Losartan Potassium and Hydrochlorothiazide

Product NDC: 50090-5475
11-digit product format: 500905475
Labeler code: 50090
Product ID: 50090-5475_aeb3f4d2-caa7-4d38-b172-37d494c45a88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium and Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077157
Marketing category: ANDA
Marketing start: 2010-04-06
Marketing end: 0000-00-00
Substance: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength: 50 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3ST302B24A	LOSARTAN POTASSIUM	124750-99-8	LOSARTAN POTASSIUM
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979468	losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	0d431d5d-6bcc-4caf-be22-db90a060e9fa	1
979468	hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral Tablet	SCD	0d431d5d-6bcc-4caf-be22-db90a060e9fa	1
979468	HCTZ 12.5 MG / Losartan K+ 50 MG Oral Tablet	SY	0d431d5d-6bcc-4caf-be22-db90a060e9fa	1
979468	HCTZ 12.5 MG / Losartan Pot 50 MG Oral Tablet	SY	0d431d5d-6bcc-4caf-be22-db90a060e9fa	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5475-0	50090547500	90 TABLET, FILM COATED in 1 BOTTLE (50090-5475-0)	2021-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium and Hydrochlorothiazide	A-S Medication Solutions	2021-03-09	HUMAN PRESCRIPTION DRUG LABEL	1