) INJECTION [SAOL THERAPEUTICS INC.] | 2 | Legacy NDC | 20210330_2ba8df27-4f35-41f6-8148-0c213c18df4e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70257-051-51 | 70257005151 | 1 VIAL, GLASS in 1 CARTON (70257-051-51) > 5 mL in 1 VIAL, GLASS (70257-051-05) | 2019-03-01 | 0000-00-00 | No | No | Current |