FDA.reportPublic FDA data

Losartan Potassium

Product NDC
31722-700
11-digit product format
317220700
Labeler code
31722
Product ID
31722-700_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
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
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-700-05Losartan Potassium500 in 1 BOTTLETABLET, FILM COATED5006
31722-700-10Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED10006
31722-700-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED306
31722-700-60Losartan Potassium60 in 1 BOTTLETABLET, FILM COATED606
31722-700-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-700-05EA - Each31722-700df85a2cc-2e7b-4b8f-90f6-e38af69901e812015-12-02
31722-700-10EA - Each31722-700a4d0abb3-4450-4a1d-84bf-91b91b649b6a12015-12-02
31722-700-90EA - Each31722-70084fe9a7b-7e1c-47be-82e3-bfd267f82ed612015-12-02

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
31722-700LOSARTAN 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
979485losartan potassium 25 MG Oral TabletPSN1843ee4b-1afc-4992-993a-4b0e03e785fc14
979485losartan potassium 25 MG Oral TabletSCD1843ee4b-1afc-4992-993a-4b0e03e785fc14
979485Losartan K+ 25 MG Oral TabletSY1843ee4b-1afc-4992-993a-4b0e03e785fc14
979485Losartan Pot 25 MG Oral TabletSY1843ee4b-1afc-4992-993a-4b0e03e785fc14
979485losartan potassium 25 MG Oral TabletPSN54e902e6-d443-484a-bed1-e2669656b5139
979485losartan potassium 25 MG Oral TabletSCD54e902e6-d443-484a-bed1-e2669656b5139
979485Losartan K+ 25 MG Oral TabletSY54e902e6-d443-484a-bed1-e2669656b5139
979485Losartan Pot 25 MG Oral TabletSY54e902e6-d443-484a-bed1-e2669656b5139
979485losartan potassium 25 MG Oral TabletPSN45c01cc9-c7d1-4bb6-a105-354fc936ec637
979485losartan potassium 25 MG Oral TabletSCD45c01cc9-c7d1-4bb6-a105-354fc936ec637
979485Losartan K+ 25 MG Oral TabletSY45c01cc9-c7d1-4bb6-a105-354fc936ec637
979485Losartan Pot 25 MG Oral TabletSY45c01cc9-c7d1-4bb6-a105-354fc936ec637
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 TabletSCDcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979480losartan potassium 100 MG Oral TabletSCD0f3a6984-e601-4a74-9910-49ee5e352d6b6
979485losartan potassium 25 MG Oral TabletSCDcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979485losartan potassium 25 MG Oral TabletSCD0f3a6984-e601-4a74-9910-49ee5e352d6b6
979492losartan potassium 50 MG Oral TabletSCDcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979492losartan potassium 50 MG Oral TabletSCD0f3a6984-e601-4a74-9910-49ee5e352d6b6
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 TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979485Losartan Pot 25 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979492Losartan Pot 50 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979492Losartan Pot 50 MG Oral TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979485losartan potassium 25 MG Oral TabletPSNc80b36c2-fa22-e7a9-e053-2a95a90ae21e4
979485losartan potassium 25 MG Oral TabletPSN5abf6586-c2c7-4f4e-9f07-3c38582a33ad4
979485losartan potassium 25 MG Oral TabletSCDc80b36c2-fa22-e7a9-e053-2a95a90ae21e4
