FDA.reportPublic FDA data

Losartan Potassium

Product NDC
31722-702
11-digit product format
317220702
Labeler code
31722
Product ID
31722-702_40b34aeb-20b5-4200-e063-6394a90a96e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
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, 979485, 979492

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
31722-702-05Losartan Potassium500 in 1 BOTTLETABLET, FILM COATED5006
31722-702-10Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED10006
31722-702-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED306
31722-702-60Losartan Potassium60 in 1 BOTTLETABLET, FILM COATED606
31722-702-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-702-10EA - Each31722-7027f6a5d78-bfcd-488d-93bc-fb04d266102112015-12-02
31722-702-30EA - Each31722-7020d31c0d4-a5be-421f-ac19-be9f7ce44a3112016-01-13
31722-702-90EA - Each31722-702972e14c3-0fc1-4577-ad19-287ce3f65d5412015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZLOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-702LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 5 package rows20250110_cafd54e8-42a8-474c-8ea8-49ec74c2b0d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN9b3ddaa2-a835-736a-e053-2995a90aff0813
979480losartan potassium 100 MG Oral TabletSCD9b3ddaa2-a835-736a-e053-2995a90aff0813
979480Losartan K+ 100 MG Oral TabletSY9b3ddaa2-a835-736a-e053-2995a90aff0813
979480Losartan Pot 100 MG Oral TabletSY9b3ddaa2-a835-736a-e053-2995a90aff0813
979480losartan potassium 100 MG Oral TabletPSN27e783ce-3353-448a-b0a3-c954dfd2e4c711
979480losartan potassium 100 MG Oral TabletSCD27e783ce-3353-448a-b0a3-c954dfd2e4c711
979480Losartan K+ 100 MG Oral TabletSY27e783ce-3353-448a-b0a3-c954dfd2e4c711
979480Losartan Pot 100 MG Oral TabletSY27e783ce-3353-448a-b0a3-c954dfd2e4c711
979480losartan potassium 100 MG Oral TabletPSNf68fd1a2-1cbf-47c8-b8c4-df49cf17540e7
979480losartan potassium 100 MG Oral TabletSCDf68fd1a2-1cbf-47c8-b8c4-df49cf17540e7
979480Losartan K+ 100 MG Oral TabletSYf68fd1a2-1cbf-47c8-b8c4-df49cf17540e7
979480Losartan Pot 100 MG Oral TabletSYf68fd1a2-1cbf-47c8-b8c4-df49cf17540e7
979480losartan potassium 100 MG Oral TabletPSN0f3a6984-e601-4a74-9910-49ee5e352d6b6
979480losartan potassium 100 MG Oral TabletPSNcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979485losartan potassium 25 MG Oral TabletPSN0f3a6984-e601-4a74-9910-49ee5e352d6b6
979485losartan potassium 25 MG Oral TabletPSNcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979492losartan potassium 50 MG Oral TabletPSN0f3a6984-e601-4a74-9910-49ee5e352d6b6
979492losartan potassium 50 MG Oral TabletPSNcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979480losartan potassium 100 MG Oral TabletSCD0f3a6984-e601-4a74-9910-49ee5e352d6b6
979480losartan potassium 100 MG Oral TabletSCDcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979485losartan potassium 25 MG Oral TabletSCD0f3a6984-e601-4a74-9910-49ee5e352d6b6
979485losartan potassium 25 MG Oral TabletSCDcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979492losartan potassium 50 MG Oral TabletSCD0f3a6984-e601-4a74-9910-49ee5e352d6b6
