RABEPRAZOLE SODIUM

These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE sodium delayed-release tablets, for oral useInitial U.S. Approval: 1999

Approved

Approval ID

c837a391-cb1c-4170-8b90-f42c152cbce0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 22, 2019

Manufacturers

FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

RABEPRAZOLE SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50090-1424

Application NumberANDA078964

Product Classification

Marketing Category

C73584

Generic Name

RABEPRAZOLE SODIUM

Product Specifications

Route of AdministrationORAL

Effective DateJuly 7, 2018

FDA Product Classification

INGREDIENTS (19)

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

DIACETYLATED MONOGLYCERIDESInactive

Code: 5Z17386USF

Classification: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4B

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive

Code: 87Y6436BKR

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

RABEPRAZOLE SODIUMActive

Quantity: 20 mg in 1 1

Code: 3L36P16U4R

Classification: ACTIB

MAGNESIUM OXIDEInactive

Code: 3A3U0GI71G

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Drug Labeling Information

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 7/2/2018

RECENT MAJOR CHANGES

Warnings and Precautions, Fundic Gland Polyps (5.10) 06/2018

Key Highlight

Warnings and Precautions, Fundic Gland Polyps (5.10) 06/2018

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RABEPRAZOLE SODIUM

Products 1

RABEPRAZOLE SODIUM

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Drug Labeling Information

RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

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