
USFDA APPLICATION NUMBER - 21611 / DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| OXYMORPHONE HYDROCHLORIDE(UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C) | OXYMORPHONE HYDROCHLORIDE | 5mg | 10mg |
Inactive Ingredients
| Ingredient Name | American Health Packaging | Endo Pharmaceuticals Inc. | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Par Pharmaceutical | Bryant Ranch Prepack |
|---|---|---|---|---|---|
| D&C RED NO. 30(2S42T2808B) | |||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||
| MAGNESIUM STEARATE(70097M6I30) | |||||
| STARCH, CORN(O8232NY3SJ) |
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