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 21 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Saline	NASAL	PUBLIX SUPER MARKETS, INC	19841567-9511-43d6-ba4e-d1e1bd3481a4	2025-10-28	Warnings	Exact identifier unii: 451W47IQ8X
Bacteriostatic Water	WATER	Henry Schein, Inc.	a833502e-a622-4e81-8c58-cef6ccb6c4c9	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Anti Nausea	DEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACID	RUGBY LABORATORIES	8506b4ab-a19e-4b0d-aa98-143bf75a1171	2025-10-25	Warnings	Exact identifier unii: IY9XDZ35W2
Jacksons Cell Salts KALI MUR 6X 5	KALI MURIATICUM	Zettl Health Inc.	41ed34d0-94c3-ce79-e063-6294a90a08cb	2025-10-24	Warnings	Exact identifier unii: 451W47IQ8X
NORMOSOL-M AND DEXTROSE	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE	ICU Medical Inc.	aba60c84-94d9-46d0-bdbb-25e0c4e8cc41	2025-10-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
miranda castros HEALING FOR INSECT BITES AND STINGS	CALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS	MIRANDA CASTRO'S SHOP, LLC	1f99d32e-2394-411a-e063-6294a90ac454	2025-10-23	Warnings	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	ICU Medical Inc.	b96eb740-749a-4d3a-ae63-b8e3947cad30	2025-10-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Becton Dickinson and Company	cab03cda-4660-4020-a3be-bf86242ff664	2025-10-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Method Pharmaceuticals	ce84727a-3677-4bf0-e053-2995a90a3ec8	2025-10-21	Warnings	Exact identifier unii: 451W47IQ8X
Sugar Cravings	CINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNER	Dr. Donna Restivo DC	401873ba-ae1b-4506-a2e8-c6c0e5ff27f5	2025-10-21	Warnings	Exact identifier unii: IY9XDZ35W2
Aminosyn-PF	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE	ICU Medical Inc.	2d212e10-7e08-4aeb-b63f-dcc927897769	2025-10-17	Warnings, Adverse reactions	Exact identifier unii: 4QD397987E unii: 94ZLA3W45F
Walgreens	SODIUM CHLORIDE	Walgreen Company	21dfc2cf-65ae-c3fb-e063-6294a90a0a94	2025-10-17		Exact identifier unii: 451W47IQ8X
Homeopathic Tea Tree Oil Lice	EUCALYPTUS GLOBULUS, NATRUM MURIATICUM	DOLGENCORP, LLC	0a0c2db2-7eeb-909c-e063-6394a90a7a90	2025-10-15	Warnings	Exact identifier unii: 451W47IQ8X
Anti Nausea	DEXTROSE(GLUCOSE),LEVULOSE(FRUCTOSE),PHOSPHORIC ACID	Cardinal Health	b2f0e93f-a2e9-4970-bfb8-de30a6247813	2025-10-14	Warnings	Exact identifier unii: IY9XDZ35W2
Saline Ampoules	SODIUM CHLORIDE 0.9%	Trifecta Pharmaceuticals USA, LLC.	ee18ef7c-bb5d-30ec-e053-2a95a90a964e	2025-10-13	Warnings	Exact identifier unii: 451W47IQ8X
Aminosyn-PF	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE	ICU Medical Inc.	46e74ce4-cd7e-437f-bf54-ca9b98eb2663	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4QD397987E unii: 94ZLA3W45F
EQUATE SALINE PACKETS	NASAL CLEANING SALT	WALMART INC	9e905ecb-d4d5-514a-e053-2a95a90adfbb	2025-10-08	Warnings	Exact identifier unii: 451W47IQ8X
EQUATE NETI POT SINUS WASH	NASAL WASH	WALMART INC	9e90c1c1-4dcd-106e-e053-2995a90afd15	2025-10-08	Warnings	Exact identifier unii: 451W47IQ8X
GURUNANDA NASAL SALINE	NASAL WASH	GURUNANDA LLC	2b4d78ae-b587-6dfe-e063-6394a90a8876	2025-10-08	Warnings	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ca3355f2-2cf0-4f58-bed5-0c4c0a7d3511	2025-10-08	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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