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USFDA APPLICATION NUMBER - 5213 / DOSAGE - TABLET;ORAL - 1.5MG;5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| HOMATROPINE METHYLBROMIDE(UNII: 68JRS2HC1C) (METHYLHOMATROPINE - UNII:P97OGJ7L1L) | HOMATROPINE METHYLBROMIDE | 1.5mg | 1.5mg in 5 |
| HYDROCODONE BITARTRATE(UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) | HYDROCODONE BITARTRATE | 5mg | 5mg in 5 |
Inactive Ingredients
| Ingredient Name | Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc. | Endo Pharmaceuticals, Inc. | Pfizer Laboratories Div Pfizer Inc |
|---|---|---|---|---|
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J) | ||||
| ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J) | ||||
| CARAMEL(T9D99G2B1R) | ||||
| CHERRY(BUC5I9595W) | ||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||
| FD&C RED NO. 40(WZB9127XOA) | ||||
| HYDROGENATED TALLOW ACID(Q8Y7S3B85M) | ||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||
| LACTOSE(J2B2A4N98G) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| METHYLPARABEN(A2I8C7HI9T) | ||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
| PROPYLPARABEN(Z8IX2SC1OH) | ||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||
| SORBITOL(506T60A25R) | ||||
| STARCH, CORN(O8232NY3SJ) | ||||
| STEARIC ACID(4ELV7Z65AP) | ||||
| SUGARCANE(81H2R5AOH3) | ||||
| TALC(7SEV7J4R1U) |
