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 11 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0.9%saline	SODIUM CHLORIDE	Huizhou Jinsheng Medical Technology Co., Ltd	49e7b329-e4e5-6991-e063-6294a90ac817	2026-02-03	Warnings	Exact identifier unii: 451W47IQ8X
Adrenal Support	ADRENALINUM, BERBERIS VULGARIS, ARGENTUM NITRICUM, NATRUM MURIATICUM, VANADIUM METALLICUM, OLEUM MORRHUAE, PETROLEUM	NaturalCare	cee52757-a86e-4251-b65f-954ac85f4e7e	2026-01-30	Warnings	Exact identifier unii: 451W47IQ8X
Vital Female Sexual Energy	AGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERRULATA, SEPIA, THUJA OCCIDENTALIS	Liddell Laboratories, Inc.	7b15d6fa-eb04-41d2-8a01-6e7408ccf4d3	2026-01-30	Warnings	Exact identifier unii: 451W47IQ8X unii: 94ZLA3W45F
Additive Formula 3	DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE	Terumo BCT, Ltd	9a5247a1-cc05-442d-b2d0-950f887f03c2	2026-01-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
CVS ULTRA FINE MOISTURIZING SALINE MIST	NASAL MIST	CVS	44821c47-63f9-5d0a-e063-6394a90a555d	2026-01-29	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID MONOHYDRATE	Atlantic Biologicals Corp.	42d837ae-2578-46df-92d2-24774964aaad	2026-01-28	Adverse reactions	Exact identifier unii: 1Q73Q2JULR
Sodium Chloride	SODIUM CHLORIDE	Nephron Pharmaceuticals Corporation	a4edf2d5-a9ff-30d4-e053-2995a90a5650	2026-01-26	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
INSULIN DILUTING MEDIUM FOR Kirsty	WATER	Biocon Biologics Inc.	3db1d482-7e1f-aec6-79ef-3f305b4d8277	2026-01-20	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	ProPharma Distribution	48d73434-e65b-dc98-e063-6294a90affa2	2026-01-20	Adverse reactions	Exact identifier unii: 451W47IQ8X
Equate Comfort Flow Sinus wash	SINUS WASH	WALMART INC	9e911eef-ca99-9902-e053-2a95a90aab0e	2026-01-19	Warnings	Exact identifier unii: 451W47IQ8X
EQUATE PREMIUM SALINE	SODIUM CHLORIDE 0.65%	Walmart Stores, Inc.	1e17f022-f513-140d-e063-6394a90a379e	2026-01-19	Warnings	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	d98bf9f7-30ec-4927-a577-cabad192cb18	2026-01-19	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
WALGREEN CHILDREN ANTI NAUSEA	DEXTROSE, LEVULOSE, PHOSPHORIC ACID	WALGREENS CO.	1c5659ec-100f-49c6-8f2c-58c14fc7dfed	2026-01-16	Warnings	Exact identifier unii: IY9XDZ35W2
Sodium Chloride Hypertonicity	SODIUM CHLORIDE	CVS Pharmacy	9245d842-7f78-42d8-83ba-8eb9ec8dbc0d	2026-01-15	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride Hypertonicity	SODIUM CHLORIDE	CVS PHARMACY	d5cc6cd1-ddf8-4f5b-a021-204cdda0db94	2026-01-15	Warnings	Exact identifier unii: 451W47IQ8X
Walgreens Sterile Soothing Eye Wash	PURIFIED WATER	Walgreens	a62e3294-abd6-48dc-81b1-62a809bdc968	2026-01-14	Warnings	Exact identifier unii: 059QF0KO0R
Constipation Relief	ALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDE	Homeocare Laboratories	62374240-cd14-44e2-9405-5f8996faf047	2026-01-12	Warnings	Exact identifier unii: 451W47IQ8X
Luffa	LUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTA	Marco Pharma International LLC.	7dbb79de-c3f5-4245-884a-a6bd29bb861c	2026-01-12	Warnings	Exact identifier unii: 451W47IQ8X
Hepaticol Drops 5008	HEPATICOL DROPS	Professional Complementary Health Formulas	79ee9e37-7853-4560-a87d-cdaefb603bbb	2026-01-08	Warnings	Exact identifier unii: 451W47IQ8X
Weight Management Formula 7534	WEIGHT MANAGEMENT FORMULA	Professional Complementary Health Formulas	f0406b63-7b97-4b2c-b976-75e8890818c6	2026-01-08	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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