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 use Initial U.S. Approval: 1999
Approved
Approval ID
12eaf996-db61-41d6-82e1-fa6196435603
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 26, 2020
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
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 Code76420-107
Application NumberANDA205761
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rabeprazole Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2020
FDA Product Classification
INGREDIENTS (17)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM HYDROXIDEInactive
Code: NBZ3QY004S
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403C
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RABEPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 3L36P16U4R
Classification: ACTIB