NDC 76297-002-12 - 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: 76297-002
Requested NDC: 76297-002-12
Package NDCs from labels: 76297-002-02, 76297-002-12, 76297-002-22
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
Alanine - GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2025-08-21	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
Koate - KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2023-12-13	PLASMA DERIVATIVE
Koate - KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2023-12-12	PLASMA DERIVATIVE
PROLASTIN-C - GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2022-02-25	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76297-002-02	Profilnine	5 mL in 1 VIAL, GLASS	SOLUTION	5 mL	1 mL in 1mL	33
76297-002-12	Profilnine	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	33
76297-002-12	Profilnine	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	33
76297-002-12	THROMBATE III	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	31
76297-002-02	Alphanate	5 mL in 1 VIAL, GLASS	SOLUTION	5 mL	1 mL in 1mL	26
76297-002-02	Alphanate	5 mL in 1 VIAL, GLASS	SOLUTION	5 mL	1 mL in 1mL	26
76297-002-12	Alphanate	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	26
76297-002-12	Alphanate	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	26
76297-002-12	Alphanate	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	26
76297-002-12	AlphaNine SD	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	25
76297-002-12	AlphaNine SD	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	25
76297-002-12	AlphaNine SD	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	25
76297-002-22	PROLASTIN-C	20 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	20 mL	1 mL in 1mL	25
76297-002-02	Koate	5 mL in 1 VIAL, GLASS	SOLUTION	5 mL	1 mL in 1mL	23
76297-002-02	Koate	5 mL in 1 VIAL, GLASS	SOLUTION	5 mL	1 mL in 1mL	23
76297-002-12	Koate	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	23
76297-002-02	Koate	5 mL in 1 VIAL, GLASS	SOLUTION	5 mL	1 mL in 1mL	10
76297-002-02	Koate	5 mL in 1 VIAL, GLASS	SOLUTION	5 mL	1 mL in 1mL	10
76297-002-12	Koate	10 mL in 1 VIAL, GLASS	SOLUTION	10 mL	1 mL in 1mL	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76297-002	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	29	Unmatched	20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip
76297-002	THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC]	29	Unmatched	20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip
76297-002	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	25	Unmatched	20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip
76297-002	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC]	25	Unmatched	20220308_91edab72-c889-470e-8315-1798b5548dca.zip
76297-002	ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]	24	Unmatched	20240123_3e99052d-4442-4283-8915-c9a796c77008.zip
76297-002	KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]	23	Unmatched	20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip
76297-002	KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]	10	Unmatched	20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.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
Alpha-1-proteinase Inhibitor Human	ACTIVE INGREDIENT	F43I396OIS	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Alpha-1-proteinase Inhibitor Human	ACTIVE MOIETY	F43I396OIS	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Sodium Phosphate	INACTIVE INGREDIENT	SE337SVY37	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
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
Antihemophilic Factor Human	ACTIVE INGREDIENT	839MOZ74GK	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Antithrombin Iii Human	ACTIVE INGREDIENT	T0LTO7L82X	THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]	11
Antihemophilic Factor Human	ACTIVE MOIETY	839MOZ74GK	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Antithrombin Iii Human	ACTIVE MOIETY	T0LTO7L82X	THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]	11
