MedPath
FDA Approval

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Direct_Rx
DUNS: 079254320
Effective Date
June 28, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Losartan(100 mg in 1 1)
Hydrochlorothiazide(12.5 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Direct_Rx

079254320

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Direct_Rx

Direct_Rx

Direct_Rx

079254320

Products5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Details

NDC Product Code
72189-167
Application Number
ANDA078245
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 28, 2023
LosartanActive
Code: 3ST302B24AClass: ACTIBQuantity: 100 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Details

NDC Product Code
72189-129
Application Number
ANDA201845
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 28, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
LosartanActive
Code: 3ST302B24AClass: ACTIBQuantity: 50 mg in 1 1

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Details

NDC Product Code
72189-139
Application Number
ANDA201845
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 28, 2023
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
LosartanActive
Code: 3ST302B24AClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Details

NDC Product Code
72189-098
Application Number
ANDA077157
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 28, 2023
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LosartanActive
Code: 3ST302B24AClass: ACTIBQuantity: 100 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Details

NDC Product Code
72189-012
Application Number
ANDA091629
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 28, 2023
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LosartanActive
Code: 3ST302B24AClass: ACTIBQuantity: 50 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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