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 table
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 table
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 table
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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
factor ix complex	ACTIVE INGREDIENT	FW411QXD5M	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
factor ix complex	ACTIVE MOIETY	FW411QXD5M	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
sodium phosphate	INACTIVE INGREDIENT	SE337SVY37	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX	ACTIVE INGREDIENT	5T6B772R4Q	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX	ACTIVE MOIETY	5T6B772R4Q	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
albumin (human)	INACTIVE INGREDIENT	ZIF514RVZR	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
arginine	INACTIVE INGREDIENT	94ZLA3W45F	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
histidine	INACTIVE INGREDIENT	4QD397987E	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
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.

Matched openFDA labels page 22 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Homeopathic Calm Drops	ARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30C	HISTORICAL REMEDIES LLP.	69c35bc2-b9a0-4bb4-a56d-0e2d1c3f7958	2025-10-07	Warnings	Exact identifier unii: 451W47IQ8X
Homeopathic Moon drops	ARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,	Historical Remedies LLP	0e7972a5-a930-4a52-8896-02ce810fa90b	2025-10-07	Warnings	Exact identifier unii: 451W47IQ8X
Tri-Relief Antifungal	SODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIG	Forces of Nature	6fe97b54-8aa3-4d86-9055-0629589a416b	2025-10-06	Warnings	Exact identifier unii: 451W47IQ8X
Virex	ADENOVIREN NOSODE, ASCLEPIAS TUBEROSA, CALCAREA ARSENICICA, CAMPHORA, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A5 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B4 NOSODE, COXSACKIE B5 NOSODE, CYTOMEGALOVIRUS NOSODE, ECHINACEA PURPUREA, EPSTEIN-BARR VIRUS NOSODE, EUPHRASIA OFFICINALIS, INFLUENZINUM, LAC VACCINUM, MORBILLINUM, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, TRIFOLIUM PRATENSE, VARIOLINUM	Nutritional Specialties, Inc.	4baa5c95-79a6-4ae8-a8c4-1edbf308f92c	2025-10-03	Warnings	Exact identifier unii: 451W47IQ8X
Xpect Eyewash	EYEWASH	Cintas Corporation	1d69365d-662b-4248-8fa9-1629451b549a	2025-09-30	Warnings	Exact identifier unii: 059QF0KO0R
CheBoho TEA TREE ACNE	CHEBOHO TEA TREE ACNE	Opalshi(Guangzhou)E-commerce Co. Ltd.	3fc4cf84-b2da-c593-e063-6394a90abc5c	2025-09-27	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	ProPharma Distribution	3f2ae880-852f-b45d-e063-6394a90aa1cc	2025-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Jet Lag	ECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.	Newton Laboratories, Inc.	9c21c935-4ebc-1efd-e053-2995a90aa156	2025-09-18	Warnings	Exact identifier unii: 451W47IQ8X
Perikabiven	DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE	Fresenius Kabi USA, LLC	c2eb5522-8572-45f4-869d-42f9fd251bb6	2025-09-15	Warnings, Adverse reactions	Exact identifier unii: 4QD397987E unii: 94ZLA3W45F
Kabiven	DEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE	Fresenius Kabi USA, LLC	afeb4837-a759-4484-a76e-e04611c459e7	2025-09-11	Warnings, Adverse reactions	Exact identifier unii: 4QD397987E unii: 94ZLA3W45F
GAVILYTE-N	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE	Lupin Pharmaceuticals,Inc.	27195187-75a3-431f-90d9-84da1b94e849	2025-09-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
GaviLyte - C TM	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK	Lupin Pharmaceuticals,Inc.	a8b15625-ca7c-4d57-9f36-3ac2a6d13665	2025-09-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
GAVILYTE G TM	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	Lupin Pharmaceuticals,Inc.	3978822b-6473-4072-9f80-20ceb9bea355	2025-09-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General Tonic	CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA	Martin & Pleasance Pty Ltd	9083a01b-2fbe-4e04-9eec-bf4f65950ec7	2025-09-09	Warnings	Exact identifier unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General Tonic	CALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEA	Martin & Pleasance Pty Ltd	c14c79ab-85bb-45f2-83d1-1d9c298ffdfd	2025-09-08	Warnings	Exact identifier unii: 451W47IQ8X
Medi-First First Aid Eye Wash	PURIFIED WATER	Unifirst First Aid Corporation	dcd7fe56-ff5c-4c8d-a415-6e363d7e53f4	2025-09-08	Warnings	Exact identifier unii: 059QF0KO0R
Green Guard First Aid Eye Wash	WATER	Unifirst First Aid Corporation	a4ba5526-b4e2-4bcc-9127-aa22ebf5017f	2025-09-08	Warnings	Exact identifier unii: 059QF0KO0R
Medi-First Plus First Aid Eye Wash	WATER	Unifirst First Aid Corporation	d7ea80ca-b4a0-4476-8b50-b3425c6d456a	2025-09-08	Warnings	Exact identifier unii: 059QF0KO0R
ECOLAB Eye Wash	PURIFIED WATER	ECOLAB Food Safety Specialties, Inc.	4bcfa21a-791e-4d04-e054-00144ff88e88	2025-09-08	Warnings	Exact identifier unii: 059QF0KO0R
Physicians Care Eyewash	EYEWASH	Acme United Corporation	3e239b12-9a75-339d-e063-6294a90a72ae	2025-09-06	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.