"82919-626-16" National Drug Code (NDC)

Ontralfy 473 mL in 1 BOTTLE, PLASTIC (82919-626-16)
(Fidelity BioPharma Co.)

NDC Code82919-626-16
Package Description473 mL in 1 BOTTLE, PLASTIC (82919-626-16)
Product NDC82919-626
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOntralfy
Non-Proprietary NameTizanidine Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20250331
Marketing Category NameNDA
Application NumberNDA216190
ManufacturerFidelity BioPharma Co.
Substance NameTIZANIDINE HYDROCHLORIDE
Strength2
Strength Unitmg/5mL
Pharmacy ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]

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