FDA.reportPublic FDA data

Losartan Potassium

Product NDC
11788-100
11-digit product format
117880100
Labeler code
11788
Product ID
11788-100_0768a3af-f3b0-406b-bedb-c4c4bf11d1d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA090544
Marketing category
ANDA
Marketing start
2025-12-15
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM25 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11788-100-10Losartan Potassium1000 in 1 BOTTLETABLET10001
11788-100-30Losartan Potassium30 in 1 BOTTLETABLET301
11788-100-90Losartan Potassium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-100-10EA - Each11788-100a564b385-fc1e-4158-b8b7-9b27afbdf8b512026-01-08
11788-100-30EA - Each11788-1005f4bcc52-f1b9-46ac-9810-fecfadb24a8e12026-01-08
11788-100-90EA - Each11788-100a1b669ef-571a-4d3c-8fd5-a0a7fe9e5fe812026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN1ae817aa-5221-4387-a457-3067851407411
979485losartan potassium 25 MG Oral TabletPSN1ae817aa-5221-4387-a457-3067851407411
979492losartan potassium 50 MG Oral TabletPSN1ae817aa-5221-4387-a457-3067851407411
979480losartan potassium 100 MG Oral TabletSCD1ae817aa-5221-4387-a457-3067851407411
979485losartan potassium 25 MG Oral TabletSCD1ae817aa-5221-4387-a457-3067851407411
979492losartan potassium 50 MG Oral TabletSCD1ae817aa-5221-4387-a457-3067851407411
979480Losartan K+ 100 MG Oral TabletSY1ae817aa-5221-4387-a457-3067851407411
979485Losartan K+ 25 MG Oral TabletSY1ae817aa-5221-4387-a457-3067851407411
979492Losartan K+ 50 MG Oral TabletSY1ae817aa-5221-4387-a457-3067851407411
979480Losartan Pot 100 MG Oral TabletSY1ae817aa-5221-4387-a457-3067851407411
979485Losartan Pot 25 MG Oral TabletSY1ae817aa-5221-4387-a457-3067851407411
979492Losartan Pot 50 MG Oral TabletSY1ae817aa-5221-4387-a457-3067851407411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-100-10117880100101000 TABLET in 1 BOTTLE (11788-100-10) 1000 tablet2025-12-15NoNoHistorical
11788-100-301178801003030 TABLET in 1 BOTTLE (11788-100-30) 30 tablet2025-12-15NoNoHistorical
11788-100-901178801009090 TABLET in 1 BOTTLE (11788-100-90) 90 tablet2025-12-15NoNoHistorical