979492losartan potassium 50 MG Oral TabletSCDcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979480Losartan K+ 100 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979480Losartan K+ 100 MG Oral TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979485Losartan K+ 25 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979485Losartan K+ 25 MG Oral TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979492Losartan K+ 50 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979492Losartan K+ 50 MG Oral TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979480Losartan Pot 100 MG Oral TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979480Losartan Pot 100 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979485Losartan Pot 25 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979485Losartan Pot 25 MG Oral TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979492Losartan Pot 50 MG Oral TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979492Losartan Pot 50 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979480losartan potassium 100 MG Oral TabletPSNe9aa536e-0747-45bf-e053-2995a90ae7d64
979480losartan potassium 100 MG Oral TabletPSNd9df33c8-4ea7-5d1c-e053-2a95a90aecf74
979480losartan potassium 100 MG Oral TabletPSN5b1f6677-9473-467f-9fb6-efadbd8828e84
979480losartan potassium 100 MG Oral TabletSCDe9aa536e-0747-45bf-e053-2995a90ae7d64
979480losartan potassium 100 MG Oral TabletSCDd9df33c8-4ea7-5d1c-e053-2a95a90aecf74
979480losartan potassium 100 MG Oral TabletSCD5b1f6677-9473-467f-9fb6-efadbd8828e84
979480Losartan K+ 100 MG Oral TabletSYe9aa536e-0747-45bf-e053-2995a90ae7d64
979480Losartan K+ 100 MG Oral TabletSYd9df33c8-4ea7-5d1c-e053-2a95a90aecf74
979480Losartan K+ 100 MG Oral TabletSY5b1f6677-9473-467f-9fb6-efadbd8828e84
979480Losartan Pot 100 MG Oral TabletSYe9aa536e-0747-45bf-e053-2995a90ae7d64
979480Losartan Pot 100 MG Oral TabletSYd9df33c8-4ea7-5d1c-e053-2a95a90aecf74
979480Losartan Pot 100 MG Oral TabletSY5b1f6677-9473-467f-9fb6-efadbd8828e84
979480losartan potassium 100 MG Oral TabletPSN9f1c20aa-2028-412d-e053-2995a90a13683
979480losartan potassium 100 MG Oral TabletPSN70570c01-75fd-4d15-8856-a99ff29b7d893
979480losartan potassium 100 MG Oral TabletPSNaa58c629-f7d9-a6e0-e053-2995a90ac1883
979480losartan potassium 100 MG Oral TabletPSNba76eb91-bea6-4e37-e053-2a95a90a065a3
979480losartan potassium 100 MG Oral TabletSCD70570c01-75fd-4d15-8856-a99ff29b7d893
979480losartan potassium 100 MG Oral TabletSCD9f1c20aa-2028-412d-e053-2995a90a13683
979480losartan potassium 100 MG Oral TabletSCDaa58c629-f7d9-a6e0-e053-2995a90ac1883
979480losartan potassium 100 MG Oral TabletSCDba76eb91-bea6-4e37-e053-2a95a90a065a3
979480Losartan K+ 100 MG Oral TabletSYba76eb91-bea6-4e37-e053-2a95a90a065a3
979480Losartan K+ 100 MG Oral TabletSY9f1c20aa-2028-412d-e053-2995a90a13683
979480Losartan K+ 100 MG Oral TabletSYaa58c629-f7d9-a6e0-e053-2995a90ac1883
979480Losartan K+ 100 MG Oral TabletSY70570c01-75fd-4d15-8856-a99ff29b7d893
979480Losartan Pot 100 MG Oral TabletSYba76eb91-bea6-4e37-e053-2a95a90a065a3
979480Losartan Pot 100 MG Oral TabletSYaa58c629-f7d9-a6e0-e053-2995a90ac1883
979480Losartan Pot 100 MG Oral TabletSY9f1c20aa-2028-412d-e053-2995a90a13683
979480Losartan Pot 100 MG Oral TabletSY70570c01-75fd-4d15-8856-a99ff29b7d893
979480losartan potassium 100 MG Oral TabletPSN1e1d8fc0-4646-d780-e063-6294a90a9c191
979480losartan potassium 100 MG Oral TabletSCD1e1d8fc0-4646-d780-e063-6294a90a9c191
979480Losartan K+ 100 MG Oral TabletSY1e1d8fc0-4646-d780-e063-6294a90a9c191
979480Losartan Pot 100 MG Oral TabletSY1e1d8fc0-4646-d780-e063-6294a90a9c191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-702-0531722070205500 TABLET, FILM COATED in 1 BOTTLE (31722-702-05) 2015-08-190000-00-00NoNoCurrent
31722-702-10317220702101000 TABLET, FILM COATED in 1 BOTTLE (31722-702-10) 2015-08-190000-00-00NoNoCurrent
31722-702-303172207023030 TABLET, FILM COATED in 1 BOTTLE (31722-702-30) 2015-08-190000-00-00NoNoCurrent
31722-702-603172207026060 TABLET, FILM COATED in 1 BOTTLE (31722-702-60) 2015-08-190000-00-00NoNoCurrent
31722-702-903172207029090 TABLET, FILM COATED in 1 BOTTLE (31722-702-90) 2015-08-190000-00-00NoNoCurrent