bumetanide

Product NDC: 16714-831
11-digit product format: 167140831
Labeler code: 16714
Product ID: 16714-831_3f2c7e4c-9e79-4335-a7da-5beb2dde5543
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bumetanide
Dosage form: TABLET
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA202900
Marketing category: ANDA
Marketing start: 2018-06-25
Marketing end: 0000-00-00
Substance: BUMETANIDE
Active strength: 1 mg/1
Pharmacologic classes: Loop Diuretic [EPC],Increased Diuresis at Loop of Henle [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d3f2f0a-cce7-32fe-77bf-6ee61839e736	Product name	9	20260113
601d9750-f415-d9d9-619c-0a87b4d3f237	Product name	3	20250331
1d3f2f0a-cce7-32fe-77bf-6ee61839e736	Product name	2	20171211

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-831-01	EA - Each	16714-831	03cd6ae3-b580-4696-9882-d9a73bbbedde	1	2018-12-13

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0Y2S3XUQ5H	BUMETANIDE	28395-03-1	BUMETANIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197417	bumetanide 0.5 MG Oral Tablet	PSN	7412c5f1-6508-4e5c-a3c1-84ed54dc688c	1
197417	bumetanide 0.5 MG Oral Tablet	SCD	7412c5f1-6508-4e5c-a3c1-84ed54dc688c	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-831-01	16714083101	100 TABLET in 1 BOTTLE (16714-831-01)	100 tablet	2018-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bumetanide Tablets, USP Rx only	A-S Medication Solutions	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	1