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 10 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Headache and Migraine Relief	BELLADONNA, BRYONIA, CAPSICUM ANNUUM, GELSEMIUM, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM, NATRUM MURIATICUM, NICCOLUM METALLICUM, NUX VOMICA, SANGUINARIA, SECALE CORNUTUM, SPIGELIA ANTH AND SULPHUR.	King Bio Inc.	efbfd58c-f3a6-4734-a37f-9f58fded990a	2026-03-06	Warnings	Exact identifier unii: 451W47IQ8X
Grain and Wheat	ADRENALINUM, AVENA SATIVA, BRYONIA (ALBA), GLYCINE MAX (SOY), HISTAMINUM HYDROCHLORICUM, BARLEY, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RYE, WHEAT, CORN	NaturalCare	3bd8e473-9aac-4a0c-9117-1f1488a75b7b	2026-03-03	Warnings	Exact identifier unii: 451W47IQ8X
Thyroid Support	CALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)	NaturalCare	75648609-288c-4988-8b96-46f52d639bd3	2026-03-03	Warnings	Exact identifier unii: 451W47IQ8X
Allergy Relief Indoor and Outdoor	ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NAPHTHALINUM, NATRUM MURIATICUM, SABADILLA, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, AND WYETHIA HELENIOIDES.	King Bio Inc.	9faa963e-4ddc-461f-95a1-2d10e1260612	2026-03-02	Warnings	Exact identifier unii: 451W47IQ8X
Libidotone	ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, AGNUS CASTUS, AVENA SATIVA, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, HYPOPHYSIS SUIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, SEPIA	Energique, Inc.	4ceacaa0-0219-421a-8fff-c1784c3d0f70	2026-02-27	Warnings	Exact identifier unii: 451W47IQ8X
911 Adrenal Burnout and Fatigue	ACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.	King Bio Inc.	21c6b6c1-e846-4f25-a1dc-02e79d1be756	2026-02-26	Warnings	Exact identifier unii: 451W47IQ8X
Oimmal Gentle Eye Wash	SODIUM CHLORIDE	Shenzhen Shandian Jingling Technology Co., Ltd.	4bb4e59b-a43e-fa38-e063-6294a90aea71	2026-02-26	Warnings	Exact identifier unii: 451W47IQ8X
sodium chloride	SODIUM CHLORIDE	Medefil, Inc.	d1468c0f-dd4f-4d38-a84c-c1d110303965	2026-02-26	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Resentment	ADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALE	Deseret Biologicals, Inc.	f42e08d9-349e-4e53-802c-175cf17f3f2c	2026-02-26	Warnings	Exact identifier unii: 451W47IQ8X
Tricitrates	TRICITRATES	Chartwell Governmental & Specialty RX, LLC.	c4ff0407-3930-4c48-afd4-d2cb3e1b18f4	2026-02-25	Warnings, Adverse reactions	Exact identifier unii: 1Q73Q2JULR
Anti-Itch Extra Strength	CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, AND SODIUM CHLORIDE	Forces of Nature	6131d921-c772-4684-b9ea-c5c8923daaf0	2026-02-25	Warnings	Exact identifier unii: 451W47IQ8X
BM BIO28 (General Tonic)	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	BM Private Limited	38d2cff0-3550-b119-e063-6394a90a31cb	2026-02-23	Warnings	Exact identifier unii: 451W47IQ8X
Allergy Kids	URTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOT	Forces of Nature	4886109c-dd7d-40c0-911f-5f12343d8e63	2026-02-20	Warnings	Exact identifier unii: 451W47IQ8X
Allergy Maximum Strength	URTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	122ca23e-43f1-4e5c-afc2-1418b1717679	2026-02-20	Warnings	Exact identifier unii: 451W47IQ8X
Back Pain Pain Management	ARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDE	Forces of Nature	bf089347-f334-4d6d-ab58-cf7f0b16810f	2026-02-20	Warnings	Exact identifier unii: 451W47IQ8X
RHODODIUM	ACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRON	BM Private Limited	3b3bcba2-6f9e-cd94-e063-6394a90a7701	2026-02-15	Warnings	Exact identifier unii: 451W47IQ8X
Walgreens ULTRA FINE MOISTURIZING SALINE MIST	NASAL MIST	WALGREEN COMPANY	48fef521-1b1d-d0d5-e063-6394a90ac7b1	2026-02-10	Warnings	Exact identifier unii: 451W47IQ8X
Walgreens SALINE MIST	NASAL MIST	WALGREEN COMPANY	44815675-cc1d-a582-e063-6394a90ae8f6	2026-02-10	Warnings	Exact identifier unii: 451W47IQ8X
0.9 percentsaline	SODIUM CHLORIDE	Huizhou Jinsheng Medical Technology Co., Ltd	487cb4fc-2e0b-020f-e063-6294a90a4526	2026-02-03	Warnings	Exact identifier unii: 451W47IQ8X
0.9saline	SODIUM CHLORIDE	Huizhou Jinsheng Medical Technology Co., Ltd	49e76aca-ca2b-3b95-e063-6394a90a875e	2026-02-03	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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