Indium 111 Oxyquinolone

Product NDC: 51808-126
11-digit product format: 518080126
Labeler code: 51808
Product ID: 51808-126_b16e5845-c429-4530-969b-a7cbabe43116
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indium 111 Oxyquinolone
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: AnazaoHealth Corporation
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2012-06-19
Marketing end: 0000-00-00
Substance: INDIUM IN-111 OXYQUINOLINE
Active strength: 2 mCi/mL
Pharmacologic classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bbd6bead-5f01-4935-a7c1-b17c43e7374c	Product name	1	20181004

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51808-126-01	2019-11-13	C162847	48780-1	97449f38-bcdb-f6ea-e053-dbdaa90aa703	Indium 111 Oxyquinolone (In-111 Oxine)

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51808-126-01	Indium 111 Oxyquinolone	1 mL in 1 VIAL	SOLUTION	1		1

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDIUM IN-111 OXYQUINOLINE	ACTIVE INGREDIENT	LGX9OL562T	INDIUM 111 OXYQUINOLONE SOLUTION [ANAZAOHEALTH CORPORATION]	1
INDIUM IN-111 OXYQUINOLINE	ACTIVE MOIETY	LGX9OL562T	INDIUM 111 OXYQUINOLONE SOLUTION [ANAZAOHEALTH CORPORATION]	1
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID	INACTIVE INGREDIENT	RWW266YE9I	INDIUM 111 OXYQUINOLONE SOLUTION [ANAZAOHEALTH CORPORATION]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	INDIUM 111 OXYQUINOLONE SOLUTION [ANAZAOHEALTH CORPORATION]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51808-126	INDIUM 111 OXYQUINOLONE SOLUTION [ANAZAOHEALTH CORPORATION]	1	Legacy NDC, 1 package rows	20120709_eadcaf93-c53e-41b6-aebb-7e7d57f5b303.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LGX9OL562T	INDIUM IN-111 OXYQUINOLINE	65389-08-4	INDIUM IN-111 OXYQUINOLINE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51808-126-01	51808012601	1 mL in 1 VIAL	1 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indium 111 Oxyquinolone (In-111 Oxine)	AnazaoHealth Corporation	2012-06-19	HUMAN PRESCRIPTION DRUG LABEL	1