NDC product

GAMASTAN

NDC 13533-635 · GRIFOLS USA, LLC

Key facts

Product NDC 13533-635
Proprietary name GAMASTAN
Nonproprietary name IMMUNE GLOBULIN (HUMAN)
Substances HUMAN IMMUNOGLOBULIN G
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler GRIFOLS USA, LLC
Product type PLASMA DERIVATIVE
Marketing category BLA
Application number BLA101134
Pharmacologic classes Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
Marketing start Aug 14, 1996
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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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:

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