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USFDA APPLICATION NUMBER - 9170 / DOSAGE - TABLET;ORAL - 50MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Primidone(UNII: 13AFD7670Q) (Primidone - UNII:13AFD7670Q) | Primidone | 50mg | 250mg |
Inactive Ingredients
| Ingredient Name | Major Pharmaceuticals | McKesson Contract Packaging | NCS HealthCare of KY, Inc dba Vangard Labs | AvKARE, Inc. | Impax Generics | Par Pharmaceutical | West-ward Pharmaceutical Corp | Oceanside Pharmaceuticals |
|---|---|---|---|---|---|---|---|---|
| ACACIA(5C5403N26O) | ||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||
| FD&C YELLOW NO. 5(I753WB2F1M) | ||||||||
| ferric oxide yellow(EX438O2MRT) | ||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||
| METHYLCELLULOSE (100 CPS)(4GFU244C4J) | ||||||||
| METHYLCELLULOSE (15 MPA.S)(NPU9M2E6L8) | ||||||||
| METHYLCELLULOSE (400 CPS)(O0GN6F9B2Y) | ||||||||
| METHYLCELLULOSE (400 MPA.S)(O0GN6F9B2Y) | ||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||
| POVIDONE(FZ989GH94E) | ||||||||
| sodium lauryl sulfate(368GB5141J) | ||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||
| STEARIC ACID(4ELV7Z65AP) | ||||||||
| talc(7SEV7J4R1U) | ||||||||
| WATER(059QF0KO0R) |
