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 15 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Eye Wash	PURIFIED WATER	Rite Aid	28a18e04-d735-a511-e063-6394a90af6bb	2025-12-30	Warnings	Exact identifier unii: 059QF0KO0R
OCUFRESH	WATER	Optics Laboratory Inc.	b8e477a9-66b9-496b-92fb-3d4bbd7b36b5	2025-12-29	Warnings	Exact identifier unii: 059QF0KO0R
Kollourion Eyesalve Eyewash	PURIFIED WATER 98.3%	Miracle Eye Pharmaceuticals	b56d2ab9-169b-b490-e053-2a95a90a80b3	2025-12-28	Warnings	Exact identifier unii: 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	Exact identifier unii: 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	Exact identifier unii: 451W47IQ8X
Normal Salt	SODIUM CHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	f3f09817-8a38-4aa1-956b-69d9cf695074	2025-12-25	Warnings	Exact identifier unii: 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	Exact identifier unii: 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	Exact identifier unii: 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	Exact identifier unii: 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	Exact identifier unii: 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	Exact identifier unii: 451W47IQ8X
Sterile Cord Blood Collection Unit (MSC128D)	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION	Maco Productions	251fd4cb-4aa4-4473-9f89-968da856eb77	2025-12-18	Warnings	Exact identifier unii: 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	Exact identifier unii: 451W47IQ8X
Sterile Cord Blood Collection Unit (MSC127D)	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION	Maco Productions	75a008b2-9666-4bfa-ab18-6d09b43b2215	2025-12-18	Warnings	Exact identifier unii: 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	Exact identifier unii: 1Q73Q2JULR
Sterile Water	WATER	ProPharma Distribution	386a0a2f-4ff7-f128-e063-6294a90a7d4d	2025-12-18	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	ProPharma Distribution	3f79fb8b-d0e8-db2a-e063-6394a90ac136	2025-12-18	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Body Balance	ARALIA QUIN, ARNICA, AVENA, CARDUUS MAR, ELAEIS, GLANDULA SUPRARENALIS SUIS, NAT MUR, PHOSPHORICUM AC, THUJA OCC	Eight and Company L.L.C	876cc0cf-c7a7-4656-adf9-1eff9bb62687	2025-12-18	Warnings	Exact identifier unii: 451W47IQ8X
ADRENOPLEX	CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS BOVINE, SPLEEN (SUIS), CARDUUS MARIANUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM	BioActive Nutritional, Inc.	3c53c23e-7654-4e46-acf1-edb0d605ff3b	2025-12-18	Warnings	Exact identifier unii: 451W47IQ8X
Vermasode	ARTEMISIA VULGARIS, CHELIDONIUM MAJUS, GRANATUM, SPIGELIA ANTHELMIA, RATANHIA, ARSENICUM ALBUM, FERRUM METALLICUM, CALCAREA CARBONICA, CINA, GAERTNER BACILLUS, GRAPHITES, MERCURIUS DULCIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, VERMIN NOSODE	Natural Creations, Inc	180b5641-5692-42d4-8472-fdadccebd746	2025-12-18	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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