Losartan Potassium

Product NDC
82009-043
11-digit product format
820090043
Labeler code
82009
Product ID
82009-043_55d92567-c635-4877-91cb-dd142c71c4fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA078243
Marketing category
ANDA
Marketing start
2022-09-20
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
Rxcui979480, 979485, 979492

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82009-043-10Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-043-10EA - Each82009-043a8f35589-fa40-4664-8f50-e10e257607e012022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-043LOSARTAN POTASSIUM TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, Legacy NDC, 1 package rows20230930_1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979485losartan potassium 25 MG Oral TabletPSN1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979492losartan potassium 50 MG Oral TabletPSN1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979480losartan potassium 100 MG Oral TabletSCD1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979485losartan potassium 25 MG Oral TabletSCD1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979492losartan potassium 50 MG Oral TabletSCD1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979480Losartan K+ 100 MG Oral TabletSY1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979485Losartan K+ 25 MG Oral TabletSY1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979492Losartan K+ 50 MG Oral TabletSY1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979480Losartan Pot 100 MG Oral TabletSY1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979485Losartan Pot 25 MG Oral TabletSY1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7
979492Losartan Pot 50 MG Oral TabletSY1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82009-043-10820090043101000 TABLET, FILM COATED in 1 BOTTLE (82009-043-10) 2022-09-200000-00-00NoNoCurrent