NDC 68516-5214
ALBUTEIN
Albumin (human)
ALBUTEIN is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Albumin Human.
| Product ID | 68516-5214_0784e631-4dc4-4201-966f-c501fc37d334 |
| NDC | 68516-5214 |
| Product Type | Plasma Derivative |
| Proprietary Name | ALBUTEIN |
| Generic Name | Albumin (human) |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 1978-08-15 |
| Marketing Category | BLA / BLA |
| Application Number | BLA102478 |
| Labeler Name | GRIFOLS USA, LLC |
| Substance Name | ALBUMIN HUMAN |
| Active Ingredient Strength | 13 g/250mL |
| Pharm Classes | Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 68516-5214-1
1 VIAL in 1 CARTON (68516-5214-1) > 250 mL in 1 VIAL (68516-5214-3)
| Marketing Start Date | 1978-08-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 68516-5214-3 [68516521403]
ALBUTEIN INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102478 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2013-02-13 |
NDC 68516-5214-1 [68516521401]
ALBUTEIN INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102478 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1978-08-15 |
NDC 68516-5214-5 [68516521405]
ALBUTEIN INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102478 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-07-08 |
NDC 68516-5214-2 [68516521402]
ALBUTEIN INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102478 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 1978-08-15 |
NDC 68516-5214-6 [68516521406]
ALBUTEIN INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102478 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2016-07-08 |
NDC 68516-5214-4 [68516521404]
ALBUTEIN INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA102478 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2013-02-13 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ALBUMIN HUMAN | 12.5 g/250mL |
Pharmacological Class
- Human Serum Albumin [EPC]
- Increased Intravascular Volume [PE]
- Increased Oncotic Pressure [PE]
- Osmotic Activity [MoA]
- Serum Albumin [Chemical/Ingredient]
NDC Crossover Matching brand name "ALBUTEIN" or generic name "Albumin (human)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68516-5214 | ALBUTEIN | ALBUMIN (HUMAN) |
| 68516-5215 | ALBUTEIN | ALBUMIN (HUMAN) |
| 68516-5216 | ALBUTEIN | ALBUMIN (HUMAN) |
| 0053-7680 | Albuminar-25 | Albumin (Human) |
| 0053-7670 | Albuminar-5 | Albumin (Human) |
| 44206-251 | AlbuRx | ALBUMIN (HUMAN) |
| 44206-310 | ALBURX | ALBUMIN (HUMAN) |
| 61953-0001 | HUMAN ALBUMIN GRIFOLS | ALBUMIN (HUMAN) |
| 61953-0002 | HUMAN ALBUMIN GRIFOLS | ALBUMIN (HUMAN) |
| 13533-683 | Plasbumin | Albumin (Human) |
| 13533-684 | Plasbumin | Albumin (Human) |
| 13533-690 | Plasbumin | Albumin (Human) |
| 13533-691 | Plasbumin | Albumin (Human) |
| 13533-692 | Plasbumin | Albumin (Human) |
Trademark Results [ALBUTEIN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALBUTEIN 72417224 0964012 Live/Registered |
ABBOTT LABORATORIES 1972-03-03 |
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