979485losartan potassium 25 MG Oral TabletSCD5abf6586-c2c7-4f4e-9f07-3c38582a33ad4
979485Losartan K+ 25 MG Oral TabletSY5abf6586-c2c7-4f4e-9f07-3c38582a33ad4
979485Losartan K+ 25 MG Oral TabletSYc80b36c2-fa22-e7a9-e053-2a95a90ae21e4
979485Losartan Pot 25 MG Oral TabletSY5abf6586-c2c7-4f4e-9f07-3c38582a33ad4
979485Losartan Pot 25 MG Oral TabletSYc80b36c2-fa22-e7a9-e053-2a95a90ae21e4
979485losartan potassium 25 MG Oral TabletPSN97a50b38-f5b3-0a96-e053-2995a90a345f3
979485losartan potassium 25 MG Oral TabletPSN9c0809dc-cbdd-1a33-e053-2995a90a48253
979485losartan potassium 25 MG Oral TabletPSN435c5544-491b-476a-b950-712b2c18e3343
979485losartan potassium 25 MG Oral TabletSCD97a50b38-f5b3-0a96-e053-2995a90a345f3
979485losartan potassium 25 MG Oral TabletSCD9c0809dc-cbdd-1a33-e053-2995a90a48253
979485losartan potassium 25 MG Oral TabletSCD435c5544-491b-476a-b950-712b2c18e3343
979485Losartan K+ 25 MG Oral TabletSY435c5544-491b-476a-b950-712b2c18e3343
979485Losartan K+ 25 MG Oral TabletSY97a50b38-f5b3-0a96-e053-2995a90a345f3
979485Losartan K+ 25 MG Oral TabletSY9c0809dc-cbdd-1a33-e053-2995a90a48253
979485Losartan Pot 25 MG Oral TabletSY9c0809dc-cbdd-1a33-e053-2995a90a48253
979485Losartan Pot 25 MG Oral TabletSY97a50b38-f5b3-0a96-e053-2995a90a345f3
979485Losartan Pot 25 MG Oral TabletSY435c5544-491b-476a-b950-712b2c18e3343
979485losartan potassium 25 MG Oral TabletPSNd358499d-5ebb-75b2-e053-2a95a90a42232
979485losartan potassium 25 MG Oral TabletSCDd358499d-5ebb-75b2-e053-2a95a90a42232
979485Losartan K+ 25 MG Oral TabletSYd358499d-5ebb-75b2-e053-2a95a90a42232
979485Losartan Pot 25 MG Oral TabletSYd358499d-5ebb-75b2-e053-2a95a90a42232
979485losartan potassium 25 MG Oral TabletPSN2c810cde-fa40-4772-806e-c31809e6bbfb1
979485losartan potassium 25 MG Oral TabletPSN3bcbcb6c-ee8d-44b1-9c78-92712291e8911
979485losartan potassium 25 MG Oral TabletPSN26cfdc1c-d017-ed31-e063-6394a90a54df1
979485losartan potassium 25 MG Oral TabletSCD2c810cde-fa40-4772-806e-c31809e6bbfb1
979485losartan potassium 25 MG Oral TabletSCD26cfdc1c-d017-ed31-e063-6394a90a54df1
979485losartan potassium 25 MG Oral TabletSCD3bcbcb6c-ee8d-44b1-9c78-92712291e8911
979485Losartan K+ 25 MG Oral TabletSY26cfdc1c-d017-ed31-e063-6394a90a54df1
979485Losartan K+ 25 MG Oral TabletSY3bcbcb6c-ee8d-44b1-9c78-92712291e8911
979485Losartan K+ 25 MG Oral TabletSY2c810cde-fa40-4772-806e-c31809e6bbfb1
979485Losartan Pot 25 MG Oral TabletSY3bcbcb6c-ee8d-44b1-9c78-92712291e8911
979485Losartan Pot 25 MG Oral TabletSY26cfdc1c-d017-ed31-e063-6394a90a54df1
979485Losartan Pot 25 MG Oral TabletSY2c810cde-fa40-4772-806e-c31809e6bbfb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-700-0531722070005500 TABLET, FILM COATED in 1 BOTTLE (31722-700-05) 2015-08-190000-00-00NoNoCurrent
31722-700-10317220700101000 TABLET, FILM COATED in 1 BOTTLE (31722-700-10) 2015-08-190000-00-00NoNoCurrent
31722-700-303172207003030 TABLET, FILM COATED in 1 BOTTLE (31722-700-30) 2015-08-190000-00-00NoNoCurrent
31722-700-603172207006060 TABLET, FILM COATED in 1 BOTTLE (31722-700-60) 2015-08-190000-00-00NoNoCurrent
31722-700-903172207009090 TABLET, FILM COATED in 1 BOTTLE (31722-700-90) 2015-08-190000-00-00NoNoCurrent