NDC 68516-1001 - 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
- 68516-1001
- Package NDCs from labels
- 68516-1001-1
- 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-1001-1 | Profilnine | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 33 |
| 68516-1001-1 | Alphanate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 26 |
| 68516-1001-1 | Alphanate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 mL | 1 mL in 1mL | 26 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68516-1001 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip |
| 68516-1001 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.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 |
|---|---|---|---|---|---|---|
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | beda35c3-9a8b-47ad-e053-2995a90a7b1b | 2025-11-24 | Warnings | 059QF0KO0R |
| Easy Care First Aid Eyewash | WATER | Tender Corporation | a070aac8-e6d2-ef10-e053-2a95a90aa5b1 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | e07a064b-f680-405c-bbcd-24fac430951e | 2025-11-24 | Warnings | 059QF0KO0R |
| ULINE Eyewash | EYEWASH | Niagara Pharmaceuticals Inc. | 2d7f22d2-320b-6af1-e063-6294a90addc6 | 2025-11-24 | Warnings | 059QF0KO0R |
| Pur-Wash | EYEWASH | Niagara Pharmaceuticals, Inc. | 0d43b1c1-2699-37f1-e054-00144ff88e88 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 777e1559-786f-8d54-e053-2991aa0aa98d | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 7289103a-5cbf-42f4-8848-e827149a43ca | 2025-11-24 | Warnings | 059QF0KO0R |
| Natural Eyes Floaters Relief | CHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEA | TRP Company | 445dc831-195e-4b25-e063-6294a90a6efd | 2025-11-24 | Warnings | 451W47IQ8X |
| Eyewash Additive Concentrate | WATER AND PROPYLENE GLYCOL | Haws Corporation | dd168403-398c-41ff-b1df-d93e4ff39de3 | 2025-11-20 | Warnings | 059QF0KO0R |
| Vital Female Sexual Energy | AGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS | Liddell Laboratories, Inc. | 1ca43c82-62b0-4191-81a4-27f7f94109dd | 2025-11-20 | Warnings | 451W47IQ8X 94ZLA3W45F |
| Sodium Chloride | SODIUM CHLORIDE | Walgreen Company | d112a344-33cc-41d3-bae6-492631ebdba7 | 2025-11-19 | Warnings | 451W47IQ8X |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ce0c8c6f-734a-400f-9b60-a3b1e263f25f | 2025-11-18 | Warnings, Adverse reactions | 451W47IQ8X |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | fd823bef-c14c-4708-a18a-8aaa8470412f | 2025-11-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE TABLETS | Kesin Pharma Corporation | 2f107592-10c5-ef3b-e063-6394a90a7c0a | 2025-11-17 | Warnings | 451W47IQ8X |
| ALUMIZEN | GARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED. | Natural Creations, Inc. | 4760ab09-1141-4944-b840-804ae6d86d2d | 2025-11-13 | Warnings | 451W47IQ8X |
| BLISTER HP | JUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG. | Natural Creations, Inc. | e76f05e7-6d7b-4d2e-ba26-bf776bf0e657 | 2025-11-13 | Warnings | 451W47IQ8X |
| Anxiety HP | ARSENIC TRIOXIDE, CALCIUM CARBONATE, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA | Natural Creations, Inc. | 13d92246-c20e-47a8-b88f-22da876fc545 | 2025-11-13 | Warnings | 451W47IQ8X |
| ANXIETY II HP | ACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF | Natural Creations, Inc. | 02fa45a5-08e1-41ad-acd4-0f85db07e89e | 2025-11-13 | Warnings | 451W47IQ8X |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 3765c251-eb14-d60f-e063-6294a90a6a4d | 2025-11-12 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37f244fd-c02f-e66a-e063-6394a90aed81 | 2025-11-12 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.