CardioGen-82

Product NDC: 0270-0091
11-digit product format: 002700091
Labeler code: 0270
Product ID: 0270-0091_990b8a5b-d1f5-2119-1e01-cdccdcb607ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rubidium Chloride RB-82
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Bracco Diagnostics Inc
Application: NDA019414
Marketing category: NDA
Marketing start: 1989-12-30
Substance: RUBIDIUM CHLORIDE RB-82
Active strength: 150 mCi/1
Pharmacologic classes: Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
RUBIDIUM CHLORIDE RB-82	150 mCi/1

Field, Values table
Field	Values
Unii	F0Z746KRKQ

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c3883cc8-cbf6-4d6a-9dea-01b391ccdf30	Product name	1	20230706
f5f3b089-ebd1-4c99-a3f1-54aaf17b6c75	Product name	1	20210513

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0270-0091-01	2022-08-29	C162847	48780-1	e4f33bdf-9fa4-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82. CARDIOGEN-82 ® (rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous use Initial U.S. Approval: 1989
0270-0091-01	2022-07-29	C162847	48780-1	e4f33bdf-9fa4-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use CARDIOGEN-82 safely and effectively. See full prescribing information for CARDIOGEN-82. CARDIOGEN-82 ® (rubidium Rb 82 generator) to produce rubidium chloride Rb 82 injection, for intravenous use Initial U.S. Approval: 1989

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0270-0091-01	CardioGen-82	1 in 1 PACKAGE	INJECTION, SOLUTION	1		19

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0270-0091-01	EA - Each	0270-0091	1e6ec46d-dfe7-422f-a1b6-2b97bedaf74e	1	2024-03-12

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
RUBIDIUM CHLORIDE RB-82	ACTIVE INGREDIENT	F0Z746KRKQ	CARDIOGEN-82 (RUBIDIUM CHLORIDE RB-82) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	4
RUBIDIUM CATION RB-82	ACTIVE MOIETY	550Z839889	CARDIOGEN-82 (RUBIDIUM CHLORIDE RB-82) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0270-0091	CARDIOGEN-82 (RUBIDIUM CHLORIDE RB-82) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	18	Current NDC, Legacy NDC, 1 package rows	20250129_ee95aa18-9f2f-40eb-9b4c-583bea6f36bf.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F0Z746KRKQ	RUBIDIUM CHLORIDE RB-82	132486-03-4	RUBIDIUM CHLORIDE RB-82

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0270-0091-01	00270009101	1 INJECTION, SOLUTION in 1 PACKAGE (0270-0091-01)	1989-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CardioGen-82	Bracco Diagnostics Inc \| GE HEALTHCARE INC. \| BWXT ITG Canada, Inc.	2025-08-13	HUMAN PRESCRIPTION DRUG LABEL	19