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USFDA APPLICATION NUMBER - 87003 / DOSAGE - TABLET;ORAL - 325MG;5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ACETAMINOPHEN(UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) | ACETAMINOPHEN | 325mg |
| OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) | OXYCODONE HYDROCHLORIDE | 5mg |
Inactive Ingredients
| Ingredient Name | Avera McKennan Hospital | AvKARE, Inc. | Bryant Ranch Prepack | DIRECT RX | Elite Laboratories, Inc. | Lake Erie Medical DBA Quality Care Products LLC | Mayne Pharma Inc. | Mylan Pharmaceuticals Inc. | Par Pharmaceutical | PD-Rx Pharmaceuticals, Inc. | STAT RX USA LLC | Actavis Pharma, Inc. | Major Pharmaceuticals | Mckesson Rxpak Inc | Sun Pharmaceutical Industries, Inc. | West-Ward Pharmaceuticals Corp. | McKesson Corporation | Xiromed, LLC | Alvogen, Inc. | Medsource Pharmaceuticals | American Health Packaging | McKesson Corporation dba SKY Packaging | Precision Dose, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||||||||||||||
| crospovidone (15 mpa.s at 5%)(68401960MK) | |||||||||||||||||||||||
| CROSPOVIDONE(2S7830E561) | |||||||||||||||||||||||
| CROSPOVIDONE(68401960MK) | |||||||||||||||||||||||
| CROSPOVIDONE, UNSPECIFIED(2S7830E561) | |||||||||||||||||||||||
| D&C RED NO. 27(2LRS185U6K) | |||||||||||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||||||||||
| POVIDONE K30(U725QWY32X) | |||||||||||||||||||||||
| POVIDONE(FZ989GH94E) | |||||||||||||||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||||||||||||||||||||
| povidones(FZ989GH94E) | |||||||||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||||||||||||
| Starch, Pregelatinized Corn(O8232NY3SJ) | |||||||||||||||||||||||
| stearic acid(4ELV7Z65AP) | |||||||||||||||||||||||
| TALC(7SEV7J4R1U) | |||||||||||||||||||||||
| WATER(059QF0KO0R) |
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