Albumin (human)	INACTIVE INGREDIENT	ZIF514RVZR	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Aluminum	INACTIVE INGREDIENT	CPD4NFA903	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Calcium Chloride	INACTIVE INGREDIENT	M4I0D6VV5M	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Glycine	INACTIVE INGREDIENT	TE7660XO1C	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Histidine	INACTIVE INGREDIENT	4QD397987E	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Tri-n-butyl Phosphate	INACTIVE INGREDIENT	95UAS8YAF5	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
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 1 of 58 · 1,159 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymph Tonic II	ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA	BioActive Nutritional, Inc.	0e3265b0-b210-4a4c-80d2-8a9712981d4e	2026-09-17	Warnings	Exact identifier unii: 451W47IQ8X
calcium chloride	CALCIUM CHLORIDE	Eskayef Pharmaceuticals Limited	5b0bd762-4c87-597e-e063-6394a90a8303	2026-09-09	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Saline	NASAL	Raritan Pharmaceuiticals Inc	4b178e4e-a10f-4b75-8140-1f7548e203ad	2026-09-09	Warnings	Exact identifier unii: 451W47IQ8X
Thyroid Support	CALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)	NaturalCare	07b4e0ed-2b00-4d0a-ad8f-fc6deff15325	2026-09-08	Warnings	Exact identifier unii: 451W47IQ8X
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: 451W47IQ8X
DEFENCATH	TAUROLIDINE AND HEPARIN	CorMedix Inc.	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	2026-09-04	Warnings, Adverse reactions	Exact identifier unii: T2410KM04A
KROGER Saline	NASAL	KROGER COMPANY	c84b242b-f46e-4ea8-a3c1-109a47644646	2026-09-02	Warnings	Exact identifier unii: 451W47IQ8X
Adrenal Support	ADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUM	NaturalCare	31a5d522-15cd-432a-bf87-f721bcbe2e31	2026-09-02	Warnings	Exact identifier unii: 451W47IQ8X
Kroger Anti Nausea Cherry Flavor	DEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACID	KROGER COMPANY	fb7326db-3512-45ee-9a9b-48f3ebd8d0c5	2026-09-02	Warnings	Exact identifier unii: IY9XDZ35W2
Xtreme Saline Rinse Mix	SODIUM BICARBONATE, SODIUM CHLORIDE	Xtreme Personal Care Inc	776f417e-e443-4918-8c7a-1913b7dddcd4	2026-09-01	Warnings	Exact identifier unii: 451W47IQ8X
Skin Smoothing Care	CENTELLA ASIATICA TRITERPENOIDS	Haikou Flash Purchase Star Cross-Border Trade Co., Ltd.	5a77f521-2948-6c88-e063-6394a90ad18f	2026-09-01	Warnings	Exact identifier unii: 94ZLA3W45F
Nacl 0.9% Normal Saline Solution	SODIUM CHLORIDE	CHI FUNG TECHNOLOGY COMPANY	5a53c4c8-c9de-700c-e063-6394a90a3ab5	2026-08-31	Warnings	Exact identifier unii: 451W47IQ8X
BMNP Nat Mur	NATRUM MURIATICUM	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5a57ccfd-ab6f-cb2c-e063-6394a90ae9e6	2026-08-31	Warnings	Exact identifier unii: 451W47IQ8X
Calcium Chloride	CALCIUM CHLORIDE	REMEDYREPACK INC.	801f110c-7800-4689-a37a-f31d99c0f930	2026-08-28	Adverse reactions	Exact identifier unii: M4I0D6VV5M
Allergy Care	ADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR	NaturalCare	f3ca7f5a-1448-4670-ac02-b47ffb6c5585	2026-08-27	Warnings	Exact identifier unii: 451W47IQ8X
Calcium Chloride	CALCIUM CHLORIDE INJECTION	REMEDYREPACK INC.	3089499b-142d-482e-889d-1db4da7b1152	2026-08-26	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
KUGIG ALOE FOAMING INTIMATE WASH	INTIMATE CLEANSING FOAM	Hong Kong KangXing Centennial Management Limited	59f4d398-1186-a168-e063-6294a90ab44b	2026-08-26	Warnings	Exact identifier unii: 059QF0KO0R
Saline	SALINE NASAL SPRAY	Dynarex Corporation	3247ae7d-554f-baab-e063-6294a90aa3ec	2026-08-25	Warnings	Exact identifier unii: 451W47IQ8X
Electrolyte Plus	KALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUM	Deseret Biologicals, Inc.	e3564733-8b88-4753-9077-9d74004d8ec9	2026-08-25	Warnings	Exact identifier unii: 451W47IQ8X unii: 94ZLA3W45F
Sterile Water	WATER	REMEDYREPACK INC.	5dd5d148-6e23-41de-bff5-551b2aea9598	2026-08-24	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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