NDC 68516-5216-3 - ALBUTEIN
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68516-5216
- Requested NDC
- 68516-5216-3
- Package NDCs from labels
- 68516-5216-3, 68516-5216-1, 68516-5216-4, 68516-5216-2, 68516-5216-6, 68516-5216-5, 68516-5216-7, 68516-5216-9, 68516-5216-8, 68516-5216-0
- Manufacturer
- GRIFOLS USA, LLC | Grifols Biologicals LLC | Grifols Therapeutics LLC | INSTITUTO GRIFOLS SA
- Effective date
- 2025-05-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| ALBUTEIN - GRIFOLS USA, LLC | Grifols Biologicals LLC | Grifols Therapeutics LLC | INSTITUTO GRIFOLS SA | GRIFOLS USA, LLC | Grifols Biologicals LLC | Grifols Therapeutics LLC | INSTITUTO GRIFOLS SA | 2025-05-28 | PLASMA DERIVATIVE |
| ALBUTEIN - GRIFOLS USA, LLC | Grifols Biologicals LLC | GRIFOLS USA, LLC | Grifols Biologicals LLC | 2025-05-28 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-5216-1 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 17 | |
| 68516-5216-2 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 17 | |
| 68516-5216-3 | ALBUTEIN | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | 17 | |
| 68516-5216-4 | ALBUTEIN | 100 mL in 1 VIAL | INJECTION, SOLUTION | 100 | 17 | |
| 68516-5216-5 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 17 | |
| 68516-5216-6 | ALBUTEIN | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | 17 | |
| 68516-5216-0 | ALBUTEIN | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 10 | |
| 68516-5216-7 | ALBUTEIN | 50 mL in 1 BAG | INJECTION, SOLUTION | 50 | 10 | |
| 68516-5216-8 | ALBUTEIN | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | 10 | |
| 68516-5216-9 | ALBUTEIN | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-5216 | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 16 | Current NDC, Legacy NDC, 6 package rows | 20231102_de634e31-d99b-4ed6-ba0a-07904d745aeb.zip |
| 68516-5216 | ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240106_a7dae31a-e41d-4bfa-9c0a-060d6e91627b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68516-5216-0 | ML - Milliliter | 68516-5216 | 0b985cf2-86c8-4c33-bb3b-14d184ed15fc | 1 | 2022-04-06 |
| 68516-5216-1 | ML - Milliliter | 68516-5216 | 736e6b0a-c975-4c1d-ac5e-7f69d227bec2 | 1 | 2012-07-24 |
| 68516-5216-2 | ML - Milliliter | 68516-5216 | 3b09760f-a0e9-4230-a1c3-3322af0cd357 | 1 | 2012-07-24 |
| 68516-5216-3 | ML - Milliliter | 68516-5216 | 48942661-8765-42f9-a2f4-36dd3eef452a | 1 | 2014-10-03 |
| 68516-5216-4 | ML - Milliliter | 68516-5216 | 8c64bd3e-8092-45bb-acb3-25506d9f1395 | 1 | 2014-10-03 |
| 68516-5216-5 | ML - Milliliter | 68516-5216 | d90271db-2597-4464-b317-f5dd0be1ee4b | 1 | 2016-07-19 |
| 68516-5216-6 | ML - Milliliter | 68516-5216 | 3150fab6-3a7a-4da3-a947-55ac05be4a04 | 1 | 2016-07-19 |
| 68516-5216-7 | ML - Milliliter | 68516-5216 | 029fc37a-c257-4bd2-a9b0-7c547c3e5d7e | 1 | 2021-04-08 |
| 68516-5216-8 | ML - Milliliter | 68516-5216 | 55098e5b-4a23-4086-a3a5-6980a9a1e037 | 1 | 2021-04-08 |
| 68516-5216-9 | ML - Milliliter | 68516-5216 | b4707c3a-a7fd-4783-b676-b5e9773fbec8 | 1 | 2022-04-06 |
DailyMed Socrata Ingredients#
| 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55806cb8-cf92-c4e5-e063-6394a90aaa2d | 2026-06-30 | Warnings | 451W47IQ8X |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 5581d8e5-4105-e9da-e063-6394a90a316e | 2026-06-30 | Warnings | 451W47IQ8X |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37dead3e-60cb-88ae-e063-6294a90a8f70 | 2026-06-24 | Warnings | 059QF0KO0R |
| MCAS Support | APIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENS | Deseret Biologicals, Inc. | af3d5f8f-6f24-4045-8730-c776ff54bcc4 | 2026-06-24 | Warnings | 451W47IQ8X |
| Bacteriostatic Water | BACTERIOSTATIC WATER | Fujian Genohope Biotech Ltd. | 54f66b82-c9e5-a2bc-e063-6394a90adbbc | 2026-06-23 | 059QF0KO0R | |
| Humalog | INSULIN LISPRO | Eli Lilly and Company | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f | 2026-06-16 | Warnings, Adverse reactions | 059QF0KO0R |
| 0.9% Sodium Chloride Saline Solution | SODIUM CHLORIDE | Yunqi Cosmetics (Shenzhen) Co., Ltd | 546af257-dbd1-11fc-e063-6394a90a8e0a | 2026-06-16 | Warnings | 451W47IQ8X |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | BM Private Limited | 53f9c99a-0f20-0358-e063-6394a90af4e0 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5448c76a-2ecb-9402-e063-6294a90a6ad7 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b66c4-49df-556f-e063-6394a90af3ed | 2026-06-15 | Warnings | 451W47IQ8X |
| Male Support | AGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 29cefc89-3bb6-484e-84ab-116b5827a4c3 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5410ec88-8c65-3b26-e063-6294a90adf07 | 2026-06-12 | Warnings | 451W47IQ8X |
| BM BM70 DROPS | ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 54113d1f-e8e7-6b4c-e063-6394a90a0edf | 2026-06-12 | Warnings | 059QF0KO0R |
| V HP | ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUR | Energique, Inc. | ea12ca3b-19e0-4d4a-9514-4d28d214e1e7 | 2026-06-12 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 107af8bc-b6af-4b85-8c8a-ea757dcef1da | 2026-06-12 | Adverse reactions | 451W47IQ8X |
| BM BM70 DROPS | ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB | BM Private Limited | 53fa21d9-1f80-2e69-e063-6394a90ab9f3 | 2026-06-11 | Warnings | 059QF0KO0R |
| Jacksons Cell Salts DIGESTIVE BALANCE | NAT MUR, NAT PHOS, NAT SULPH | Zettl Health Inc. | 54018d0e-372f-8afc-e063-6394a90aeb15 | 2026-06-11 | Warnings | 451W47IQ8X |
| GUNA-ALLERGY T | AMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OPERCULATA - MANGANESE GLUCONATE - ONION - SCHOENOCAULON OFFICINALE SEED - SODIUM CHLORIDE - SUS SCROFA ADRENAL GLAND - SUS SCROFA BRONCHUS - SUS SCROFA NASAL MUCOSA - | Guna spa | fddba85e-2bec-468f-a01a-b71a3aeed9d3 | 2026-06-10 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO16 | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d2c34e-fa4d-9240-e063-6294a90a28da | 2026-06-09 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.