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 19 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM CHLORIDE	SODIUM CHLORIDE	Hospira, Inc.	af6aebad-ef03-4d19-9a40-18e5a278b812	2025-11-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Anti Nausea Liquid	PHOSPHORATED CARBOHYDRATE	TOPCO ASSOCIATES LLC	fd0e8feb-89b5-42ff-806a-55b7473cf587	2025-11-10	Warnings	Exact identifier unii: IY9XDZ35W2
GURUNANDA NASAL SALINE	NASAL WASH	GURUNANDA LLC	27dbf0bf-c273-2108-e063-6394a90a0a09	2025-11-10	Warnings	Exact identifier unii: 451W47IQ8X
AZO Yeast Plus	CANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFUR	i-Health, Inc.	22845cac-8011-4ea8-b35e-b72973eddb44	2025-11-07	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Henry Schein, Inc.	2e81ffca-05c6-4fa0-8911-4b3cbfa71351	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Rising Pharma Holdings, Inc.	42870188-b1d7-4934-a6c0-310530497dac	2025-11-07	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	d8b8d796-bfba-42af-a859-99d776871558	2025-11-07	Adverse reactions	Exact identifier unii: 451W47IQ8X
STERILE WATER	WATER	Henry Schein, Inc.	f4087143-9868-4308-b96c-43657ee8ec28	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	31188cdf-7bc8-4d78-bfaf-c1dc9f851fd4	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
AS-3	AS-3	GVS TM INC	3dfa3397-fc13-4659-e063-6394a90a5abc	2025-11-06	Warnings	Exact identifier unii: IY9XDZ35W2
CP2D	CP2D	GVS TM INC	3fa2e438-2ff0-a2df-e063-6394a90ac7b5	2025-11-06	Warnings	Exact identifier unii: IY9XDZ35W2
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	d3d29c8f-c326-4097-814a-7f4e08c67068	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	01721071-af03-4894-95c1-10b8bc64b888	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose in Lactated Ringers	DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	190da07e-a616-46e6-b4e5-1c0ba39306e5	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	f6d82772-638c-4584-b9d3-8833669f5963	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Bacteriostatic Water	BACTERIOSTATIC WATER	ProPharma Distribution	42c6938e-f747-ae13-e063-6294a90a59a3	2025-11-04	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Com-Pare2 Dual Yeast Relief Plus Multi-symptom Formula	CANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHUR	TRP Company	42b6b9b9-a673-0bba-e063-6394a90a8866	2025-11-03	Warnings	Exact identifier unii: 451W47IQ8X
Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE	ICU Medical Inc.	5b426208-f090-4650-86c3-89040ba45c2d	2025-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4QD397987E unii: 94ZLA3W45F
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	ICU Medical Inc.	d8ee14e9-6733-4813-9f21-2b043a5f7188	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	ICU Medical Inc.	4555b1bf-6d97-4798-a63d-6d34291c85ce	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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