MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule 
MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet, film coated 
Zydus Lifesciences Limited

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Mycophenolate Mofetil Capsules

Mycophenolate Mofetil Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-680-01 in bottle of 100 capsules

Mycophenolate Mofetil Capsules, 250 mg

Rx only

100 capsules

Mycophenolate Mofetil Capsules, 250 mg

NDC 65841-681-01 in bottle of 100 tablets

Mycophenolate Mofetil Tablets, 500 mg

Rx only

100 tablets

Mycophenolate Mofetil Tablets, 500 mg
MYCOPHENOLATE MOFETIL 
mycophenolate mofetil capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-680
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T) MYCOPHENOLATE MOFETIL250 mg
Inactive Ingredients
Ingredient NameStrength
AMINOMETRADINE (UNII: PPM8SX5Q3V)  
AMINOPENTAMIDE SULFATE (UNII: 20P9NI883O)  
AMINOPTERIN SODIUM (UNII: FZU1QI13O9)  
AMOCARZINE (UNII: 99807U412Y)  
AMOTOSALEN HYDROCHLORIDE (UNII: 67B255SI5F)  
AMPHOTERICIN B (UNII: 7XU7A7DROE)  
AMPICILLIN SODIUM (UNII: JFN36L5S8K)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
NAPIRIMUS (UNII: 45081SG6XT)  
GELATIN (UNII: 2G86QN327L)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorBLUE (OPAQUE BLUE) , WHITE (OPAQUE WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 130
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-680-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/200907/31/2012
2NDC:65841-680-19120 in 1 BOTTLE; Type 0: Not a Combination Product05/04/200907/31/2012
3NDC:65841-680-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/04/200907/31/2012
4NDC:65841-680-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/04/200907/31/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06543305/04/200907/31/2012
MYCOPHENOLATE MOFETIL 
mycophenolate mofetil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-681
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T) MYCOPHENOLATE MOFETIL500 mg
Inactive Ingredients
Ingredient NameStrength
AMINOMETRADINE (UNII: PPM8SX5Q3V)  
AMINOPENTAMIDE SULFATE (UNII: 20P9NI883O)  
AMINOPROMAZINE (UNII: S9SDD93U5U)  
AMINOPROMAZINE MONOFUMARATE (UNII: 9KWA4W69IW)  
AMINOPTERIN SODIUM (UNII: FZU1QI13O9)  
AMINOSALICYLIC ACID (UNII: 5B2658E0N2)  
AMOCARZINE (UNII: 99807U412Y)  
AMOPROXAN (UNII: 27RL57FCYM)  
ANDROMEDA POLIFOLIA LEAF (UNII: V71OV33C26)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (CAPSULE) Size18mm
FlavorImprint Code ZA49
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-681-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/200907/31/2012
2NDC:65841-681-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/04/200907/31/2012
3NDC:65841-681-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/04/200907/31/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06547705/04/200907/31/2012
Labeler - Zydus Lifesciences Limited (918596198)

Revised: 7/2024
Document Id: 55a2bba7-2a53-4e26-a9c5-e2cc5ca5051c
Set id: 56428c8f-8a4b-4cbf-93f1-28d8b5cfb51a
Version: 2
Effective Time: 20240724
 
Zydus Lifesciences Limited