Drug Labeling and Warnings

Drug Details [pdf]

SUMATRIPTAN - sumatriptan succinate tablet 
Aurobindo Pharma Limited

----------

 

Sumatriptan Succinate Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg Bulk Tablet Label


10000 Tablets

Batch      :

Mfg        :

Expiry     :

To be repacked within six months from the date of manufacturing

NDC: 65862-146-19

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Sumatriptan Succinate Tablets 25 mg*

*Each tablet contains: Sumatriptan succinate equivalent to 25 mg of sumatriptan.

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 - 25 mg Bulk Tablet Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg Bulk Tablet Label



2500 Tablets

Batch      :

Mfg        :

Expiry     :

To be repacked within six months from the date of manufacturing

NDC: 65862-147-26

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Sumatriptan Succinate Tablets 50 mg*

*Each tablet contains: Sumatriptan succinate equivalent to 50 mg of sumatriptan.

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 - 50 mg Bulk Tablet Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg Bulk Tablet Label



2000 Tablets

Batch      :

Mfg        :

Expiry     :

To be repacked within six months from the date of manufacturing

NDC: 65862-148-22

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Sumatriptan Succinate Tablets 100 mg*

*Each tablet contains: Sumatriptan succinate equivalent to 100 mg of sumatriptan.

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 - 100 mg Bulk Tablet Label
SUMATRIPTAN 
sumatriptan succinate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-146
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorWHITE (White to off-white) Scoreno score
ShapeROUND (biconvex) Size6mm
FlavorImprint Code C;32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65862-146-1910000 in 1 BAG; Type 0: Not a Combination Product08/17/200910/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07832708/17/200910/28/2019
SUMATRIPTAN 
sumatriptan succinate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-147
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorWHITE (White to off-white) Scoreno score
ShapeCAPSULE (biconvex) Size11mm
FlavorImprint Code C;33
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65862-147-262500 in 1 BAG; Type 0: Not a Combination Product08/17/200910/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07832708/17/200910/28/2019
SUMATRIPTAN 
sumatriptan succinate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-148
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN100 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorWHITE (White to off-white) Scoreno score
ShapeCAPSULE (biconvex) Size12mm
FlavorImprint Code C;34
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65862-148-222000 in 1 BAG; Type 0: Not a Combination Product08/17/200910/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07832708/17/200910/28/2019
Labeler - Aurobindo Pharma Limited (650082092)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(65862-146, 65862-147, 65862-148) , MANUFACTURE(65862-146, 65862-147, 65862-148)

Revised: 10/2019
Document Id: bbc01f38-1afd-4b78-bf70-bf7a3fbdff68
Set id: 57510ffd-33cc-4532-bc2a-877a784b015c
Version: 3
Effective Time: 20191028
 
Aurobindo Pharma Limited