"53002-0523-3" National Drug Code (NDC)

Cyclobenzaprine Hydrochloride 15 TABLET, FILM COATED in 1 BOTTLE (53002-0523-3)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-0523-3
Package Description15 TABLET, FILM COATED in 1 BOTTLE (53002-0523-3)
Product NDC53002-0523
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameCyclobenzaprine Hydrochloride
Non-Proprietary NameCyclobenzaprine Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20200706
Marketing Category NameANDA
Application NumberANDA213324
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameCYCLOBENZAPRINE HYDROCHLORIDE
Strength5
Strength Unitmg/1
Pharmacy ClassesCentrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]

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