NDC 71776-035

TobraDex ST

Tobramycin / Dexamethasone

TobraDex ST is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Eyevance Pharmaceuticals Llc. The primary component is Tobramycin; Dexamethasone.

Product ID71776-035_c2d733af-5b78-be2c-e053-2a95a90ac039
NDC71776-035
Product TypeHuman Prescription Drug
Proprietary NameTobraDex ST
Generic NameTobramycin / Dexamethasone
Dosage FormSuspension/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2021-05-19
Marketing CategoryNDA /
Application NumberNDA050818
Labeler NameEyevance Pharmaceuticals LLC
Substance NameTOBRAMYCIN; DEXAMETHASONE
Active Ingredient Strength3 mg/mL; mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71776-035-05

1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2021-05-19
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "TobraDex ST" or generic name "Tobramycin / Dexamethasone"

NDCBrand NameGeneric Name
0065-0652TOBRADEX STtobramycin / dexamethasone
71776-035TobraDex STtobramycin / dexamethasone

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