ESZOPICLONE

Manufacturing Establishments (1)

Labeler

Proficient Rx LP

DUNS Number

079196022

NDC Product Code

71205-513

Application Number

ANDA208451

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2020

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

Code: UZX80K71OEClass: ACTIBQuantity: 2 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT