ALBUTEIN
- Product NDC
- 68516-5215
- 11-digit product format
- 685165215
- Labeler code
- 68516
- Product ID
- 68516-5215_ac8771a5-ff60-46b5-b7a6-9db295c739fe
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- ALBUMIN (HUMAN)
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- GRIFOLS USA, LLC
- Application
- BLA102478
- Marketing category
- BLA
- Marketing start
- 2022-03-01
- Substance
- ALBUMIN HUMAN
- Active strength
- 10 g/50mL
- Pharmacologic classes
- Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ALBUTEIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALBUMIN HUMAN | 10 g/50mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68516-5215-1 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 15 |
| 68516-5215-2 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 15 |
| 68516-5215-3 | ALBUTEIN | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | | 15 |
| 68516-5215-4 | ALBUTEIN | 100 mL in 1 VIAL | INJECTION, SOLUTION | 100 | | 15 |
| 68516-5215-5 | ALBUTEIN | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | | 3 |
| 68516-5215-6 | ALBUTEIN | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 3 |
| 68516-5215-7 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 68516-5215-8 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Albumin (Human) | ACTIVE INGREDIENT | ZIF514RVZR | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 3 | |
| Albumin (Human) | ACTIVE MOIETY | ZIF514RVZR | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 3 | |
| Sodium Acetyltryptophanate | INACTIVE INGREDIENT | 3EN9H0M2FX | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 3 | |
| Sodium Caprylate | INACTIVE INGREDIENT | 9XTM81VK2B | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 3 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68516-5215 | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 14 | Current NDC, Legacy NDC, 4 package rows | 20230627_d18a7e13-1ef0-495c-aa57-ace2e446a823.zip |
| 68516-5215 | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 2 | Current NDC, Legacy NDC, 4 package rows | 20231201_e4304edc-8c80-4118-9d86-7a34c76aa56f.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1741295 | albumin human 20 % in 100 ML Injection | PSN | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1741290 | albumin human 20 % in 50 ML Injection | PSN | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1742220 | Albutein 20 % in 100 ML Injection | PSN | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1742217 | Albutein 20 % in 50 ML Injection | PSN | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1742220 | 100 ML albumin human, USP 200 MG/ML Injection [Albutein] | SBD | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1742217 | 50 ML albumin human, USP 200 MG/ML Injection [Albutein] | SBD | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1741295 | 100 ML albumin human, USP 200 MG/ML Injection | SCD | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1741290 | 50 ML albumin human, USP 200 MG/ML Injection | SCD | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1741290 | albumin human 10 GM per 50 ML Injection | SY | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1741295 | albumin human 20 % per 100 ML Injection | SY | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1741290 | albumin human 20 % per 50 ML Injection | SY | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1741295 | albumin human 20 GM per 100 ML Injection | SY | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1742217 | Albutein 10 GM per 50 ML Injection | SY | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1742220 | Albutein 20 % per 100 ML Injection | SY | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1742217 | Albutein 20 % per 50 ML Injection | SY | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1742220 | Albutein 20 GM per 100 ML Injection | SY | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 15 |
| 1741295 | albumin human 20 % in 100 ML Injection | PSN | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1741290 | albumin human 20 % in 50 ML Injection | PSN | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1742220 | Albutein 20 % in 100 ML Injection | PSN | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1742217 | Albutein 20 % in 50 ML Injection | PSN | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1742220 | 100 ML albumin human, USP 200 MG/ML Injection [Albutein] | SBD | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1742217 | 50 ML albumin human, USP 200 MG/ML Injection [Albutein] | SBD | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1741295 | 100 ML albumin human, USP 200 MG/ML Injection | SCD | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1741290 | 50 ML albumin human, USP 200 MG/ML Injection | SCD | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1741290 | albumin human 10 GM per 50 ML Injection | SY | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1741295 | albumin human 20 % per 100 ML Injection | SY | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1741290 | albumin human 20 % per 50 ML Injection | SY | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1741295 | albumin human 20 GM per 100 ML Injection | SY | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1742217 | Albutein 10 GM per 50 ML Injection | SY | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1742220 | Albutein 20 % per 100 ML Injection | SY | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1742217 | Albutein 20 % per 50 ML Injection | SY | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
| 1742220 | Albutein 20 GM per 100 ML Injection | SY | e4304edc-8c80-4118-9d86-7a34c76aa56f | 3 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68516-5215-1 | 68516521501 | 1 VIAL in 1 CARTON (68516-5215-1) / 50 mL in 1 VIAL (68516-5215-3) | 1 vial | 2022-03-01 | 0000-00-00 | No | No | Current |
| 68516-5215-2 | 68516521502 | 1 VIAL in 1 CARTON (68516-5215-2) / 100 mL in 1 VIAL (68516-5215-4) | 1 vial | 2022-03-01 | 0000-00-00 | No | No | Current |
| 68516-5215-3 | 68516521503 | 50 mL in 1 VIAL | 50 ml | | | | | Historical |
| 68516-5215-4 | 68516521504 | 100 mL in 1 VIAL | 100 ml | | | | | Historical |
| 68516-5215-5 | 68516521505 | 50 mL in 1 BAG | 50 ml | | | | | Historical |
| 68516-5215-6 | 68516521506 | 100 mL in 1 BAG | 100 ml | | | | | Historical |
| 68516-5215-7 | 68516521507 | 1 BAG in 1 CARTON (68516-5215-7) / 50 mL in 1 BAG (68516-5215-5) | 1 bag | 2021-11-08 | 0000-00-00 | No | No | Current |
| 68516-5215-8 | 68516521508 | 1 BAG in 1 CARTON (68516-5215-8) / 100 mL in 1 BAG (68516-5215-6) | 1 bag | 2021-11-08 | 0000-00-00 | No | No | Current |