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 26 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXTRANEAL	ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Vantive US Healthcare LLC	e18bacfe-af60-49dc-bd30-cb3c29fa16db	2025-05-07		Exact identifier unii: 451W47IQ8X
EXTRANEAL	ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Vantive US Healthcare LLC	2b327b13-a0e9-4b2c-9875-4470998e2e30	2025-05-07		Exact identifier unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSE	SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE	Vantive US Healthcare LLC	b2b780d3-26ac-4e7c-a0f2-78991bee32a8	2025-05-07		Exact identifier unii: 451W47IQ8X
Virimmune	ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2024-2025), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUM	Deseret Biologicals, Inc.	ac036ad8-6f48-4c15-b021-dc9bbb7e642e	2025-05-06	Warnings	Exact identifier unii: 451W47IQ8X
Gout Relief 3310-S	CELERY SEED MEDICAGO SATIVA WHOLE	Bispit Canada Ltd.	346f68ea-73aa-99c6-e063-6394a90af5d5	2025-05-05	Warnings	Exact identifier unii: 451W47IQ8X
Seasonal Allergy Relief	ONION, SODIUM CHLORIDE, HISTAMINE DIHYDROCHLORIDE, CUCUMBER, GALPHIMIA GLAUCA FLOWERING TOP, AND STRYCHNOS NUX-VOMICA SEED	Hyland's Inc.	101e6b80-cdae-49e5-acfb-f056448856ec	2025-04-30	Warnings	Exact identifier unii: 451W47IQ8X
Sinus Wash Packet	SODIUM BICARBONATE, SODIUM CHLORIDE	BETTER LIVING BRANDS LLC	33ee7b77-0871-4df8-e063-6394a90ac479	2025-04-29	Warnings	Exact identifier unii: 451W47IQ8X
Tricitrates	TRICITRATES	Chartwell RX, LLC	2a80ea6b-6334-4c33-a35e-a5cb2939fbcb	2025-04-28	Warnings, Adverse reactions	Exact identifier unii: 1Q73Q2JULR
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	6d43fa91-0940-437f-ba70-b2d3f977593e	2025-04-25	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID	Kesin Pharma Corporation	3140f8fe-0644-7561-e063-6394a90a2c28	2025-04-21	Adverse reactions	Exact identifier unii: 1Q73Q2JULR
NERVE TONIC	CALCIUM PHOSPHATE, IRON, POTASSIUM PHOSPHATE, UNSPECIFIED FORM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, AND SODIUM PHOSPHATE	Hyland's Inc.	c7ea84ee-5844-4b14-9792-2c45729fccab	2025-04-10	Warnings	Exact identifier unii: SE337SVY37
Nat Mur 6X	SODIUM CHLORIDE	Hyland's Inc.	dcf0e2ac-3b69-3ae4-e053-2a95a90aaf41	2025-04-10	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products BM68 Pellets	PHOSPHORUS, ARG NIT, GELSEMIUM, NAT MUR, KALI BROM, BARYTA CARB	Bestmade Natural Products	32423a04-31d1-7477-e063-6394a90aecac	2025-04-08	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Nat Mur 8x	NATRUM MURIATICUM	Bestmade Natural Products	31e0e16d-e4df-cd9a-e063-6394a90abcc1	2025-04-03	Warnings	Exact identifier unii: 451W47IQ8X
Eye Wash	WATER	CMC Group Inc.	6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561	2025-04-02	Warnings	Exact identifier unii: 059QF0KO0R
Kidneyforce-HP	ARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA	BioActive Nutritional, Inc.	0c0f0c0c-10c2-47eb-aad6-bbffb6e16799	2025-04-02	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE TABLET	Belleview Bioscience LLC	31195e8f-d4de-9e37-e063-6294a90a4156	2025-03-24	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products BIO13 Lactose Free	CALC PHOS KALI SULPH, KALI PHOS, NAT MUR	Bestmade Natural Products	303590c5-8a66-aafc-e063-6294a90a1a4e	2025-03-23	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products BIO13	CALC PHOS, KALI SULPH, KALI PHOS, NAT MUR	Bestmade Natural Products	2fffab7f-0d4b-0e96-e063-6294a90a34d8	2025-03-23	Warnings	Exact identifier unii: 451W47IQ8X
Bestmade Natural Products Nat Mur	NAT MUR	Bestmade Natural Products	e9e9a4f6-5104-3c6f-e053-2995a90a1165	2025-03-21	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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