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 |
|---|---|---|---|---|---|---|
| AILGENO | AMANITA MUSCARIA FRUITING BODY, ARSENIC TRIOXIDE, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, GLECHOMA HEDERACEA FLOWERING TOP, GRINDELIA HIRSUTULA WHOLE, AND SODIUM CHLORIDE | PEKANA Naturheilmittel GmbH | 4e24f727-4c83-46b6-9549-8f66bd135647 | 2022-12-21 | Warnings | 451W47IQ8X |
| Weight Management HP | ARSENIC TRIOXIDE, GOLD, OYSTER SHELL CALCIUM CARBONATE, CRUDE, IODINE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SULFUR | Natural Creations, Inc. | 93736f0b-a419-4b90-84b0-f27e4c71299b | 2022-12-20 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Liebel-Flarsheim Company LLC | e4540d03-06b4-4b4d-b859-75c13e5c20dd | 2022-12-20 | Warnings, Adverse reactions | 451W47IQ8X |
| FERRUM PHOSPHATE | SODIUM PHOSPHATE | Hyland's Inc. | c114cbad-11ed-4b1c-8ee0-33327c0e1718 | 2022-12-19 | Warnings | SE337SVY37 |
| NATRUM MURIATICUM | SODIUM CHLORIDE | Hyland's Inc. | 21ee53eb-b41a-4d2e-8037-12973d2b73d9 | 2022-12-19 | Warnings | 451W47IQ8X |
| Cataracc | ARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET. | Newton Laboratories, Inc. | eff981fd-5436-7c34-e053-2a95a90a3e8e | 2022-12-16 | Warnings | 451W47IQ8X |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 4df47f14-8268-4cd3-b29e-96446743e2f6 | 2022-12-16 | Warnings | 451W47IQ8X |
| Cold and Cough | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Wal-Mart Stores, Inc. | 69349b4d-6c5b-7121-e053-2991aa0a3594 | 2022-12-15 | Warnings | 451W47IQ8X |
| Childrens Cold and Cough Nighttime | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL | Walgreen Company | 80c41b65-0411-4395-e053-2a91aa0a9df9 | 2022-12-15 | Warnings | 451W47IQ8X |
| Childrens Cold and Cough | ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL | Walgreen Company | 80b5f707-a839-7729-e053-2991aa0a1c56 | 2022-12-15 | Warnings | 451W47IQ8X |
| FERRODONNA | ARSENIC TRIOXIDE, CEANOTHUS AMERICANUS LEAF, CINCHONA OFFICINALIS BARK, COBALTOUS NITRATE, CUPRIC SULFATE, IRON, MANGANESE ACETATE, AND SODIUM CHLORIDE | PEKANA Naturheilmittel GmbH | 64c6f75a-382d-4aa0-b210-6be83a62fa3f | 2022-12-14 | Warnings | 451W47IQ8X |
| Nat Mur | SODIUM CHLORIDE | Hyland's Inc. | d3ab4254-daaf-24ac-e053-2995a90afb8f | 2022-12-13 | Warnings | 451W47IQ8X |
| NERVE TONIC STRESS RELIEF | CALCIUM PHOSPHATE, IRON, POTASSIUM PHOSPHATE, UNSPECIFIED FORM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND SODIUM PHOSPHATE | Hyland's Inc. | ec5a66df-a66c-4cdd-9685-af0a79b47bb8 | 2022-12-13 | Warnings | SE337SVY37 |
| Rest | SILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS AND VALERIAN | Hyland's Inc. | 5e9924be-4dad-324a-e053-2a91aa0a8ec1 | 2022-12-13 | Warnings | 451W47IQ8X |
| Defend Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | bb851be1-0528-4199-91e7-e09f994b2862 | 2022-12-12 | Warnings | 451W47IQ8X |
| BACTERIOSTATIC SODIUM CHLORIDE | BACTERIOSTATIC SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 7611e508-6da2-3a2f-e053-2a91aa0a9f40 | 2022-12-09 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| BACTERIOSTATIC SODIUM CHLORIDE | BACTERIOSTATIC SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 763ff805-af1a-e8e9-e053-2a91aa0a8253 | 2022-12-09 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2fae04e3-20b1-4b8c-b1fb-646b384836f1 | 2022-12-07 | Warnings, Adverse reactions | 451W47IQ8X |
| apo-STOM | ANTIMONY TRISULFIDE, ATROPA BELLA-DONNA FLOWERING TOP, COLCHICUM AUTUMNALE BULB, CITRULLUS COLOCYNTHIS FRUIT PULP, SODIUM PHOSPHATE, STRYCHNOS NUX-VOMICA SEED, ROBINIA PSEUDOACACIA BARK, AND ACHILLEA MILLEFOLIUM FLOWERING TOP | PEKANA Naturheilmittel GmbH | 5ded31e3-c7fb-473f-9f37-13ee9cad386c | 2022-12-06 | Warnings | SE337SVY37 |
| MET TOX | ARSENICUM ALB, AVENA, BERBERIS VULG, LYCOPODIUM, NAT MUR, NUX VOM, PHYTOLACCA, RHAMNUS FRANG, SOLIDAGO, TRIFOLIUM PRAT | White Manufacturing Inc. DBA Micro-West | 2653d62b-5dd7-482c-b31c-ce5fa1373900 | 2022-12-02 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.