"69528-310-16" National Drug Code (NDC)

Ontralfy 473 mL in 1 BOTTLE, PLASTIC (69528-310-16)
(Rosemont Pharmaceuticals, LLC)

NDC Code69528-310-16
Package Description473 mL in 1 BOTTLE, PLASTIC (69528-310-16)
Product NDC69528-310
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOntralfy
Non-Proprietary NameTizanidine Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20250331
Marketing Category NameNDA
Application NumberNDA216190
ManufacturerRosemont Pharmaceuticals, LLC
Substance NameTIZANIDINE HYDROCHLORIDE
Strength2
Strength Unitmg/5mL
Pharmacy ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]

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