NDC 68516-3606 - AlphaNine SD
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
- 68516-3606
- Package NDCs from labels
- 68516-3606-2
- Manufacturer
- GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA
- Effective date
- 2025-05-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 68516-3606-2 | AlphaNine SD | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1500 [iU] in 10mL | 25 |
| 68516-3606-2 | AlphaNine SD | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1500 [iU] in 10mL | 25 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-3606 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 24 | Unmatched | 20240123_3e99052d-4442-4283-8915-c9a796c77008.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| COAGULATION FACTOR IX HUMAN | ACTIVE INGREDIENT | 6U90Y1795T | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| Coagulation Factor IX Human | ACTIVE MOIETY | 6U90Y1795T | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| dextrose | INACTIVE INGREDIENT | IY9XDZ35W2 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| heparin | INACTIVE INGREDIENT | T2410KM04A | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 10 |
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 |
|---|---|---|---|---|---|---|
| terrasil Eczema and Psoriasis Severe Outbreak | GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 4d7128fb-57f1-4d0d-a83a-daef40928ecd | 2023-11-30 | Warnings | 451W47IQ8X |
| terragen HG Formula Maximum Strength | GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | e632c831-e25d-4d04-ba72-2327d25713b1 | 2023-11-30 | Warnings | 451W47IQ8X |
| Femstat C | ECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIA | Energique, Inc. | 420119ca-f2bf-40e3-9e40-00498724c228 | 2023-11-30 | Warnings | 451W47IQ8X |
| Endopar | GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS) | Energique, Inc. | 06375c3e-cc05-4450-9117-1d3dc72636eb | 2023-11-21 | Warnings | 451W47IQ8X |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8646d7ea-cf5e-607d-e053-2a91aa0aeca1 | 2023-11-14 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 86466121-7217-d053-e053-2a91aa0a8f8a | 2023-11-14 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 864669c9-5bdc-232f-e053-2a91aa0a1fc6 | 2023-11-14 | 451W47IQ8X | |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 86462e06-d221-36b7-e053-2991aa0a1d82 | 2023-11-14 | 451W47IQ8X | |
| Mineffect nasal mist | CALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM, | Kadesh Incoporation Co,Ltd | 3a29bf95-a8a3-4517-aedf-0cd4a91b349c | 2023-10-31 | Warnings | 451W47IQ8X |
| Insomnia | AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS | Liddell Laboratories, Inc. | 18c15f17-1a16-4595-9d23-20353363cd72 | 2023-10-31 | Warnings | 451W47IQ8X |
| Saline | NASAL | GERI-CARE PHARMACEUTICAL CORP | d293cc13-4043-0d58-e053-2995a90a3fbc | 2023-10-24 | Warnings | 451W47IQ8X |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8644ffef-f0ec-5c06-e053-2a91aa0ae83d | 2023-10-23 | 451W47IQ8X | |
| Aqua marina | SODIUM CHLORIDE | Boiron | 6a212a52-32be-21b8-e053-2991aa0aea2f | 2023-10-22 | 451W47IQ8X | |
| Metab | CALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A, | Nutritional Specialties, Inc. | bbed9973-238f-47c5-9a50-ac0869a7eb3a | 2023-10-09 | Warnings | 451W47IQ8X |
| Isolyte S pH 7.4 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE | B. Braun Medical Inc. | 150437b6-320e-4c69-a434-2a26a1f0b2e4 | 2023-10-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Physiolyte | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 2023-09-26 | Warnings, Adverse reactions | 451W47IQ8X |
| Allergies | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM | Newton Laboratories, Inc. | 0631d5e5-9da4-bcb7-e063-6394a90a62de | 2023-09-25 | Warnings | 451W47IQ8X |
| Epiforce P-HP | ARSENICUM ALBUM, BORAX, GRAPHITES, NATRUM MURIATICUM, SEPIA, SULPHUR | BioActive Nutritional, Inc. | 250441d1-e261-417e-9100-700368ea38fd | 2023-09-11 | Warnings | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | B. Braun Medical Inc. | a9910e09-5aea-4ee1-a35e-ae4abf8b80b4 | 2023-09-07 | Warnings, Adverse reactions | 451W47IQ8X |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.