KRISOSPB-8696- sodium phenylbutyrate granule 
Sri Krishna Pharmaceuticals Ltd. Unit I

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KRISOSPB-86.96

KRISOSPB-86.96

KRISOSPB-86.96

KRISOSPB-8696 
sodium phenylbutyrate granule
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:66326-207
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHENYLBUTYRATE (UNII: NT6K61736T) (PHENYLBUTYRIC ACID - UNII:7WY7YBI87E) SODIUM PHENYLBUTYRATE869.6 g  in 1 kg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 21.7 g  in 1 kg
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 69.6 g  in 1 kg
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) 17.4 g  in 1 kg
MAGNESIUM STEARATE (UNII: 70097M6I30) 21.7 g  in 1 kg
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66326-207-0225 kg in 1 DRUM12/31/2019
2NDC:66326-207-0110 kg in 1 DRUM12/31/2019
3NDC:66326-207-0340 kg in 1 DRUM12/31/2019
4NDC:66326-207-0450 kg in 1 DRUM12/31/2019
5NDC:66326-207-0575 kg in 1 DRUM12/31/2019
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only12/31/2019
Labeler - Sri Krishna Pharmaceuticals Ltd. Unit I (650633472)
Registrant - Sri Krishna Pharmaceuticals Ltd. Init I (650633472)
Establishment
NameAddressID/FEIBusiness Operations
Sri Krishna Pharmaceuticals Ltd. Unit II675981458api manufacture(66326-207)

Revised: 10/2023
Document Id: 080eba7f-24eb-437d-e063-6394a90a8f94
Set id: 25aeee69-6bfa-475c-a9ab-cd7f67fe2840
Version: 8
Effective Time: 20231019
 
Sri Krishna Pharmaceuticals Ltd. Unit I