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Losartan potassium Tablets, 25 mg

Losartan Potassium Tablets Rx Only These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets USP, for oral use Rx Only Initial U.S. Approval: 1995

Approved
Approval ID

67828219-e7e2-48f5-9cde-9521e2147222

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 4, 2020

Manufacturers
FDA

Aphena Pharma Solutions - Tennessee, LLC

DUNS: 128385585

Products 2

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

losartan potassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71610-418
Application NumberANDA201170
Product Classification
M
Marketing Category
C73584
G
Generic Name
losartan potassium
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2020
FDA Product Classification

INGREDIENTS (13)

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 50 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT

losartan potassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71610-417
Application NumberANDA201170
Product Classification
M
Marketing Category
C73584
G
Generic Name
losartan potassium
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2020
FDA Product Classification

INGREDIENTS (13)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 25 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB

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Losartan potassium Tablets, 25 mg - FDA Drug Approval Details