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"68083-657-10" National Drug Code (NDC)

Dexmedetomidine Hydrochloride 10 POUCH in 1 CARTON (68083-657-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
(Gland Pharma Limited)

NDC Code68083-657-10
Package Description10 POUCH in 1 CARTON (68083-657-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
Product NDC68083-657
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDexmedetomidine Hydrochloride
Non-Proprietary NameDexmedetomidine Hydrochloride
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20241219
Marketing Category NameANDA
Application NumberANDA209307
ManufacturerGland Pharma Limited
Substance NameDEXMEDETOMIDINE HYDROCHLORIDE
Strength4
Strength Unitug/mL
Pharmacy ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]

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