FDA.reportPublic FDA data

Losartan Potassium

Product NDC
31722-701
11-digit product format
317220701
Labeler code
31722
Product ID
31722-701_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
50 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 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
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-701-05Losartan Potassium500 in 1 BOTTLETABLET, FILM COATED5006
31722-701-10Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED10006
31722-701-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED306
31722-701-60Losartan Potassium60 in 1 BOTTLETABLET, FILM COATED606
31722-701-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-701-10EA - Each31722-701a5cc9cef-2f1a-473d-bc52-0d1cff8a0f3b12015-12-02
31722-701-30EA - Each31722-7011842cd8e-d330-4841-b80e-80f2e1a43fed12016-01-13
31722-701-90EA - Each31722-701f77045b6-8dcb-4b6b-a13b-6751f5b8a0a812015-12-02

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
31722-701LOSARTAN 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
979492losartan potassium 50 MG Oral TabletPSNabb56236-f2fe-45b5-93ac-35fd661f899216
979492losartan potassium 50 MG Oral TabletSCDabb56236-f2fe-45b5-93ac-35fd661f899216
979492Losartan K+ 50 MG Oral TabletSYabb56236-f2fe-45b5-93ac-35fd661f899216
979492Losartan Pot 50 MG Oral TabletSYabb56236-f2fe-45b5-93ac-35fd661f899216
979492losartan potassium 50 MG Oral TabletPSNf29cc61a-afba-4ecb-8043-5f103872f1ae11
979492losartan potassium 50 MG Oral TabletSCDf29cc61a-afba-4ecb-8043-5f103872f1ae11
979492Losartan K+ 50 MG Oral TabletSYf29cc61a-afba-4ecb-8043-5f103872f1ae11
979492Losartan Pot 50 MG Oral TabletSYf29cc61a-afba-4ecb-8043-5f103872f1ae11
979492losartan potassium 50 MG Oral TabletPSN3ee3240f-78a1-4fd2-a779-c2269371172110
979492losartan potassium 50 MG Oral TabletSCD3ee3240f-78a1-4fd2-a779-c2269371172110
979492Losartan K+ 50 MG Oral TabletSY3ee3240f-78a1-4fd2-a779-c2269371172110
979492Losartan Pot 50 MG Oral TabletSY3ee3240f-78a1-4fd2-a779-c2269371172110
979492losartan potassium 50 MG Oral TabletPSNfe1df76d-4925-444d-8e30-9dd07f205fb77
979492losartan potassium 50 MG Oral TabletSCDfe1df76d-4925-444d-8e30-9dd07f205fb77
979492Losartan K+ 50 MG Oral TabletSYfe1df76d-4925-444d-8e30-9dd07f205fb77
979492Losartan Pot 50 MG Oral TabletSYfe1df76d-4925-444d-8e30-9dd07f205fb77
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 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 TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
979480Losartan K+ 100 MG Oral TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
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 TabletSYcafd54e8-42a8-474c-8ea8-49ec74c2b0d36
979480Losartan Pot 100 MG Oral TabletSY0f3a6984-e601-4a74-9910-49ee5e352d6b6
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
979492losartan potassium 50 MG Oral TabletPSN0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7385
979492losartan potassium 50 MG Oral TabletSCD0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7385
979492Losartan K+ 50 MG Oral TabletSY0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7385
979492Losartan Pot 50 MG Oral TabletSY0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7385
979492losartan potassium 50 MG Oral TabletPSN6eec2a4c-6b5c-11a5-e053-2991aa0aa56b4
