Losartan Potassium and Hydrochlorothiazide

Product NDC
70518-2737
11-digit product format
705182737
Labeler code
70518
Product ID
70518-2737_4a8ce1d4-2226-613c-e063-6394a90ac366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091629
Marketing category
ANDA
Marketing start
2020-05-12
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
25; 100 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1
LOSARTAN POTASSIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, 3ST302B24A
Rxcui979471

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2737-02023-03-13C16284748780-1f386c64a-0b9b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2737-12023-03-13C16284748780-1f386c64a-0b9b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2737-02023-01-30C16284748780-1f386c64a-0b9b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2737-12023-01-30C16284748780-1f386c64a-0b9b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2737-0Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013
70518-2737-1Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-2737-2Losartan Potassium and Hydrochlorothiazide30 in 1 BLISTER PACKTABLET, FILM COATED3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2737LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 3 package rows20250523_9f9cd7a7-be95-4ea8-8247-eb7ecbd36936.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9f9cd7a7-be95-4ea8-8247-eb7ecbd3693613
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCD9f9cd7a7-be95-4ea8-8247-eb7ecbd3693613
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSY9f9cd7a7-be95-4ea8-8247-eb7ecbd3693613
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSY9f9cd7a7-be95-4ea8-8247-eb7ecbd3693613
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSY9f9cd7a7-be95-4ea8-8247-eb7ecbd3693613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2737-07051827370030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2737-0) 2020-05-120000-00-00NoNoCurrent
70518-2737-17051827370190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2737-1) 2020-05-220000-00-00NoNoCurrent
70518-2737-27051827370230 in 1 BLISTER PACKHistorical