"0121-0927-16" National Drug Code (NDC)

Promethazine Hydrochloride 473 mL in 1 BOTTLE (0121-0927-16)
(PAI Holdings, LLC)

NDC Code0121-0927-16
Package Description473 mL in 1 BOTTLE (0121-0927-16)
Product NDC0121-0927
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePromethazine Hydrochloride
Non-Proprietary NamePromethazine Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20200918
Marketing Category NameANDA
Application NumberANDA040643
ManufacturerPAI Holdings, LLC
Substance NamePROMETHAZINE HYDROCHLORIDE
Strength6.25
Strength Unitmg/5mL
Pharmacy ClassesPhenothiazine [EPC], Phenothiazines [CS]

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