rabeprazole Delayed Release Oral Capsule

Brand(s)
Aciphex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fsc Laboratories, Inc (2014-09-23)
Oldest Current Product
2014-10-01
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL CAPSULE\RABEPRAZOLE
FDAOB
ORAL\CAPSULE, DELAYED RELEASE\RABEPRAZOLE SODIUM
SPL Active
ORAL\CAPSULE, DELAYED RELEASE\RABEPRAZOLE SODIUM
SPL Moiety
ORAL\CAPSULE, DELAYED RELEASE\RABEPRAZOLE

product(s) by strength(s)

rabeprazole sodium 10 mg delayed release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1135510210AciphexNDAFsc Laboratories, Inc2014-10-01RABEPRAZOLE SODIUMORALCAPSULE, DELAYED RELEASENDA2047365a1edab0-a602-4786-9ef5-40063f9efdb4

rabeprazole sodium 5 mg delayed release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1135510205AciphexNDAFsc Laboratories, Inc2014-10-01RABEPRAZOLE SODIUMORALCAPSULE, DELAYED RELEASENDA2047365a1edab0-a602-4786-9ef5-40063f9efdb4

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA204736ACIPHEX SPRINKLEEISAI INC2013-03-26PEDIATRIC EXCLUSIVITY [2016-09-26]
NEW DOSAGE FORM [2016-03-26]
NDA204736_001, NDA204736_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204736_001RXRABEPRAZOLE SODIUM (5MG)ORALCAPSULE, DELAYED RELEASEFalse2013-03-26ACIPHEX SPRINKLE
2NDA204736_002RXRABEPRAZOLE SODIUM (10MG)ORALCAPSULE, DELAYED RELEASETrue2013-03-26ACIPHEX SPRINKLE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
15a1edab0-a602-4786-9ef5-40063f9efdb4 (view SPL)These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX. ACIPHEX (rabeprazole sodium) Delayed-Release Tablets, for oral use ACIPHEX Sprinkle (rabeprazole sodium) Delayed-Release Capsules, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionFsc Laboratories, Inc2014-09-231135510205, 135510210

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII