Losartan potassium Tablets, 100 mg

Product NDC: 43353-299
11-digit product format: 433530299
Labeler code: 43353
Product ID: 43353-299_ba851086-d209-45ed-8d1e-bbf02f89e650
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: losartan potassium
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA201170
Marketing category: ANDA
Marketing start: 2012-09-18
Marketing end: 0000-00-00
Substance: LOSARTAN POTASSIUM
Active strength: 100 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
43353-299-60	2020-01-31	C162847	48780-1	9d75b9d0-8d8e-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 USP, for oral use Rx Only Initial U.S. Approval: 1995

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-299-60	Losartan potassium Tablets, 100 mg	90 in 1 BOTTLE	TABLET	90		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-299-60	EA - Each	43353-299	98ae9bcf-dd6b-4cdb-9ebb-d695f50dbaae	1	2017-11-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-299	LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 1 package rows	20171021_733e4f80-cb7c-498d-ace0-28cade2e5530.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
979480	losartan potassium 100 MG Oral Tablet	PSN	733e4f80-cb7c-498d-ace0-28cade2e5530	2
979480	losartan potassium 100 MG Oral Tablet	SCD	733e4f80-cb7c-498d-ace0-28cade2e5530	2
979480	Losartan K+ 100 MG Oral Tablet	SY	733e4f80-cb7c-498d-ace0-28cade2e5530	2
979480	Losartan Pot 100 MG Oral Tablet	SY	733e4f80-cb7c-498d-ace0-28cade2e5530	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-299-60	43353029960	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan potassium Tablets, 100 mg	Aphena Pharma Solutions - Tennessee, LLC	2017-10-18	HUMAN PRESCRIPTION DRUG LABEL	2