RAMELTEON- ramelteon tablet 
Zydus Lifesciences Limited

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RAMELTEON TABLETS

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1495-3

Ramelteon Tablets, 8 mg

30 Tablets

Rx only

Ramelteon Tablets
RAMELTEON 
ramelteon tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1495
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAMELTEON (UNII: 901AS54I69) (RAMELTEON - UNII:901AS54I69) RAMELTEON8 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (light yellow to beige coloured) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code 1344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1495-330 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2019
2NDC:70771-1495-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2019
3NDC:70771-1495-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21156707/23/2019
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1495) , MANUFACTURE(70771-1495)

Revised: 9/2023
Document Id: ccb643ba-3ba2-485e-9419-339d5c68dc1a
Set id: 14ba7994-476a-4978-8cac-29989335a63c
Version: 4
Effective Time: 20230927
 
Zydus Lifesciences Limited