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 |
|---|---|---|---|---|---|---|
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | 451W47IQ8X |
| Electrolyte Plus | KALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUM | Deseret Biologicals, Inc. | e3564733-8b88-4753-9077-9d74004d8ec9 | 2026-08-25 | Warnings | 451W47IQ8X 94ZLA3W45F |
| Sterile Water | WATER | REMEDYREPACK INC. | 5dd5d148-6e23-41de-bff5-551b2aea9598 | 2026-08-24 | Warnings, Adverse reactions | 059QF0KO0R |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | d5b44f79-5299-4b31-ba45-0e511cdbe17c | 2026-08-24 | Warnings | 451W47IQ8X |
| Bio Combination 28 | SCHUESSLER SALTS | LDD Bioscience Private Limited | 597caf33-5107-9dec-e063-6294a90a5fcd | 2026-08-20 | Warnings | 451W47IQ8X SE337SVY37 |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e88 | 2026-08-20 | Warnings, Adverse reactions | 451W47IQ8X |
| Sinusforce-HP | ARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA | BioActive Nutritional, Inc. | 53c96680-210b-4426-8b41-3b9a882848dd | 2026-08-20 | Warnings | 451W47IQ8X |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | 451W47IQ8X |
| TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE | B. Braun Medical Inc. | cb6d23ff-3ec5-445a-acbe-f88fd57949bf | 2026-08-19 | Warnings, Adverse reactions | 4QD397987E 94ZLA3W45F |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | bbc5b820-4973-11e2-a192-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | c29bdfa0-4976-11e2-939b-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | 515dcee0-3e34-11e2-a25f-0800200c9a66 | 2026-08-18 | Warnings, Adverse reactions | 451W47IQ8X |
| CVS Anti Nausea Cherry Flavor | DEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACID | CVS PHARMACY | f6f7568b-3887-434d-9403-a3ecdc591bbc | 2026-08-17 | Warnings | IY9XDZ35W2 |
| BM BM63 DROPS | CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN | BM Private Limited | 59006d82-610a-2e08-e063-6394a90af1ed | 2026-08-14 | Warnings | 059QF0KO0R |
| BM BM173 DROPS | ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN | BM Private Limited | 59036ca4-e7bb-bbe7-e063-6394a90a410a | 2026-08-14 | Warnings | 451W47IQ8X |
| Natural Lift Lack of energy - Fatigue | AVENA SATIVA 9C, GELSEMIUM SEMPERVIRENS 9C, PANAX GINSENG 3C, NATRUM MURIATICUM 9C | SEVENE USA | 551194c4-dfd8-c42d-e063-6294a90aecee | 2026-08-13 | Warnings | 451W47IQ8X |
| BM BM59 DROPS | CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCC | BM Private Limited | 58ef0755-c2cd-b7c2-e063-6294a90a2707 | 2026-08-13 | Warnings | 451W47IQ8X |
| Adrenal-Tone | ADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET. | Energetix Corporation | 1ea4abb3-3a02-4d5c-baeb-d903b0febbb5 | 2026-08-11 | Warnings | 451W47IQ8X |
| Adrenapath | CARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), THYROIDINUM (BOVINE) | Energetix Corporation | c300b8f5-4334-4597-a303-8200cbc117d1 | 2026-08-11 | Warnings | 451W47IQ8X |
| Lymph-Tone II | AESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC. | Energetix Corporation | c46aa8d3-4aa5-4e07-be3d-d71abc5e2407 | 2026-08-11 | Warnings | 451W47IQ8X |