"68628-500-31" National Drug Code (NDC)

Surfaxin 1 VIAL, SINGLE-USE in 1 CARTON (68628-500-31) > 8.5 mL in 1 VIAL, SINGLE-USE
(Discovery Laboratories, Inc.)

NDC Code68628-500-31
Package Description1 VIAL, SINGLE-USE in 1 CARTON (68628-500-31) > 8.5 mL in 1 VIAL, SINGLE-USE
Product NDC68628-500
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSurfaxin
Non-Proprietary NameLucinactant
Dosage FormSUSPENSION
UsageENDOTRACHEAL
Start Marketing Date20131101
Marketing Category NameNDA
Application NumberNDA021746
ManufacturerDiscovery Laboratories, Inc.
Substance NameCOLFOSCERIL PALMITATE; 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)), SODIUM SALT; PALMITIC ACID; SINAPULTIDE
Strength22.5; 7.5; 4.05; .862
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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