Losartan Potassium and Hydrochlorothiazide

Product NDC
50090-2632
11-digit product format
500902632
Labeler code
50090
Product ID
50090-2632_06d80aa9-ec51-4dfa-a25e-42c20ae5ed50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091629
Marketing category
ANDA
Marketing start
2010-10-06
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
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
HYDROCHLOROTHIAZIDE12.5 mg/1
LOSARTAN POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, 3ST302B24A
Rxcui979464, 979468, 979471

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
50090-2632-02023-02-06C16284748780-1f386c64a-0b6b-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
50090-2632-12023-02-06C16284748780-1f386c64a-0b6b-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
50090-2632-02023-01-30C16284748780-1f386c64a-0b6b-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
50090-2632-12023-01-30C16284748780-1f386c64a-0b6b-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
50090-2632-0Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9041
50090-2632-1Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED3041
50090-2632-2Losartan Potassium and Hydrochlorothiazide100 in 1 BOTTLETABLET, FILM COATED10041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2632-0EA - Each50090-2632e693ff58-6602-470b-b5e5-47edb625096112019-04-11
50090-2632-1EA - Each50090-2632eb885303-525e-429f-aa62-f1bcacb452a512019-04-11
50090-2632-2EA - Each50090-2632b01bdba0-1665-415f-9dee-e8022308dd1412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2632LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]38Current NDC, Legacy NDC, 3 package rows20241105_dc9512cf-db66-40e9-afcb-1d6a722772e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNdc9512cf-db66-40e9-afcb-1d6a722772e841
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNdc9512cf-db66-40e9-afcb-1d6a722772e841
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNdc9512cf-db66-40e9-afcb-1d6a722772e841
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDdc9512cf-db66-40e9-afcb-1d6a722772e841
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCDdc9512cf-db66-40e9-afcb-1d6a722772e841
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCDdc9512cf-db66-40e9-afcb-1d6a722772e841
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYdc9512cf-db66-40e9-afcb-1d6a722772e841
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSYdc9512cf-db66-40e9-afcb-1d6a722772e841
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYdc9512cf-db66-40e9-afcb-1d6a722772e841
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSYdc9512cf-db66-40e9-afcb-1d6a722772e841
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYdc9512cf-db66-40e9-afcb-1d6a722772e841
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSYdc9512cf-db66-40e9-afcb-1d6a722772e841
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSYdc9512cf-db66-40e9-afcb-1d6a722772e841
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSYdc9512cf-db66-40e9-afcb-1d6a722772e841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2632-05009026320090 TABLET, FILM COATED in 1 BOTTLE (50090-2632-0) 2016-11-170000-00-00NoNoCurrent
50090-2632-15009026320130 TABLET, FILM COATED in 1 BOTTLE (50090-2632-1) 2016-12-010000-00-00NoNoCurrent
50090-2632-250090263202100 in 1 BOTTLEHistorical