RIBAVIRIN - ribavirin tablet, film coated 
Aurobindo Pharma Limited

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Ribavirin Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg Bulk Tablet Label


3000 Tablets

Batch      :

Mfg         :

Expiry      :

To be repacked within six months from the date of manufacturing

NDC 65862-207-39

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Ribavirin Tablets 200 mg

Each film-coated tablet contains: Ribavirin USP 200 mg.

CAUTION: FOR REPACKAGING ONLY

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg Bulk Tablet Label
RIBAVIRIN 
ribavirin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65862-207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN200 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
TRIACETIN (UNII: XHX3C3X673)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINK (Light Pink) Scoreno score
ShapeCAPSULESize13mm
FlavorImprint Code F;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65862-207-393000 in 1 BAG; Type 0: Not a Combination Product09/17/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911109/17/2009
Labeler - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(65862-207) , MANUFACTURE(65862-207)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917647API MANUFACTURE(65862-207)

Revised: 10/2018
Document Id: 23ed6185-5712-49c6-9860-b61713e9927d
Set id: f0ee925d-fab9-49dd-8eb0-719ff2887531
Version: 3
Effective Time: 20181024
 
Aurobindo Pharma Limited