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) |
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