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USFDA APPLICATION NUMBER - 10721 / DOSAGE - TABLET;ORAL - 50MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| MECLIZINE HYDROCHLORIDE(UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) | MECLIZINE HYDROCHLORIDE | 50mg | 25mg | 12.5mg |
Inactive Ingredients
| Ingredient Name | Roerig | Direct_Rx | A-S Medication Solutions | Cardinal Health | Mylan Institutional Inc. | Mylan Pharmaceuticals Inc. | PD-Rx Pharmaceuticals, Inc. | St Marys Medical Park Pharmacy. | A-S Medication Solutions LLC | Amneal Pharmaceuticals of New York LLC | NCS HealthCare of KY, LLC dba Vangard Labs | NuCare Pharmaceuticals,Inc. | REMEDYREPACK INC. | St. Mary's Medical Park Pharmacy | Major Pharmaceuticals | Bioniche Animal Health USA, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | ||||||||||||||||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J) | ||||||||||||||||
| ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||||||||||||||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J) | ||||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||||||||||||||||
| CROSPOVIDONE(68401960MK) | ||||||||||||||||
| CROSPOVIDONE, UNSPECIFIED(2S7830E561) | ||||||||||||||||
| D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6) | ||||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||||||||
| SODIUM CHLORIDE(451W47IQ8X) | ||||||||||||||||
| SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE(E1W4N241FO) | ||||||||||||||||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(5QWK665956) | ||||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||||||||
| SUCROSE(C151H8M554) | ||||||||||||||||
| TALC(7SEV7J4R1U) | ||||||||||||||||
| WATER(059QF0KO0R) |
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