LOSARTAN POTASSIUM

Product NDC
72189-082
11-digit product format
721890082
Labeler code
72189
Product ID
72189-082_2be871d4-0d2d-9f90-e063-6294a90ad6d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOSARTAN POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078243
Marketing category
ANDA
Marketing start
2020-06-16
Substance
LOSARTAN POTASSIUM
Active strength
25 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

openFDA Listing Details

Product ID
72189-082_2be871d4-0d2d-9f90-e063-6294a90ad6d2
SPL ID
2be871d4-0d2d-9f90-e063-6294a90ad6d2
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
LOSARTAN POTASSIUM
Generic name
LOSARTAN POTASSIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Marketing start
2020-06-16
Marketing category
ANDA
Application number
ANDA078243
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
LOSARTAN POTASSIUM25 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii3ST302B24A
Rxcui979485
Spl Set Ida58c56b2-e05c-6697-e053-2a95a90ad466
Manufacturer NameDIRECT RX

openFDA Package Details

Package NDCDescriptionMarketing startSample
72189-082-3030 TABLET, FILM COATED in 1 BOTTLE (72189-082-30)2020-06-16No
72189-082-9090 TABLET, FILM COATED in 1 BOTTLE (72189-082-90)2020-06-16No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
3ST302B24ALOSARTAN POTASSIUM124750-99-8LOSARTAN POTASSIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-082-307218900823030 TABLET, FILM COATED in 1 BOTTLE (72189-082-30) 2020-06-16NoNoHistorical
72189-082-907218900829090 TABLET, FILM COATED in 1 BOTTLE (72189-082-90) 2020-06-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LOSARTAN POTASSIUMDIRECT RX2025-01-17HUMAN PRESCRIPTION DRUG LABEL5