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USFDA APPLICATION NUMBER - 20973 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| RABEPRAZOLE SODIUM(UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL) | RABEPRAZOLE SODIUM | 20mg |
Inactive Ingredients
| Ingredient Name | Bryant Ranch Prepack | Cardinal Health | Lake Erie Medical & Surgical Supplies DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Produtcs LLC |
|---|---|---|---|---|
| CARNAUBA WAX(R12CBM0EIZ) | ||||
| CROSPOVIDONE(2S7830E561) | ||||
| CROSPOVIDONE(68401960MK) | ||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||
| FERRIC OXIDE RED(1K09F3G675) | ||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||||
| HYDROXYPROPYL CELLULOSE(RFW2ET671P) | ||||
| HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| MANNITOL(3OWL53L36A) | ||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||
| SODIUM HYDROXIDE(55X04QC32I) | ||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||
| TALC(7SEV7J4R1U) | ||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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