Data / Drug companies / Grifols USA, LLC
Grifols USA, LLC: 21 products in the FDA NDC directory, labeler code 68516
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Grifols USA, LLC (labeler code 68516) lists 21 products in the FDA National Drug Code Directory, covering 4 finished drugs by generic name. By type: 21 plasma derivatives. Its main marketing category is biologics (BLA). The newest product started marketing on November 15, 2023.
The request: Watch Grifols USA, LLC (FDA labeler code 68516): each new product listing and each discontinued product. $10 of work on sign-up, no card.
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- Labeler code
- 68516
- Products in commercial distribution
- 21
- Packages
- 30
- Finished drugs by generic name
- 4
- Prescription products
- 0
- Over the counter products
- 0
- Started marketing in the last 12 months
- 0
- Earliest marketing start
- August 15, 1978
- 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) | 21 | 100% |
Products by type
| Type | Products | Share |
|---|---|---|
| Plasma derivatives | 21 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Albumin (human) | 7 | 6 |
| Coagulation factor ix (human) | 6 | 1 |
| Antihemophilic factor/von willebrand factor complex (human) | 5 | 2 |
| Factor ix complex | 3 | 1 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Kit | 14 | 66.7% |
| Injection, solution | 7 | 33.3% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Human Serum Albumin | 7 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Albutein | 68516-5218 | Injection, solution | Biologics (BLA) | November 15, 2023 |
| Albutein | 68516-5219 | Injection, solution | Biologics (BLA) | November 9, 2023 |
| Albutein | 68516-5216 | Injection, solution | Biologics (BLA) | March 1, 2022 |
| Albutein | 68516-5216 | Injection, solution | Biologics (BLA) | March 1, 2022 |
| Albutein | 68516-5215 | Injection, solution | Biologics (BLA) | March 1, 2022 |
| Albutein | 68516-5214 | Injection, solution | Biologics (BLA) | March 1, 2022 |
| Albutein | 68516-5215 | Injection, solution | Biologics (BLA) | November 8, 2021 |
| Alphanate | 68516-4620 | Kit | Biologics (BLA) | June 26, 2014 |
| AlphaNine SD | 68516-3612 | Kit | Biologics (BLA) | December 31, 1990 |
| AlphaNine SD | 68516-3611 | Kit | Biologics (BLA) | December 31, 1990 |
| AlphaNine SD | 68516-3610 | Kit | Biologics (BLA) | December 31, 1990 |
| AlphaNine SD | 68516-3609 | Kit | Biologics (BLA) | December 31, 1990 |
| AlphaNine SD | 68516-3608 | Kit | Biologics (BLA) | December 31, 1990 |
| AlphaNine SD | 68516-3607 | Kit | Biologics (BLA) | December 31, 1990 |
| Profilnine | 68516-3212 | Kit | Biologics (BLA) | July 20, 1981 |
| Profilnine | 68516-3211 | Kit | Biologics (BLA) | July 20, 1981 |
| Profilnine | 68516-3210 | Kit | Biologics (BLA) | July 20, 1981 |
| Alphanate | 68516-4619 | Kit | Biologics (BLA) | August 15, 1978 |
| Alphanate | 68516-4618 | Kit | Biologics (BLA) | August 15, 1978 |
| Alphanate | 68516-4617 | Kit | Biologics (BLA) | August 15, 1978 |
| Alphanate | 68516-4616 | Kit | Biologics (BLA) | August 15, 1978 |
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.