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USFDA APPLICATION NUMBER - 22281 / DOSAGE - CAPSULE;ORAL - 20MG;1.1GM
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| OMEPRAZOLE(UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) | OMEPRAZOLE | 20mg |
| SODIUM BICARBONATE(UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) | SODIUM BICARBONATE | 1100mg |
Inactive Ingredients
| Ingredient Name | Akron Pharma Inc | AvKARE, Inc. | Cipla USA Inc. | Medarbor Llc | Par Pharmaceutical Inc. | Dr.Reddy's Laboratories Limited | Bayer HealthCare LLC | Guardian Drug Company | Northstar Rx LLC | Oceanside Pharmaceuticals | Prasco Laboratories | HyVee Inc | Topco Associates LLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | |||||||||||||
| ammonia(5138Q19F1X) | |||||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | |||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||
| GELATIN(2G86QN327L) | |||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | |||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||
| POLYSORBATE 80(6OZP39ZG8H) | |||||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||
| SHELLAC(MB5IUD6JUA) | |||||||||||||
| silicon dioxide(ETJ7Z6XBU4) | |||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | |||||||||||||
| SODIUM(9NEZ333N27) | |||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
