RABEPRAZOLE SODIUM

Product NDC
76420-223
11-digit product format
764200223
Labeler code
76420
Product ID
76420-223_e347fcb2-dbe0-193d-e053-2995a90a4784
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA204237
Marketing category
ANDA
Marketing start
2017-06-01
Substance
RABEPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
3L36P16U4RRABEPRAZOLE SODIUM117976-90-6RABEPRAZOLE SODIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-223-307642002233030 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-223-30) 2022-07-07NoNoHistorical
76420-223-607642002236060 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-223-60) 2022-07-07NoNoHistorical
76420-223-907642002239090 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-223-90) 2022-07-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RABEPRAZOLE SODIUMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2022-07-07HUMAN PRESCRIPTION DRUG LABEL1