NDC 68516-1002-2 - Alphanate
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
- 68516-1002
- Requested NDC
- 68516-1002-2
- Package NDCs from labels
- 68516-1002-2
- Manufacturer
- GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | Grifols Therapeutics LLC
- Effective date
- 2026-08-25
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Alphanate - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | Grifols Therapeutics LLC | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | Grifols Therapeutics LLC | 2026-08-25 | PLASMA DERIVATIVE |
| Factor IX Complex Profilnine ® | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2026-04-01 | PLASMA DERIVATIVE |
| dextrose - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA | 2025-05-27 | PLASMA DERIVATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-1002-2 | Profilnine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 33 |
| 68516-1002-2 | Profilnine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 33 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | Alphanate | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 26 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
| 68516-1002-2 | AlphaNine SD | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 25 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-1002 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip |
| 68516-1002 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip |
| 68516-1002 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 24 | Unmatched | 20240123_3e99052d-4442-4283-8915-c9a796c77008.zip |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| EyeClear Pro | CALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEA | Silver Star Brands | f4d4943b-cb78-aa71-e053-2a95a90ac638 | 2023-02-16 | Warnings | 451W47IQ8X |
| CellTropin | ARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUS | Micro Balance Health Products LLC | 502d3ffa-bbf4-403a-9fad-b6b229f36a8c | 2023-02-14 | Warnings | 94ZLA3W45F |
| POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES | Novel Laboratories, Inc. | 29d821ff-389c-41fb-8a27-89bd3f022b82 | 2023-02-08 | Warnings, Adverse reactions | 451W47IQ8X |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 86463b98-58f5-7f65-e053-2a91aa0ad3a2 | 2023-01-23 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8645f130-6a19-ae73-e053-2991aa0ab05b | 2023-01-23 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8645eb60-65d1-9d6c-e053-2991aa0a94ef | 2023-01-23 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8644ffef-f0e6-5c06-e053-2a91aa0ae83d | 2023-01-23 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 86466614-b8ee-2335-e053-2a91aa0aa67c | 2023-01-23 | 451W47IQ8X | |
| Rehydrate | AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN | ParaDocs All Natural, Inc. | 648fab10-c46b-420f-a42c-6642009d83fb | 2023-01-10 | Warnings | 059QF0KO0R |
| PSORIASIS | ARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUM | Zorex International | b5b8bb82-4d36-4faa-b023-e48066f4521c | 2023-01-09 | Warnings | 451W47IQ8X |
| Virimmune | ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), GINKGO BILOBA, VISCUM ALBUM, HAMAMELIS VIRGINIANA, ACONITUM NAPELLUS, ALLIUM CEPA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, GELSEMIUM SEMPERVIRENS, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, INFLUENZINUM (2021-2022), MORBILLINUM | Deseret Biologicals, Inc. | 56555cb5-89e5-4a30-8ebe-ce2c01bdd426 | 2023-01-03 | Warnings | 451W47IQ8X |
| AILGENO | AMANITA MUSCARIA FRUITING BODY, ARSENIC TRIOXIDE, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, GLECHOMA HEDERACEA FLOWERING TOP, GRINDELIA HIRSUTULA WHOLE, AND SODIUM CHLORIDE | PEKANA Naturheilmittel GmbH | 4e24f727-4c83-46b6-9549-8f66bd135647 | 2022-12-21 | Warnings | 451W47IQ8X |
| Weight Management HP | ARSENIC TRIOXIDE, GOLD, OYSTER SHELL CALCIUM CARBONATE, CRUDE, IODINE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SULFUR | Natural Creations, Inc. | 93736f0b-a419-4b90-84b0-f27e4c71299b | 2022-12-20 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Liebel-Flarsheim Company LLC | e4540d03-06b4-4b4d-b859-75c13e5c20dd | 2022-12-20 | Warnings, Adverse reactions | 451W47IQ8X |
| FERRUM PHOSPHATE | SODIUM PHOSPHATE | Hyland's Inc. | c114cbad-11ed-4b1c-8ee0-33327c0e1718 | 2022-12-19 | Warnings | SE337SVY37 |
| NATRUM MURIATICUM | SODIUM CHLORIDE | Hyland's Inc. | 21ee53eb-b41a-4d2e-8037-12973d2b73d9 | 2022-12-19 | Warnings | 451W47IQ8X |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 4df47f14-8268-4cd3-b29e-96446743e2f6 | 2022-12-16 | Warnings | 451W47IQ8X |
| Cold and Cough | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Wal-Mart Stores, Inc. | 69349b4d-6c5b-7121-e053-2991aa0a3594 | 2022-12-15 | Warnings | 451W47IQ8X |
| Childrens Cold and Cough Nighttime | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL | Walgreen Company | 80c41b65-0411-4395-e053-2a91aa0a9df9 | 2022-12-15 | Warnings | 451W47IQ8X |
| Childrens Cold and Cough | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Walgreen Company | 80b5f707-a839-7729-e053-2991aa0a1c56 | 2022-12-15 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.