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 |
|---|---|---|---|---|---|---|
| Oimmal Gentle Eye Wash | SODIUM CHLORIDE | Shenzhen Shandian Jingling Technology Co., Ltd. | 4bb4e59b-a43e-fa38-e063-6294a90aea71 | 2026-02-26 | Warnings | 451W47IQ8X |
| sodium chloride | SODIUM CHLORIDE | Medefil, Inc. | d1468c0f-dd4f-4d38-a84c-c1d110303965 | 2026-02-26 | Warnings, Adverse reactions | 451W47IQ8X |
| Resentment | ADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALE | Deseret Biologicals, Inc. | f42e08d9-349e-4e53-802c-175cf17f3f2c | 2026-02-26 | Warnings | 451W47IQ8X |
| Anti-Itch Extra Strength | CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, AND SODIUM CHLORIDE | Forces of Nature | 6131d921-c772-4684-b9ea-c5c8923daaf0 | 2026-02-25 | Warnings | 451W47IQ8X |
| BM BIO28 (General Tonic) | 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 | 38d2cff0-3550-b119-e063-6394a90a31cb | 2026-02-23 | Warnings | 451W47IQ8X |
| Allergy Kids | URTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOT | Forces of Nature | 4886109c-dd7d-40c0-911f-5f12343d8e63 | 2026-02-20 | Warnings | 451W47IQ8X |
| Allergy Maximum Strength | URTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDE | Forces of Nature | 122ca23e-43f1-4e5c-afc2-1418b1717679 | 2026-02-20 | Warnings | 451W47IQ8X |
| Back Pain Pain Management | ARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDE | Forces of Nature | bf089347-f334-4d6d-ab58-cf7f0b16810f | 2026-02-20 | Warnings | 451W47IQ8X |
| RHODODIUM | ACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRON | BM Private Limited | 3b3bcba2-6f9e-cd94-e063-6394a90a7701 | 2026-02-15 | Warnings | 451W47IQ8X |
| Walgreens ULTRA FINE MOISTURIZING SALINE MIST | NASAL MIST | WALGREEN COMPANY | 48fef521-1b1d-d0d5-e063-6394a90ac7b1 | 2026-02-10 | Warnings | 451W47IQ8X |
| Walgreens SALINE MIST | NASAL MIST | WALGREEN COMPANY | 44815675-cc1d-a582-e063-6394a90ae8f6 | 2026-02-10 | Warnings | 451W47IQ8X |
| 0.9 percentsaline | SODIUM CHLORIDE | Huizhou Jinsheng Medical Technology Co., Ltd | 487cb4fc-2e0b-020f-e063-6294a90a4526 | 2026-02-03 | Warnings | 451W47IQ8X |
| 0.9saline | SODIUM CHLORIDE | Huizhou Jinsheng Medical Technology Co., Ltd | 49e76aca-ca2b-3b95-e063-6394a90a875e | 2026-02-03 | Warnings | 451W47IQ8X |
| 0.9%saline | SODIUM CHLORIDE | Huizhou Jinsheng Medical Technology Co., Ltd | 49e7b329-e4e5-6991-e063-6294a90ac817 | 2026-02-03 | Warnings | 451W47IQ8X |
| Adrenal Support | ADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUM | NaturalCare | cee52757-a86e-4251-b65f-954ac85f4e7e | 2026-01-30 | Warnings | 451W47IQ8X |
| Vital Female Sexual Energy | AGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALIS | Liddell Laboratories, Inc. | 7b15d6fa-eb04-41d2-8a01-6e7408ccf4d3 | 2026-01-30 | Warnings | 451W47IQ8X |
| Additive Formula 3 | DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE | Terumo BCT, Ltd | 9a5247a1-cc05-442d-b2d0-950f887f03c2 | 2026-01-30 | Warnings, Adverse reactions | 451W47IQ8X |
| CVS ULTRA FINE MOISTURIZING SALINE MIST | NASAL MIST | CVS | 44821c47-63f9-5d0a-e063-6394a90a555d | 2026-01-29 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Nephron Pharmaceuticals Corporation | a4edf2d5-a9ff-30d4-e053-2995a90a5650 | 2026-01-26 | Warnings, Adverse reactions | 451W47IQ8X |
| INSULIN DILUTING MEDIUM FOR Kirsty | WATER | Biocon Biologics Inc. | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 2026-01-20 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.