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 |
|---|---|---|---|---|---|---|
| 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 |
| Rite Aid Eye Wash | PURIFIED WATER | Rite Aid | 28a18e04-d735-a511-e063-6394a90af6bb | 2025-12-30 | Warnings | 059QF0KO0R |
| OCUFRESH | WATER | Optics Laboratory Inc. | b8e477a9-66b9-496b-92fb-3d4bbd7b36b5 | 2025-12-29 | Warnings | 059QF0KO0R |
| Kollourion Eyesalve Eyewash | PURIFIED WATER 98.3% | Miracle Eye Pharmaceuticals | b56d2ab9-169b-b490-e053-2a95a90a80b3 | 2025-12-28 | Warnings | 059QF0KO0R |
| Triple Allergy Defense | ALLIUM CEPA, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, LEMNA MINOR, LUFFA OPERCULATA, NATRUM MURIATICUM, POLYPORUS PINICOLA, SABADILLA | Nenningers Naturals, LLC | e1459ef4-6980-4b2b-94c1-6c896a9cb6bd | 2025-12-25 | Warnings | 451W47IQ8X |
| Dr. Nenninger Cold and Sinus Solution | ALLIUM CEPA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA | Nenningers Naturals, LLC | 1e26b25c-5d93-4f69-aa9e-a187abd6d035 | 2025-12-25 | Warnings | 451W47IQ8X |
| Normal Salt | SODIUM CHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | f3f09817-8a38-4aa1-956b-69d9cf695074 | 2025-12-25 | Warnings | 451W47IQ8X |
| ActivMend | ARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENS, NATRUM MURATICUM | Cearna, Inc. | baefc5d4-a7e4-4ba2-e053-2995a90a4b86 | 2025-12-23 | Warnings | 451W47IQ8X |
| Kids Cold and Cough Daytime | CALCIUM SULFIDE,GOLDENSEAL,ONION,PHOSPHORUS,PULSATILLA VULGARIS, SODIUM CHLORIDE | Hyland's Consumer Health Inc. | e6118c79-b6d5-5c09-e053-2a95a90a30cf | 2025-12-19 | Warnings | 451W47IQ8X |
| 4 KIDS COLD N COUGH GRAPE FLAVOR | ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFUR | Hyland's Inc. | 798e2a4d-da2d-4bbd-a9b8-574490ef7357 | 2025-12-19 | Warnings | 451W47IQ8X |
| 4 Kids Cold and Cough Daytime | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Hyland's Inc. | 804e0e7a-20eb-128b-e053-2991aa0aa82c | 2025-12-19 | Warnings | 451W47IQ8X |
| 4 Kids Cold and Cough Nighttime Natural Grape Flavor | ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN | Hyland's Inc. | 7923e59a-f62c-44df-e053-2991aa0afc1e | 2025-12-19 | Warnings | 451W47IQ8X |
| Sterile Cord Blood Collection Unit (MSC128D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Maco Productions | 251fd4cb-4aa4-4473-9f89-968da856eb77 | 2025-12-18 | Warnings | 1Q73Q2JULR |
| Hair and Nail Tonic | AVENA, DNA, ELAEIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS, HEPAR SUIS, KALI SULPH, NAT MUR, NICOTINAMIDUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, THUJA OCC, THYROIDINUM, URTICA UR. | Eight and Company L.L.C | 35bda785-b3a7-4928-aaea-27bf9fb6abb5 | 2025-12-18 | Warnings | 451W47IQ8X |
| Sterile Cord Blood Collection Unit (MSC127D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Maco Productions | 75a008b2-9666-4bfa-ab18-6d09b43b2215 | 2025-12-18 | Warnings | 1Q73Q2JULR |
| Pall Sterile Cord Blood Collection Unit | STERILE CORD BLOOD COLLECTION UNIT | Global Life Sciences Solutions USA LLC | aa9340b7-cc63-e17d-e053-2a95a90ad4d9 | 2025-12-18 | Warnings | 1Q73Q2JULR |
| Sterile Water | WATER | ProPharma Distribution | 386a0a2f-4ff7-f128-e063-6294a90a7d4d | 2025-12-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | ProPharma Distribution | 3f79fb8b-d0e8-db2a-e063-6394a90ac136 | 2025-12-18 | Warnings, Adverse reactions | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.