FDA.reportPublic FDA data

Losartan Potassium and Hydrochlorothiazide

Product NDC
71335-2127
11-digit product format
713352127
Labeler code
71335
Product ID
71335-2127_9fb29467-4366-4f70-9f7f-72c3acede1e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204901
Marketing category
ANDA
Marketing start
2018-02-15
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
12.5; 50 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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 and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
LOSARTAN POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, 3ST302B24A
Rxcui979468

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2127-1Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED90101
71335-2127-2Losartan Potassium and Hydrochlorothiazide60 in 1 BOTTLETABLET, FILM COATED60101
71335-2127-3Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED30101
71335-2127-4Losartan Potassium and Hydrochlorothiazide120 in 1 BOTTLETABLET, FILM COATED120101
71335-2127-5Losartan Potassium and Hydrochlorothiazide58 in 1 BOTTLETABLET, FILM COATED58101
71335-2127-6Losartan Potassium and Hydrochlorothiazide100 in 1 BOTTLETABLET, FILM COATED100101
71335-2127-7Losartan Potassium and Hydrochlorothiazide180 in 1 BOTTLETABLET, FILM COATED180101
71335-2127-8Losartan Potassium and Hydrochlorothiazide1000 in 1 BOTTLETABLET, FILM COATED1000101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2127LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 8 package rows20231117_42942482-1f54-4c7f-9d5f-4aaf20abb3e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN42942482-1f54-4c7f-9d5f-4aaf20abb3e3101
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCD42942482-1f54-4c7f-9d5f-4aaf20abb3e3101
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSY42942482-1f54-4c7f-9d5f-4aaf20abb3e3101
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSY42942482-1f54-4c7f-9d5f-4aaf20abb3e3101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2127-17133521270190 TABLET, FILM COATED in 1 BOTTLE (71335-2127-1) 2022-07-180000-00-00NoNoCurrent
71335-2127-27133521270260 TABLET, FILM COATED in 1 BOTTLE (71335-2127-2) 2022-07-180000-00-00NoNoCurrent
71335-2127-37133521270330 TABLET, FILM COATED in 1 BOTTLE (71335-2127-3) 2022-07-180000-00-00NoNoCurrent
71335-2127-471335212704120 TABLET, FILM COATED in 1 BOTTLE (71335-2127-4) 2022-07-180000-00-00NoNoCurrent
71335-2127-57133521270558 TABLET, FILM COATED in 1 BOTTLE (71335-2127-5) 2022-07-180000-00-00NoNoCurrent
71335-2127-671335212706100 TABLET, FILM COATED in 1 BOTTLE (71335-2127-6) 2022-07-180000-00-00NoNoCurrent
71335-2127-771335212707180 TABLET, FILM COATED in 1 BOTTLE (71335-2127-7) 2022-07-180000-00-00NoNoCurrent
71335-2127-8713352127081000 TABLET, FILM COATED in 1 BOTTLE (71335-2127-8) 2022-07-180000-00-00NoNoCurrent