FDA.reportPublic FDA data

Losartan Potassium and Hydrochlorothiazide

Product NDC
43547-425
11-digit product format
435470425
Labeler code
43547
Product ID
43547-425_0be72eb2-c56a-4721-8cb5-d9b778c3e179
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA204901
Marketing category
ANDA
Marketing start
2018-02-15
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
12.5; 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
HYDROCHLOROTHIAZIDE12.5 mg/1
LOSARTAN POTASSIUM100 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-425-03Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED308
43547-425-09Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED908
43547-425-11Losartan Potassium and Hydrochlorothiazide1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-425-03EA - Each43547-42581e37104-50f1-44b5-83d6-9b68b5374f7912018-04-19
43547-425-09EA - Each43547-42527da2317-7db6-4e06-975d-a2064908ea1112018-04-19
43547-425-11EA - Each43547-425e5a6be13-464d-430b-9927-0c75e3a2b90812018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-425LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]5Current NDC, Legacy NDC, 3 package rows20230819_6d677f9e-c0e4-4d6e-bea2-a58e986e4635.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN927315ca-211b-4976-b228-cf544f7e5259101
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD927315ca-211b-4976-b228-cf544f7e5259101
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY927315ca-211b-4976-b228-cf544f7e5259101
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY927315ca-211b-4976-b228-cf544f7e5259101
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY927315ca-211b-4976-b228-cf544f7e5259101
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCD6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCD6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCD6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSY6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSY6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSY6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSY6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSY6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSY6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSY6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSY6d677f9e-c0e4-4d6e-bea2-a58e986e46358
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNfd07d24c-6db1-4f6b-b226-68abba3a33216
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDfd07d24c-6db1-4f6b-b226-68abba3a33216
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYfd07d24c-6db1-4f6b-b226-68abba3a33216
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYfd07d24c-6db1-4f6b-b226-68abba3a33216
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYfd07d24c-6db1-4f6b-b226-68abba3a33216
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd838e918-2463-79f6-e053-2a95a90a948d3
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDd838e918-2463-79f6-e053-2a95a90a948d3
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYd838e918-2463-79f6-e053-2a95a90a948d3
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYd838e918-2463-79f6-e053-2a95a90a948d3
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYd838e918-2463-79f6-e053-2a95a90a948d3
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe0f63126-6890-48bf-9c25-444dc5974ecd1
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc6ed6f74-0eca-4f99-8c7e-dd3f56167f011
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDe0f63126-6890-48bf-9c25-444dc5974ecd1
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDc6ed6f74-0eca-4f99-8c7e-dd3f56167f011
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYe0f63126-6890-48bf-9c25-444dc5974ecd1
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYc6ed6f74-0eca-4f99-8c7e-dd3f56167f011
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYe0f63126-6890-48bf-9c25-444dc5974ecd1
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYc6ed6f74-0eca-4f99-8c7e-dd3f56167f011
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYe0f63126-6890-48bf-9c25-444dc5974ecd1
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYc6ed6f74-0eca-4f99-8c7e-dd3f56167f011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-425-034354704250330 TABLET, FILM COATED in 1 BOTTLE (43547-425-03) 2018-02-150000-00-00NoNoCurrent
43547-425-094354704250990 TABLET, FILM COATED in 1 BOTTLE (43547-425-09) 2018-02-150000-00-00NoNoCurrent
43547-425-11435470425111000 TABLET, FILM COATED in 1 BOTTLE (43547-425-11) 2018-02-150000-00-00NoNoCurrent