979492losartan potassium 50 MG Oral TabletPSNc80b3a28-ef15-5902-e053-2995a90a06d74
979492losartan potassium 50 MG Oral TabletPSNaeb4ce44-ab34-4f0e-a674-de42d404d1044
979492losartan potassium 50 MG Oral TabletSCDc80b3a28-ef15-5902-e053-2995a90a06d74
979492losartan potassium 50 MG Oral TabletSCD6eec2a4c-6b5c-11a5-e053-2991aa0aa56b4
979492losartan potassium 50 MG Oral TabletSCDaeb4ce44-ab34-4f0e-a674-de42d404d1044
979492Losartan K+ 50 MG Oral TabletSY6eec2a4c-6b5c-11a5-e053-2991aa0aa56b4
979492Losartan K+ 50 MG Oral TabletSYc80b3a28-ef15-5902-e053-2995a90a06d74
979492Losartan K+ 50 MG Oral TabletSYaeb4ce44-ab34-4f0e-a674-de42d404d1044
979492Losartan Pot 50 MG Oral TabletSYc80b3a28-ef15-5902-e053-2995a90a06d74
979492Losartan Pot 50 MG Oral TabletSYaeb4ce44-ab34-4f0e-a674-de42d404d1044
979492Losartan Pot 50 MG Oral TabletSY6eec2a4c-6b5c-11a5-e053-2991aa0aa56b4
979492losartan potassium 50 MG Oral TabletPSNa1123700-f4c7-2b62-e053-2a95a90a87d63
979492losartan potassium 50 MG Oral TabletPSNa11075f1-f7d0-0c3d-e053-2995a90a0c9d3
979492losartan potassium 50 MG Oral TabletPSNadc984d5-91d6-ef17-e053-2a95a90a75713
979492losartan potassium 50 MG Oral TabletPSN90ff8d06-18af-4756-891e-0a029bcc69e63
979492losartan potassium 50 MG Oral TabletSCDa1123700-f4c7-2b62-e053-2a95a90a87d63
979492losartan potassium 50 MG Oral TabletSCDa11075f1-f7d0-0c3d-e053-2995a90a0c9d3
979492losartan potassium 50 MG Oral TabletSCD90ff8d06-18af-4756-891e-0a029bcc69e63
979492losartan potassium 50 MG Oral TabletSCDadc984d5-91d6-ef17-e053-2a95a90a75713
979492Losartan K+ 50 MG Oral TabletSY90ff8d06-18af-4756-891e-0a029bcc69e63
979492Losartan K+ 50 MG Oral TabletSYa11075f1-f7d0-0c3d-e053-2995a90a0c9d3
979492Losartan K+ 50 MG Oral TabletSYadc984d5-91d6-ef17-e053-2a95a90a75713
979492Losartan K+ 50 MG Oral TabletSYa1123700-f4c7-2b62-e053-2a95a90a87d63
979492Losartan Pot 50 MG Oral TabletSY90ff8d06-18af-4756-891e-0a029bcc69e63
979492Losartan Pot 50 MG Oral TabletSYa1123700-f4c7-2b62-e053-2a95a90a87d63
979492Losartan Pot 50 MG Oral TabletSYadc984d5-91d6-ef17-e053-2a95a90a75713
979492Losartan Pot 50 MG Oral TabletSYa11075f1-f7d0-0c3d-e053-2995a90a0c9d3
979492losartan potassium 50 MG Oral TabletPSNaaf943ff-d6af-8ce2-e053-2995a90a7b762
979492losartan potassium 50 MG Oral TabletPSNa5b5da65-a4d5-1bd5-e053-2a95a90a6a602
979492losartan potassium 50 MG Oral TabletSCDa5b5da65-a4d5-1bd5-e053-2a95a90a6a602
979492losartan potassium 50 MG Oral TabletSCDaaf943ff-d6af-8ce2-e053-2995a90a7b762
979492Losartan K+ 50 MG Oral TabletSYa5b5da65-a4d5-1bd5-e053-2a95a90a6a602
979492Losartan K+ 50 MG Oral TabletSYaaf943ff-d6af-8ce2-e053-2995a90a7b762
979492Losartan Pot 50 MG Oral TabletSYa5b5da65-a4d5-1bd5-e053-2a95a90a6a602
979492Losartan Pot 50 MG Oral TabletSYaaf943ff-d6af-8ce2-e053-2995a90a7b762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-701-0531722070105500 TABLET, FILM COATED in 1 BOTTLE (31722-701-05) 2015-08-190000-00-00NoNoCurrent
31722-701-10317220701101000 TABLET, FILM COATED in 1 BOTTLE (31722-701-10) 2015-08-190000-00-00NoNoCurrent
31722-701-303172207013030 TABLET, FILM COATED in 1 BOTTLE (31722-701-30) 2015-08-190000-00-00NoNoCurrent
31722-701-603172207016060 TABLET, FILM COATED in 1 BOTTLE (31722-701-60) 2015-08-190000-00-00NoNoCurrent
31722-701-903172207019090 TABLET, FILM COATED in 1 BOTTLE (31722-701-90) 2015-08-190000-00-00NoNoCurrent