Data / Drug companies / Grifols USA, LLC
Grifols USA, LLC: 19 products in the FDA NDC directory, labeler code 13533
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Grifols USA, LLC (labeler code 13533) lists 19 products in the FDA National Drug Code Directory, covering 12 finished drugs by generic name. By type: 19 plasma derivatives. Its main marketing category is biologics (BLA). The newest product started marketing on December 16, 2025.
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- Labeler code
- 13533
- Products in commercial distribution
- 19
- Packages
- 44
- Finished drugs by generic name
- 12
- Prescription products
- 0
- Over the counter products
- 0
- Started marketing in the last 12 months
- 1
- Earliest marketing start
- October 2, 1958
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Biologics (BLA) | 19 | 100% |
Products by type
| Type | Products | Share |
|---|---|---|
| Plasma derivatives | 19 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Immune globulin (human) | 3 | 3 |
| Albumin (human) | 3 | 6 |
| Antithrombin iii (human) | 2 | 1 |
| Alpha-1-proteinase inhibitor (human) | 2 | 2 |
| Rho(d) immune globulin (human) | 2 | 1 |
| Rabies immune globulin (human) | 1 | 1 |
| Alpha1-proteinase inhibitor (human) | 1 | 1 |
| Immune globulin subcutaneous, human-klhw | 1 | 1 |
| Fibrinogen, human-chmt | 1 | 1 |
| Hepatitis b immune globulin (human) | 1 | 2 |
| Plasma protein fraction (human) | 1 | 1 |
| Tetanus immune globulin (human) | 1 | 1 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Solution | 7 | 36.8% |
| Kit | 5 | 26.3% |
| Injection | 4 | 21.1% |
| Injection, solution | 3 | 15.8% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Human Immunoglobulin G | 6 |
| Human Serum Albumin | 4 |
| Human alpha-1 Proteinase Inhibitor | 1 |
| Human Immunoglobulin | 1 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Fesilty | 13533-502 | Kit | Biologics (BLA) | December 16, 2025 |
| Xembify | 13533-810 | Solution | Biologics (BLA) | July 3, 2019 |
| GamaSTAN | 13533-335 | Injection, solution | Biologics (BLA) | February 5, 2018 |
| Gamunex-C | 13533-805 | Injection | Biologics (BLA) | October 13, 2010 |
| Gamunex-C | 13533-800 | Injection | Biologics (BLA) | October 13, 2010 |
| Hyperhep b | 13533-636 | Injection | Biologics (BLA) | October 9, 1996 |
| Hyperrho mini-dose | 13533-661 | Solution | Biologics (BLA) | August 14, 1996 |
| HyperTET | 13533-634 | Injection | Biologics (BLA) | August 14, 1996 |
| Hyperrho full dose | 13533-631 | Solution | Biologics (BLA) | August 14, 1996 |
| Plasbumin | 13533-692 | Solution | Biologics (BLA) | September 26, 1994 |
| Plasbumin | 13533-691 | Solution | Biologics (BLA) | September 26, 1994 |
| Plasbumin | 13533-690 | Solution | Biologics (BLA) | September 26, 1994 |
| Thrombate iii | 13533-606 | Kit | Biologics (BLA) | December 30, 1991 |
| Thrombate iii | 13533-602 | Kit | Biologics (BLA) | December 30, 1991 |
| Prolastin-c | 13533-706 | Kit | Biologics (BLA) | December 2, 1987 |
| Prolastin-C Liquid | 13533-705 | Injection, solution | Biologics (BLA) | December 2, 1987 |
| Prolastin-c | 13533-703 | Kit | Biologics (BLA) | December 2, 1987 |
| HyperRAB | 13533-318 | Injection, solution | Biologics (BLA) | June 12, 1974 |
| Plasmanate | 13533-613 | Solution | Biologics (BLA) | October 2, 1958 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.