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INFASURF
INFASURF - 61938-456-03 - (CALFACTANT)
Drug Information of INFASURF
| Product NDC: | 61938-456 |
| Proprietary Name: | INFASURF |
| Non Proprietary Name: | CALFACTANT |
| Active Ingredient(s): | 35.7 mg/mL & nbsp; CALFACTANT |
| Administration Route(s): | ENDOTRACHEAL |
| Dosage Form(s): | SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of INFASURF
| Product NDC: | 61938-456 |
| Labeler Name: | Ony, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020521 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110721 |
Package Information of INFASURF
| Package NDC: | 61938-456-03 |
| Package Description: | 1 VIAL, GLASS in 1 CARTON (61938-456-03) > 3 mL in 1 VIAL, GLASS |
NDC Information of INFASURF
| NDC Code | 61938-456-03 |
| Proprietary Name | INFASURF |
| Package Description | 1 VIAL, GLASS in 1 CARTON (61938-456-03) > 3 mL in 1 VIAL, GLASS |
| Product NDC | 61938-456 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | CALFACTANT |
| Dosage Form Name | SUSPENSION |
| Route Name | ENDOTRACHEAL |
| Start Marketing Date | 20110721 |
| Marketing Category Name | NDA |
| Labeler Name | Ony, Inc. |
| Substance Name | CALFACTANT |
| Strength Number | 35.7 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] |
