RABEPRAZOLE SODIUM

Product NDC
68788-8536
11-digit product format
687888536
Labeler code
68788
Product ID
68788-8536_7cadd193-627f-46b5-84f0-6d612b572ce5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204237
Marketing category
ANDA
Marketing start
2023-10-19
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
68788-8536-36878885360330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8536-3) 2023-10-19NoNoHistorical
68788-8536-66878885360660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8536-6) 2023-10-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RABEPRAZOLE SODIUMPreferred Pharmaceuticals Inc.2025-09-17HUMAN PRESCRIPTION DRUG LABEL3