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 |
|---|---|---|---|---|---|---|
| Sodium chloride | SODIUM CHLORIDE | BECTON DICKINSON AND COMPANY | d39b7307-df67-4e68-acb0-2eda5dc61215 | 2026-01-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Eye Clean | EYE WASH | HART Health | 41f53e2e-c2bc-4bf1-a541-3bcb2cf63002 | 2025-12-31 | Warnings | 059QF0KO0R |
| Immune Boost | CHERRY PLUM, FERR PHOS, HORNBEAM, KALI SULPH, NAT MUR, OAK, OLIVE, THYMUS (CALF), ZINC MUR | Siddha Flower Essences LLC | e8d44b65-47ef-ebc7-e053-2995a90a8583 | 2025-12-31 | Warnings | 451W47IQ8X |
| emotional detox | CALC PHOS, CALC SULPH, CASTANEA SATIVA, FLOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPAEA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS | Siddha Flower Essences LLC | 385fb878-dd8f-40ae-82a3-874d6a6cceb2 | 2025-12-31 | Warnings | 451W47IQ8X |
| happy heart | BROMUS RAMOSUS, FLOS, CALC FLUOR, CENTAURIUM UMBELLATUM, FLOS, FER PHOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, MAG PHOS, NAT MUR | Siddha Flower Essences LLC | adb25966-b49a-48a9-a4ce-3ad7a2d7a712 | 2025-12-31 | Warnings | 451W47IQ8X |
| digest | AESCULUS HIPPOCASTANUM, BUD, CAL PHOS, CARPINUS BETULUS, FLOS, KALI PHOS, MAG PHOS, NAT MUR, NAT SULPH, ULMUS PROCERA, FLOS | Siddha Flower Essences LLC | 99886d33-d8e0-4f58-89fa-e5071b30a98e | 2025-12-31 | Warnings | 451W47IQ8X |
| blood sugar | CALC PHOS, CARPINUS BETULUS, FLOS, FERRUM PHOS, KALI PHOS, NAT MUR, NAT SULPH, OLEA EUROPAEA, FLOS, SILICEA, SINAPIS ARVENSIS, FLOS | Siddha Flower Essences, LLC | 90ecd62b-c4bc-4bc4-a409-219929a49edb | 2025-12-31 | Warnings | 451W47IQ8X |
| mood and patience | CALC PHOS, CALC SULPH, CARPINUS BETULUS FLOS, FER PHOS, ILEX AQUIFOLIUM FLOS, IMPATIENS GLANDULIFERA FLOS, KALI PHOS, MAG PHOS, NAT MUR, NAT SULPH | Siddha Flower Essences LLC | 03f55295-94f9-44f6-9386-ea2741a0f8be | 2025-12-31 | Warnings | 451W47IQ8X |
| sleep | AESCULUS HIPPOCASTANUM, FLOS, FERRUM PHOS, KALI CARB, KALI PHOS, MAG PHOS, NAT MUR, POPULUS TERMULA, FLOS, PRUNUS CERASIFERA, FLOS | Siddha Flower Essences LLC | dc353895-3a58-475c-8afd-ab08b27b96c3 | 2025-12-31 | Warnings | 451W47IQ8X |
| teeth and gums | CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS | Siddha Flower Essences LLC | 926c79d5-d270-4c0d-aca9-b58571c24f3a | 2025-12-31 | Warnings | 059QF0KO0R |
| throat and voice | CERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEA | Siddha Flower Essences LLC | 375ef37c-d5de-4762-a569-7304d9882520 | 2025-12-31 | Warnings | 451W47IQ8X |
| healthy hair | CERTOSTIGMA WILLMOTTIANUM, FLOS, KALI SULPH, LARIX DECIDUA, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, SILICEA | Siddha Flower Essences LLC | 2b49fb7a-8d8b-4cef-8f8d-515c54451bfd | 2025-12-31 | Warnings | 451W47IQ8X |
| grief and loss | CALC PHOS, CALC SULPH, CASTANEA SATIVA FLOS, IGNATIA AMARA, JUGLANS REGIA FLOS, KALI PHOS, NAT MUR, NAT SULPH, ORNITHOLAGUM UMBELLATUM FLOS, PHOS ACID | Siddha Flower Essences LLC | 1bb78196-303e-4c19-8bd9-d2add41ec52b | 2025-12-31 | Warnings | 451W47IQ8X |
| sight | AESCULUS HIPPOCASTANUM, BUD, BROMUS RAMOSUS, FLOS, CALC FLUORICA, CALC PHOS, CALC SULPH, CLEMATIS VITALBA, FLOS, FERRUM PHOS, MAG PHOS, NAT MUR, SILICEA | Siddha Flower Essences LLC | e6a5a50f-873e-4aa0-ad66-ccfa70c75cde | 2025-12-31 | Warnings | 451W47IQ8X |
| mind and memory | AESCULUS HIPPOCASTANUM FLOS, CALC PHOS, CALC SULPH, CLEMATIS VITALBA FLOS, KALI PHOS, MAG PHOS, NAT MUR, SCLERANTHUS ANNUUS FLOW, SILICEA | Siddha Flower Essences LLC | 0d35b9a2-2123-4c14-b0b8-f45f3820ee03 | 2025-12-31 | Warnings | 451W47IQ8X |
| energy and motivation | CALC SULPH, GENTIANA AMARELLA FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPEA FLOS, PHOS ACID, ULEX EUROPAEUS FLOS | Siddha Flower Essences LLC | aa69dd35-9866-40d7-9820-b01fc15be58a | 2025-12-31 | Warnings | 451W47IQ8X |
| lung and sinus | CALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOS | Siddha Flower Essences LLC | 9f7c949f-21bc-473c-ab8d-24837893fccc | 2025-12-31 | Warnings | 059QF0KO0R |
| youthful skin | AESCULUS HIPPOCASTANUM, BUD, AGRIMONIA EUPATORIA, FLOS, CALC FLUORICA, CALC SULPH, FERRUM PHOS, KALI SULPH, MALUS PUMILA, FLOS, NAT MUR, SILICEA | Siddha Flower Essences LLC | 6f72f1b9-d627-4110-9546-13320e62c465 | 2025-12-31 | Warnings | 451W47IQ8X |
| male balance | CENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEA | Siddha Flower Essences LLC | 61b7cfe0-1465-482b-97dd-8fbb8d420a93 | 2025-12-31 | Warnings | 451W47IQ8X |
| Quality Choice Eye Wash | WATER | Chain Drug Marketing Assoc., Inc. | 1fb8a109-351b-7039-e063-6394a90a7311 | 2025-12-30 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.