Label: KRISOSPB-8696- sodium phenylbutyrate granule
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NDC Code(s):
66326-207-01,
66326-207-02,
66326-207-03,
66326-207-04, view more66326-207-05
- Packager: Sri Krishna Pharmaceuticals Ltd. Unit I
- Category: BULK INGREDIENT
Drug Label Information
Updated October 19, 2023
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- Official Label (Printer Friendly)
- KRISOSPB-86.96
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INGREDIENTS AND APPEARANCE
KRISOSPB-8696
sodium phenylbutyrate granuleProduct 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)
