FDA.reportPublic FDA data

Losartan Potassium

Product NDC
50090-4489
11-digit product format
500904489
Labeler code
50090
Product ID
50090-4489_9edec7d5-8354-46fb-837d-393ce6b7f2d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203835
Marketing category
ANDA
Marketing start
2015-08-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui979492

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4489-0Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED3011
50090-4489-1Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED9011
50090-4489-2Losartan Potassium100 in 1 BOTTLETABLET, FILM COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4489-0EA - Each50090-4489cc2686a8-ba7e-4576-8382-c3f243c6317112022-07-06
50090-4489-1EA - Each50090-4489f7236c55-771d-4f5f-bd4a-c38d1dcf762812023-09-05
50090-4489-2EA - Each50090-44892e976bfa-52f5-4b4b-a8a7-1dcb8887ccf012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4489LOSARTAN POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20230814_f29cc61a-afba-4ecb-8043-5f103872f1ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSNf29cc61a-afba-4ecb-8043-5f103872f1ae11
979492losartan potassium 50 MG Oral TabletSCDf29cc61a-afba-4ecb-8043-5f103872f1ae11
979492Losartan K+ 50 MG Oral TabletSYf29cc61a-afba-4ecb-8043-5f103872f1ae11
979492Losartan Pot 50 MG Oral TabletSYf29cc61a-afba-4ecb-8043-5f103872f1ae11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4489-05009044890030 TABLET, FILM COATED in 1 BOTTLE (50090-4489-0) 2019-08-290000-00-00NoNoCurrent
50090-4489-15009044890190 TABLET, FILM COATED in 1 BOTTLE (50090-4489-1) 2019-08-290000-00-00NoNoCurrent
50090-4489-250090448902100 TABLET, FILM COATED in 1 BOTTLE (50090-4489-2) 2023-08-09NoNoHistorical