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USFDA APPLICATION NUMBER - 21957 / DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) | ESOMEPRAZOLE | 40mg | 40mg | 20mg |
Inactive Ingredients
| Ingredient Name | Cardinal Health |
|---|---|
| ALCOHOL(3K9958V90M) | |
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |
| ANHYDROUS DEXTROSE(5SL0G7R0OK) | |
| BUTYL ALCOHOL(8PJ61P6TS3) | |
| D&C RED NO. 28(767IP0Y5NH) | |
| D&C YELLOW NO. 10(35SW5USQ3G) | |
| FD&C BLUE NO. 1(H3R47K3TBD) | |
| FD&C RED NO. 40(WZB9127XOA) | |
| FERRIC OXIDE YELLOW(EX438O2MRT) | |
| GELATIN(2G86QN327L) | |
| GLYCERYL MONOSTEARATE(230OU9XXE4) | |
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |
| HYPROMELLOSES(3NXW29V3WO) | |
| ISOPROPYL ALCOHOL(ND2M416302) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| METHACRYLIC ACID(1CS02G8656) | |
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |
| POLYSORBATE 80(6OZP39ZG8H) | |
| POTASSIUM SORBATE(1VPU26JZZ4) | |
| POVIDONES(FZ989GH94E) | |
| SODIUM HYDROXIDE(55X04QC32I) | |
| TALC(7SEV7J4R1U) | |
| TITANIUM DIOXIDE(15FIX9V2JP) | |
| TRIETHYL CITRATE(8Z96QXD6UM) | |
| WATER(059QF0KO0R) |
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