
USFDA APPLICATION NUMBER - 5010 / DOSAGE - TABLET;ORAL - 100MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Meperidine Hydrochloride(UNII: N8E7F7Q170) (Meperidine - UNII:9E338QE28F) | Meperidine Hydrochloride | 100mg | 50mg |
Inactive Ingredients
| Ingredient Name | sanofi-aventis U.S. LLC | Bryant Ranch Prepack | Validus Pharmaceuticals LLC | Caraco Pharmaceutical Laboratories, Ltd. | Mikart, LLC | Qualitest Pharmaceuticals | Teva Pharmaceuticals USA, Inc. |
|---|---|---|---|---|---|---|---|
| Anhydrous Dibasic Calcium Phosphate(L11K75P92J) | |||||||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J) | |||||||
| Calcium Sulfate(WAT0DDB505) | |||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||
| D&C RED NO. 27(2LRS185U6K) | |||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | |||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||
| STARCH, CORN(O8232NY3SJ) | |||||||
| STEARIC ACID(4ELV7Z65AP) | |||||||
| Talc(7SEV7J4R1U) |