KRISOSPB-8696- sodium phenylbutyrate granule

KRISOSPB-8696 by

Drug Labeling and Warnings

KRISOSPB-8696 by is a Other medication manufactured, distributed, or labeled by Sri Krishna Pharmaceuticals Ltd. Unit I, Sri Krishna Pharmaceuticals Ltd. Init I, Sri Krishna Pharmaceuticals Ltd. Unit II. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KRISOSPB-86.96

INGREDIENTS AND APPEARANCE

KRISOSPB-8696 
sodium phenylbutyrate granule

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 66326-207
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHENYLBUTYRATE (UNII: NT6K61736T) (PHENYLBUTYRIC ACID - UNII:7WY7YBI87E)	SODIUM PHENYLBUTYRATE	869.6 g  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66326-207-02	25 kg in 1 DRUM	12/31/2019
2	NDC: 66326-207-01	10 kg in 1 DRUM	12/31/2019
3	NDC: 66326-207-03	40 kg in 1 DRUM	12/31/2019
4	NDC: 66326-207-04	50 kg in 1 DRUM	12/31/2019
5	NDC: 66326-207-05	75 kg in 1 DRUM	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		12/31/2019

Labeler - Sri Krishna Pharmaceuticals Ltd. Unit I (650633472)

Registrant - Sri Krishna Pharmaceuticals Ltd. Init I (650633472)

Establishment
Name	Address	ID/FEI	Business Operations
Sri Krishna Pharmaceuticals Ltd. Unit II		675981458	api manufacture(66326-207)