List of Excipients in API bedaquiline fumarate
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Excipients in NDA-approved (novel) drugs containing bedaquiline fumarate
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| Janssen Products LP | SIRTURO | bedaquiline fumarate | 59676-701 | CELLULOSE, MICROCRYSTALLINE | 2029-03-19 |
| Janssen Products LP | SIRTURO | bedaquiline fumarate | 59676-701 | CROSCARMELLOSE SODIUM | 2029-03-19 |
| Janssen Products LP | SIRTURO | bedaquiline fumarate | 59676-701 | HYPROMELLOSE 2910 | 2029-03-19 |
| Janssen Products LP | SIRTURO | bedaquiline fumarate | 59676-701 | LACTOSE MONOHYDRATE | 2029-03-19 |
| Janssen Products LP | SIRTURO | bedaquiline fumarate | 59676-701 | MAGNESIUM STEARATE | 2029-03-19 |
| Janssen Products LP | SIRTURO | bedaquiline fumarate | 59676-701 | POLYSORBATE 20 | 2029-03-19 |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Detailed excipient profiles for bedaquiline fumarate
Excipient focus: CELLULOSE, MICROCRYSTALLINE
bedaquiline fumarate drug variants containing CELLULOSE, MICROCRYSTALLINE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing CELLULOSE, MICROCRYSTALLINE
| Company | Ingredient | NDC |
|---|---|---|
| >Company | >Ingredient | >NDC |
Excipient focus: CROSCARMELLOSE SODIUM
bedaquiline fumarate drug variants containing CROSCARMELLOSE SODIUM
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing CROSCARMELLOSE SODIUM
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
Excipient focus: CROSPOVIDONE
bedaquiline fumarate drug variants containing CROSPOVIDONE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing CROSPOVIDONE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| >Company | >Ingredient | >NDC |
Excipient focus: HYPROMELLOSE 2910
bedaquiline fumarate drug variants containing HYPROMELLOSE 2910
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing HYPROMELLOSE 2910
| Company | Ingredient | NDC |
|---|---|---|
| >Company | >Ingredient | >NDC |
Excipient focus: LACTOSE MONOHYDRATE
bedaquiline fumarate drug variants containing LACTOSE MONOHYDRATE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing LACTOSE MONOHYDRATE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
Excipient focus: MAGNESIUM STEARATE
bedaquiline fumarate drug variants containing MAGNESIUM STEARATE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing MAGNESIUM STEARATE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
Excipient focus: POLYSORBATE 20
bedaquiline fumarate drug variants containing POLYSORBATE 20
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing POLYSORBATE 20
| Company | Ingredient | NDC |
|---|---|---|
| >Company | >Ingredient | >NDC |
Excipient focus: SILICON DIOXIDE
bedaquiline fumarate drug variants containing SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| >Company | >Ingredient | >NDC |
Excipient focus: SODIUM STEARYL FUMARATE
bedaquiline fumarate drug variants containing SODIUM STEARYL FUMARATE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing SODIUM STEARYL FUMARATE
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| >Company | >Ingredient | >NDC |
Excipient focus: STARCH, CORN
bedaquiline fumarate drug variants containing STARCH, CORN
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing STARCH, CORN
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
Excipient focus: WATER
bedaquiline fumarate drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Janssen Products LP | bedaquiline fumarate | 59676-701 |
| Janssen Products LP | bedaquiline fumarate | 59676-702 |
| >Company | >Ingredient | >NDC |
bedaquiline fumarate drug variants not containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| >Company | >Ingredient | >NDC |
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