FDA.reportPublic FDA data

Losartan Potassium

Product NDC
63187-708
11-digit product format
631870708
Labeler code
63187
Product ID
63187-708_e7f9bccb-bb82-49fd-b59b-92670ee46f9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203835
Marketing category
ANDA
Marketing start
2015-08-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ST302B24A
Rxcui979480

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
63187-708-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED304
63187-708-60Losartan Potassium60 in 1 BOTTLETABLET, FILM COATED604
63187-708-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-708-30EA - Each63187-708a2f6d754-19f5-4714-8ef3-0341cc887cf712021-02-05
63187-708-90EA - Each63187-7084912c9fa-67a1-4e8a-963d-437183ad641f12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-708LOSARTAN POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220816_5b1f6677-9473-467f-9fb6-efadbd8828e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN5b1f6677-9473-467f-9fb6-efadbd8828e84
979480losartan potassium 100 MG Oral TabletSCD5b1f6677-9473-467f-9fb6-efadbd8828e84
979480Losartan K+ 100 MG Oral TabletSY5b1f6677-9473-467f-9fb6-efadbd8828e84
979480Losartan Pot 100 MG Oral TabletSY5b1f6677-9473-467f-9fb6-efadbd8828e84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-708-306318707083030 TABLET, FILM COATED in 1 BOTTLE (63187-708-30) 2016-06-010000-00-00NoNoCurrent
63187-708-606318707086060 TABLET, FILM COATED in 1 BOTTLE (63187-708-60) 2016-06-010000-00-00NoNoCurrent
63187-708-906318707089090 TABLET, FILM COATED in 1 BOTTLE (63187-708-90) 2016-06-010000-00-00NoNoCurrent