NDC 76297-002-22 - 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: 76297-002-22
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 2 of 55 · 1,096 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	d5b44f79-5299-4b31-ba45-0e511cdbe17c	2026-08-24	Warnings	Exact identifier unii: 451W47IQ8X
Bio Combination 28	SCHUESSLER SALTS	LDD Bioscience Private Limited	597caf33-5107-9dec-e063-6294a90a5fcd	2026-08-20	Warnings	Exact identifier unii: 451W47IQ8X unii: SE337SVY37
Sodium Chloride	SODIUM CHLORIDE	YYBA CORP	597f3347-647c-3545-e063-6294a90abab2	2026-08-20	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e88	2026-08-20	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sinusforce-HP	ARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA	BioActive Nutritional, Inc.	53c96680-210b-4426-8b41-3b9a882848dd	2026-08-20	Warnings	Exact identifier unii: 451W47IQ8X
CVS Saline	NASAL	CVS PHARMACY	f02c41b0-c78e-41cd-aa4a-2756bbe92087	2026-08-19	Warnings	Exact identifier unii: 451W47IQ8X
TrophAmine	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINE	B. Braun Medical Inc.	cb6d23ff-3ec5-445a-acbe-f88fd57949bf	2026-08-19	Warnings, Adverse reactions	Exact identifier unii: OF5P57N2ZX unii: 4QD397987E unii: 94ZLA3W45F
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Fresenius Kabi USA, LLC	df18a603-ca12-4b26-83b5-9dd07b6453ab	2026-08-18	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
DELFLEX	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Fresenius Medical Care Renal Therapies Group, LLC	bbc5b820-4973-11e2-a192-0002a5d5c51b	2026-08-18	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
DELFLEX	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Fresenius Medical Care Renal Therapies Group, LLC	c29bdfa0-4976-11e2-939b-0002a5d5c51b	2026-08-18	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
DELFLEX	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE	Fresenius Medical Care Renal Therapies Group, LLC	515dcee0-3e34-11e2-a25f-0800200c9a66	2026-08-18	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
CVS Anti Nausea Cherry Flavor	DEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACID	CVS PHARMACY	f6f7568b-3887-434d-9403-a3ecdc591bbc	2026-08-17	Warnings	Exact identifier unii: IY9XDZ35W2
BM BM63 DROPS	CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN	BM Private Limited	59006d82-610a-2e08-e063-6394a90af1ed	2026-08-14	Warnings	Exact identifier unii: 059QF0KO0R
BM BM173 DROPS	ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN	BM Private Limited	59036ca4-e7bb-bbe7-e063-6394a90a410a	2026-08-14	Warnings	Exact identifier unii: 451W47IQ8X
Natural Lift Lack of energy - Fatigue	AVENA SATIVA 9C, GELSEMIUM SEMPERVIRENS 9C, PANAX GINSENG 3C, NATRUM MURIATICUM 9C	SEVENE USA	551194c4-dfd8-c42d-e063-6294a90aecee	2026-08-13	Warnings	Exact identifier unii: 451W47IQ8X
BM BM59 DROPS	CALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCC	BM Private Limited	58ef0755-c2cd-b7c2-e063-6294a90a2707	2026-08-13	Warnings	Exact identifier unii: 451W47IQ8X
Adrenal-Tone	ADRENALINUM, AVENA, GINKGO, GLYCYRRHIZA, KALI PHOS, NAT MUR, NUX VOMICA, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SARSAPARILLA, THYROIDINUM, VERATRUM ALB, ZINC MET.	Energetix Corporation	1ea4abb3-3a02-4d5c-baeb-d903b0febbb5	2026-08-11	Warnings	Exact identifier unii: 451W47IQ8X
Adrenapath	CARDUUS MARIANUS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM (BOVINE), THYROIDINUM (BOVINE)	Energetix Corporation	c300b8f5-4334-4597-a303-8200cbc117d1	2026-08-11	Warnings	Exact identifier unii: 451W47IQ8X
Lymph-Tone II	AESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.	Energetix Corporation	c46aa8d3-4aa5-4e07-be3d-d71abc5e2407	2026-08-11	Warnings	Exact identifier unii: 451W47IQ8X
Metabopath	ADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,	Energetix Corporation	58bfe670-d308-45a2-8046-7897b6221452	2026-08-11	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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