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 |
|---|---|---|---|---|---|---|
| Universaltox | ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUM | BioActive Nutritional, Inc. | ad454e8a-4f78-4aac-90d9-a3f26a6fbe42 | 2026-03-17 | Warnings | 451W47IQ8X |
| TINTED SUNSCREEN FOUNDATION | TINTED SUNSCREEN FOUNDATION | Guanghzou AiXin Biotech Co Ltd | 396393c4-b50c-3877-e063-6294a90a0e9b | 2026-03-17 | Warnings | 059QF0KO0R |
| BM BIO27 | CALC PHOS, KALI PHOS, NAT MUR | BM Private Limited | 4d229815-05f4-27c5-e063-6394a90ac865 | 2026-03-16 | Warnings | 451W47IQ8X |
| BM BIO1 | CALC PHOS, FERR PHOS, KALI PHOS, NAT MUR | BM Private Limited | 4d265d99-fdbb-5efb-e063-6394a90a89ac | 2026-03-16 | Warnings | 451W47IQ8X |
| BM BIO16 | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR. | BM Private Limited | 4d26b4a9-ee27-6915-e063-6294a90a5d4d | 2026-03-16 | Warnings | 451W47IQ8X |
| BM BIO12 | FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR. | BM Private Limited | 4d2747ad-958e-63a1-e063-6294a90aea66 | 2026-03-16 | Warnings | 451W47IQ8X |
| RESP EASE | SODIUM CHLORIDE | Venture Healthcare Ltd | 31b812c9-fb0a-5ee0-e063-6294a90a03e1 | 2026-03-16 | Warnings | 451W47IQ8X |
| RESP EASE | SODIUM CHLORIDE | Venture Healthcare Ltd | 31b88e7c-eca0-5540-e063-6294a90a1b18 | 2026-03-16 | Warnings | 451W47IQ8X |
| RESP EASE | SODIUM CHLORIDE | Venture Healthcare Ltd | 31b8c3f4-e528-c69d-e063-6294a90a5a34 | 2026-03-16 | Warnings | 451W47IQ8X |
| RESP EASE | SODIUM CHLORIDE | Laboratoire Unither | 31b7eb13-39c3-6f0e-e063-6394a90a4011 | 2026-03-16 | Warnings | 451W47IQ8X |
| RESP EASE | SODIUM CHLORIDE | Laboratoire Unither | 31b8bb9c-d30f-152f-e063-6394a90a5208 | 2026-03-16 | Warnings | 451W47IQ8X |
| RESP EASE | SODIUM CHLORIDE | Laboratoire Unither | 31b8dcbd-9e6b-1edc-e063-6394a90aac73 | 2026-03-16 | Warnings | 451W47IQ8X |
| BM BIO20 | CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULF | BM Private Limited | 4d285396-9df8-86bc-e063-6294a90ad4de | 2026-03-16 | Warnings | 451W47IQ8X |
| HZ HP | LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, RHUS TOX, SEPIA, THUJA OCCIDENTALIS | BioActive Nutritional, Inc. | b662dea8-4eb5-4c80-a5ab-7d3688732773 | 2026-03-13 | Warnings | 451W47IQ8X |
| Drop20 | FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE) | Pick Enterprises Corp | baa96813-dc95-472e-a834-880a0cd484a7 | 2026-03-13 | Warnings | 451W47IQ8X |
| Appetrol 20 | FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE) | Carbalor LLC | d66234a3-2477-42be-8f7b-283e3a5f87ed | 2026-03-12 | Warnings | 451W47IQ8X |
| BEE VENOM SKIN FIRMING Cream | BEE VENOM | Guangzhou Mizi Biotechnology Co., LTD. | 4ccf576f-b6bb-42ac-e063-6294a90a3652 | 2026-03-12 | Warnings | 94ZLA3W45F |
| Constitutional Enhancer | ACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR. | King Bio Inc. | 448becd7-58aa-40ae-9b4b-39f48a8f13dd | 2026-03-10 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Hospira, Inc. | 018a8807-1331-41c3-4889-c7ec502a9043 | 2026-03-09 | Warnings, Adverse reactions | 451W47IQ8X |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c7f645-cfb3-6db1-e063-6394a90a42ff | 2026-03-06 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.