Carvedilol

Manufacturing Establishments (1)

Glenmark Pharmaceuticals Limited

Labeler

Glenmark Pharmaceuticals Inc., USA

DUNS Number

862603186

Products (4)

NDC Product Code

68462-165

Application Number

ANDA078251

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 29, 2023

Ingredients

CarvedilolActive

Code: 0K47UL67F2Class: ACTIBQuantity: 25 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Carvedilol

NDC Product Code

68462-164

Application Number

ANDA078251

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 29, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CarvedilolActive

Code: 0K47UL67F2Class: ACTIBQuantity: 12.5 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Carvedilol

NDC Product Code

68462-162

Application Number

ANDA078251

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 29, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CarvedilolActive

Code: 0K47UL67F2Class: ACTIBQuantity: 3.125 mg in 1 1

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Carvedilol

NDC Product Code

68462-163

Application Number

ANDA078251

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 29, 2023

Ingredients

CarvedilolActive

Code: 0K47UL67F2Class: ACTIBQuantity: 6.25 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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Carvedilol

Manufacturing Establishments (1)

Products (4)

Carvedilol

Carvedilol

Carvedilol

Carvedilol