Pantoprazole Sodium

Registrants1

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

Ranbaxy Pharmaceuticals Inc.

DUNS Number

937890044

Manufacturing Establishments2

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

Ohm Laboratories Inc.

Labeler

Ranbaxy Pharmaceuticals Inc.

Registrant

Ranbaxy Pharmaceuticals Inc.

DUNS Number

184769029

Ranbaxy Laboratories Limited

Labeler

Ranbaxy Pharmaceuticals Inc.

Registrant

Ranbaxy Pharmaceuticals Inc.

DUNS Number

650441632

Products2

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

Product Details

NDC Product Code

63304-967

Application Number

ANDA200794

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 20, 2015

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONESInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

PantoprazoleActive

Code: 6871619Q5XClass: ACTIMQuantity: 20 mg in 1 1

CALCIUM STEARATEInactive

Code: 776XM7047LClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE H)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT