NDC 68516-1002 - 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
- 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 |
|---|---|---|---|---|---|---|
| Bestmade Natural Products Bio6 | FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPH | Bestmade Natural Products | ea233792-038f-39e7-e053-2995a90a20ad | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio11 | FERR PHOS, KALI MUR, KALI SULF, NAT MUR, NAT SULF | Bestmade Natural Products | eaa202d7-4297-57ba-e053-2995a90a0295 | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio12 | FERR PHOS, NAT MUR, KALI PHOS, MAG PHOS | Bestmade Natural Products | eab251db-c69a-572d-e053-2a95a90ab3a0 | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio13 | CALC PHOS, KALI SULF, KALI PHOS, NAT MUR | Bestmade Natural Products | eab2e339-c9e9-3048-e053-2995a90ae149 | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio16 | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR | Bestmade Natural Products | eac26053-7c65-7c56-e053-2995a90a8e64 | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio20 | CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULF | Bestmade Natural Products | eb3b0d9d-5f1c-8a3b-e053-2a95a90a0e1f | 2025-01-22 | Warnings | 451W47IQ8X |
| Bestmade Natural Products Bio27 | MAG PHOS, CALC PHOS, KALI PHOS, CALC FLUOR | Bestmade Natural Products | eb420652-ec68-6b46-e053-2995a90af98c | 2025-01-22 | Warnings | 451W47IQ8X |
| ACD A | DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE | Terumo BCT Ltd | 570770de-9b48-4fc1-a1ee-06002ca9504f | 2025-01-22 | 1Q73Q2JULR | |
| Anticoagulant Citrate Dextrose (ACD-A) | DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATE | Terumo BCT, Ltd | 0130d7c8-d067-4528-beb7-166559c33be9 | 2025-01-21 | Warnings, Adverse reactions | 1Q73Q2JULR |
| PTS/Stress Remedy | ACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANA | Deseret Biologicals, Inc. | 61111d6e-2480-4e89-bb0e-d712f044bdc7 | 2025-01-20 | Warnings | 451W47IQ8X |
| Medics Choice Soothing Eye Wash | PURIFIED WATER | KC Pharmaceuticals, Inc. | 10e49808-161e-f4ec-e063-6294a90a1775 | 2025-01-19 | Warnings | 059QF0KO0R |
| Metox | ALLIUM SATIVUM, ARSENICUM ALBUM, ASCORBICUM ACIDUM, BERBERIS VULGARIS, BORON, CARBOLICUM ACIDUM, CYSTEINUM, FORMALINUM, GLYCYRRHIZA GLABRA, LANTHANUM METALLICUM, LAPPA MAJOR, L-METHIONINE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NIOBIUM METALLICUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLUMBUM METALLICUM, STILLINGIA SYLVATICA, TANTALUM METALLICUM, THYROIDINUM (SUIS), TRIFOLIUM PRATENSE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, | Deseret Biologicals, Inc. | deeae030-c266-44ab-8bc7-32c3292c7247 | 2025-01-17 | Warnings | 451W47IQ8X |
| Sodium Chloride Hypertonicity Ophthalmic Solution, 5% | SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5% | Reliable 1 Laboritories LLC | 29175c17-223e-5e92-e063-6294a90a71d2 | 2025-01-15 | Warnings | 451W47IQ8X |
| D-43 | ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATE | DNA Labs, Inc. | 937e2b7e-4001-402f-bd12-dcff4627e928 | 2025-01-13 | Warnings | 451W47IQ8X |
| D-78 | HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJOR | DNA Labs, Inc. | d62673a9-8a67-4580-a8bf-25f85960a555 | 2025-01-13 | Warnings | 451W47IQ8X |
| D-86 | ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDE | DNA Labs, Inc. | 54fa62d3-c129-4826-a794-f3dcc6b855bf | 2025-01-13 | Warnings | 451W47IQ8X |
| D-98 | STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARK | DNA Labs, Inc. | 9b39b277-9eb2-44c9-9c0c-a8680a50e18d | 2025-01-13 | Warnings | 451W47IQ8X |
| D-129 | SODIUM CHLORIDE | DNA Labs, Inc. | ef130f08-1c34-4774-9298-2d1997e631fc | 2025-01-13 | Warnings | 451W47IQ8X |
| D-50 | HORSE CHESTNUT, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, AND STRONTIUM CARBONATE | DNA Labs, Inc. | df118b9b-dee7-4555-bcae-751007c1fd2c | 2025-01-13 | Warnings | 451W47IQ8X |
| D-68 | CROTON OIL, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, AND TOXICODENDRON PUBESCENS LEAF | DNA Labs, Inc. | 01ae098b-aadd-4edc-bf73-6bc60903e779 | 2025-01-13 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.