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 18 of 56 · 1,116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	beda35c3-9a8b-47ad-e053-2995a90a7b1b	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
Easy Care First Aid Eyewash	WATER	Tender Corporation	a070aac8-e6d2-ef10-e053-2a95a90aa5b1	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	e07a064b-f680-405c-bbcd-24fac430951e	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
ULINE Eyewash	EYEWASH	Niagara Pharmaceuticals Inc.	2d7f22d2-320b-6af1-e063-6294a90addc6	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
Pur-Wash	EYEWASH	Niagara Pharmaceuticals, Inc.	0d43b1c1-2699-37f1-e054-00144ff88e88	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	777e1559-786f-8d54-e053-2991aa0aa98d	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	7289103a-5cbf-42f4-8848-e827149a43ca	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
Natural Eyes Floaters Relief	CHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEA	TRP Company	445dc831-195e-4b25-e063-6294a90a6efd	2025-11-24	Warnings	Exact identifier unii: 451W47IQ8X
Eyewash Additive Concentrate	WATER AND PROPYLENE GLYCOL	Haws Corporation	dd168403-398c-41ff-b1df-d93e4ff39de3	2025-11-20	Warnings	Exact identifier unii: 059QF0KO0R
Vital Female Sexual Energy	AGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALIS	Liddell Laboratories, Inc.	1ca43c82-62b0-4191-81a4-27f7f94109dd	2025-11-20	Warnings	Exact identifier unii: 451W47IQ8X unii: 94ZLA3W45F
Sodium Chloride	SODIUM CHLORIDE	Walgreen Company	d112a344-33cc-41d3-bae6-492631ebdba7	2025-11-19	Warnings	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ce0c8c6f-734a-400f-9b60-a3b1e263f25f	2025-11-18	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Fresenius Kabi USA, LLC	fd823bef-c14c-4708-a18a-8aaa8470412f	2025-11-18	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE TABLETS	Kesin Pharma Corporation	2f107592-10c5-ef3b-e063-6394a90a7c0a	2025-11-17	Warnings	Exact identifier unii: 451W47IQ8X
ALUMIZEN	GARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.	Natural Creations, Inc.	4760ab09-1141-4944-b840-804ae6d86d2d	2025-11-13	Warnings	Exact identifier unii: 451W47IQ8X
BLISTER HP	JUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG.	Natural Creations, Inc.	e76f05e7-6d7b-4d2e-ba26-bf776bf0e657	2025-11-13	Warnings	Exact identifier unii: 451W47IQ8X
Anxiety HP	ARSENIC TRIOXIDE, CALCIUM CARBONATE, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA	Natural Creations, Inc.	13d92246-c20e-47a8-b88f-22da876fc545	2025-11-13	Warnings	Exact identifier unii: 451W47IQ8X
ANXIETY II HP	ACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF	Natural Creations, Inc.	02fa45a5-08e1-41ad-acd4-0f85db07e89e	2025-11-13	Warnings	Exact identifier unii: 451W47IQ8X
Eyesaline Eyewash Concentrate	PURIFIED WATER	Honeywell Safety Products USA, Inc.	3765c251-eb14-d60f-e063-6294a90a6a4d	2025-11-12	Warnings	Exact identifier unii: 059QF0KO0R
Eyesaline Emergency Eyewash	PURIFIED WATER	Honeywell Safety Products USA, Inc.	37f244fd-c02f-e66a-e063-6394a90aed81	2025-11-12	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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