Losartan Potassium

Product NDC: 53217-337
11-digit product format: 532170337
Labeler code: 53217
Product ID: 53217-337_5f975161-b6e6-4783-afc3-bd6c669cf12f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA091497
Marketing category: ANDA
Marketing start: 2017-11-10
Marketing end: 0000-00-00
Substance: LOSARTAN POTASSIUM
Active strength: 50 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0d341e63-aee5-498b-bf9a-b53a43963acf	Product name	1	20260105
de29c5c0-90ba-29da-d7ab-0500274708be	Product name	6	20241009
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-337-30	2020-01-31	C162847	48780-1	9d75b9d0-3637-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. see full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-337-30	Losartan Potassium	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-337	LOSARTAN POTASSIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180814_53eebb72-6733-42c3-b015-f5f91b7f4a24.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3ST302B24A	LOSARTAN POTASSIUM	124750-99-8	LOSARTAN POTASSIUM

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979492	losartan potassium 50 MG Oral Tablet	PSN	53eebb72-6733-42c3-b015-f5f91b7f4a24	1
979492	losartan potassium 50 MG Oral Tablet	SCD	53eebb72-6733-42c3-b015-f5f91b7f4a24	1
979492	Losartan K+ 50 MG Oral Tablet	SY	53eebb72-6733-42c3-b015-f5f91b7f4a24	1
979492	Losartan Pot 50 MG Oral Tablet	SY	53eebb72-6733-42c3-b015-f5f91b7f4a24	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-337-30	53217033730	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-14	HUMAN PRESCRIPTION DRUG LABEL	1