Cytogam
- Product NDC
- 70257-532
- 11-digit product format
- 702570532
- Labeler code
- 70257
- Product ID
- 70257-532_2a40733c-106b-41cf-94f0-f10a03180ac8
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Cytomegalovirus Immune Globulin Intravenous (Human)
- Dosage form
- LIQUID
- Route
- INTRAVENOUS
- Labeler
- Saol Therapeutics Inc.
- Application
- BLA103189
- Marketing category
- BLA
- Marketing start
- 2020-10-30
- Marketing end
- 0000-00-00
- Substance
- HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 70257-532-51 | 70257053251 | 1 VIAL, GLASS in 1 CARTON (70257-532-51) > 50 mL in 1 VIAL, GLASS (70257-532-50) | 2020-10-30 | 0000-00-00 | No | No | Current |