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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