FDA.reportPublic FDA data

Losartan Potassium

Product NDC
43063-854
11-digit product format
430630854
Labeler code
43063
Product ID
43063-854_525abf19-736b-8fd8-e063-6294a90a30b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
43063-854-60Losartan Potassium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6016
43063-854-90Losartan Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-854-60EA - Each43063-854b1e2e33e-84be-4f45-a359-82b3b441a94f12019-02-13
43063-854-90EA - Each43063-854f8dc9ff3-ca56-4f5a-bf34-414d5debcf1212018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-854LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 2 package rows20250315_abb56236-f2fe-45b5-93ac-35fd661f8992.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSNabb56236-f2fe-45b5-93ac-35fd661f899216
979492losartan potassium 50 MG Oral TabletSCDabb56236-f2fe-45b5-93ac-35fd661f899216
979492Losartan K+ 50 MG Oral TabletSYabb56236-f2fe-45b5-93ac-35fd661f899216
979492Losartan Pot 50 MG Oral TabletSYabb56236-f2fe-45b5-93ac-35fd661f899216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-854-604306308546060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-854-60) 2019-01-140000-00-00NoNoCurrent
43063-854-904306308549090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-854-90) 2018-05-290000-00-00NoNoCurrent