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 20 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	ICU Medical Inc.	aab10f03-26ae-4dbc-a481-ef025e48b405	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	ICU Medical Inc.	e3484bc6-ed7f-43ef-9d49-c131a8dff2dd	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	3cfdeee0-ff14-4341-8396-b11c2a037c60	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	5f372b75-d7a4-471e-8ac6-290040fc84b0	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	243fe8fc-996a-4855-8daf-069628e547c4	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	d310d170-5eeb-471b-af1a-0e845001d21d	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	009bef3c-e8ac-46be-b564-a2556adf0081	2025-10-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	237b39fa-916e-4a54-99c8-4ae9ad54f056	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Normosol-R and Dextrose	DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	ead1fca3-eff4-478f-8a8f-67510f80151a	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	0e089a44-0cee-4804-8f6f-8508508ddb5c	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	189b8ac6-e346-454f-b501-7645590ca4f8	2025-10-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Cold and Cough 4 Kids	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL	Hyland's Inc.	e06599ca-fc94-4b2c-829e-f3d4ec866ed6	2025-10-29	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Cardinal Health 107, LLC	97007188-43fe-416c-a87b-6ccc4d9ae2ec	2025-10-29	Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	ICU Medical Inc.	1c0bbcb7-5ed6-4ee7-b297-080d3359474e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	05f326e6-10e4-4ceb-8a23-f53c592f00b8	2025-10-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Corporation	6acc9f96-7088-45a7-b48f-1a861e3467ab	2025-10-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE	Baxter Healthcare Company	dad7735c-709b-40ea-ab7a-15577e24a966	2025-10-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
WALMART SALINE	SALINE NASAL (SODIUM CHLORIDE)	WALMART STORES INC	06906744-49a5-4bab-8539-af2d235df9e8	2025-10-28	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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