KRISOSPB-8696- sodium phenylbutyrate granule
Sri Krishna Pharmaceuticals Ltd. Unit I
----------
KRISOSPB-86.96
KRISOSPB-86.96

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 |
| CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) | 69.6 g in 1 kg |
| SILICON DIOXIDE (UNII: ETJ7Z6XBU4) | 21.7 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 | 12/15/2025 |
| 2 | NDC: 66326-207-01 | 10 kg in 1 DRUM | 12/31/2019 | 12/15/2025 |
| 3 | NDC: 66326-207-03 | 40 kg in 1 DRUM | 12/31/2019 | 12/15/2025 |
| 4 | NDC: 66326-207-04 | 50 kg in 1 DRUM | 12/31/2019 | 12/15/2025 |
| 5 | NDC: 66326-207-05 | 75 kg in 1 DRUM | 12/31/2019 | 12/15/2025 |
|
 |
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Export only | | 12/31/2019 | 12/15/2025 |
|
| 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) |
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