NDC product
HYPERHEP B
NDC 13533-636 · GRIFOLS USA, LLC
Key facts
| Product NDC | 13533-636 |
|---|---|
| Proprietary name | HYPERHEP B |
| Nonproprietary name | HEPATITIS B IMMUNE GLOBULIN (HUMAN) |
| Substances | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
| Dosage form | INJECTION |
| Route | INTRAMUSCULAR |
| Labeler | GRIFOLS USA, LLC |
| Product type | PLASMA DERIVATIVE |
| Marketing category | BLA |
| Application number | BLA101146 |
| Pharmacologic classes | Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT] |
| Marketing start | Oct 9, 1996 |
| Listing certified through | Dec 31, 2026 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: