"53002-1803-1" National Drug Code (NDC)

Azelastine Hydrochloride 1 BOTTLE, PLASTIC in 1 CARTON (53002-1803-1) / 6 mL in 1 BOTTLE, PLASTIC
(RPK Pharmaceuticals, Inc.)

NDC Code53002-1803-1
Package Description1 BOTTLE, PLASTIC in 1 CARTON (53002-1803-1) / 6 mL in 1 BOTTLE, PLASTIC
Product NDC53002-1803
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAzelastine Hydrochloride
Non-Proprietary NameAzelastine Hydrochloride
Dosage FormSOLUTION/ DROPS
UsageINTRAOCULAR
Start Marketing Date20130321
Marketing Category NameANDA
Application NumberANDA202305
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameAZELASTINE HYDROCHLORIDE
Strength.5
Strength Unitmg/mL
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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