USFDA APPLICATION NUMBER - 21742 / DOSAGE - TABLET;ORAL - EQ 5MG BASE
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
NEBIVOLOL HYDROCHLORIDE(UNII: JGS34J7L9I) (NEBIVOLOL - UNII:030Y90569U) | NEBIVOLOL | 20mg | 10mg | 5mg |
Inactive Ingredients
Ingredient Name | A-S Medication Solutions | Amerigen Pharmaceuticals Inc. | Avera McKennan Hospital | Modavar Pharmaceuticals LLC | Torrent Pharmaceuticals Limited | Bryant Ranch Prepack | Cardinal Health | Glenmark Pharmaceuticals Inc., USA | Major Pharmaceuticals | Solco Healthcare US, LLC | Unichem Pharmaceuticals (USA), Inc. |
---|---|---|---|---|---|---|---|---|---|---|---|
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||
CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||
CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9) | |||||||||||
D&C RED NO. 27(2LRS185U6K) | |||||||||||
FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||
FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | |||||||||||
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | |||||||||||
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |||||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||
HYPROMELLOSES(3NXW29V3WO) | |||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||
MAGNESIUM STEARATE(70097M6I30) | |||||||||||
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y) | |||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||
polysorbate 80(6OZP39ZG8H) | |||||||||||
POVIDONE K30(U725QWY32X) | |||||||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||
SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||
SODIUM LAURYL SULFOACETATE(D0Y70F2B9J) | |||||||||||
STARCH, CORN(O8232NY3SJ) | |||||||||||
TALC(7SEV7J4R1U) |
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