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USFDA APPLICATION NUMBER - 19810 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| OMEPRAZOLE MAGNESIUM(UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) | OMEPRAZOLE | 10mg | 2.5mg | 40mg | 20mg | 10mg |
Inactive Ingredients
| Ingredient Name | AstraZeneca Pharmaceuticals LP |
|---|---|
| ALCOHOL(3K9958V90M) | |
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |
| ANHYDROUS DEXTROSE(5SL0G7R0OK) | |
| ANHYDROUS LACTOSE(3SY5LH9PMK) | |
| BUTYL ALCOHOL(8PJ61P6TS3) | |
| D&C RED NO. 28(767IP0Y5NH) | |
| D&C RED NO. 7(ECW0LZ41X8) | |
| D&C YELLOW NO. 10(35SW5USQ3G) | |
| FD&C BLUE NO. 1(H3R47K3TBD) | |
| FD&C BLUE NO. 2(L06K8R7DQK) | |
| FD&C RED NO. 40(WZB9127XOA) | |
| FERROSOFERRIC OXIDE(XM0M87F357) | |
| GELATIN(2G86QN327L) | |
| GLYCERYL MONOSTEARATE(230OU9XXE4) | |
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |
| HYPROMELLOSES(3NXW29V3WO) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| MANNITOL(3OWL53L36A) | |
| METHACRYLIC ACID(1CS02G8656) | |
| POLYSORBATE 80(6OZP39ZG8H) | |
| SODIUM HYDROXIDE(55X04QC32I) | |
| SODIUM LAURYL SULFATE(368GB5141J) | |
| TALC(7SEV7J4R1U) | |
| TITANIUM DIOXIDE(15FIX9V2JP) | |
| TRIETHYL CITRATE(8Z96QXD6UM) | |
| XANTHAN GUM(TTV12P4NEE) |
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