"63443-5057-1" National Drug Code (NDC)

Nicotine Polacrilex Gum 10 BLISTER PACK in 1 CARTON (63443-5057-1) > 10 GUM, CHEWING in 1 BLISTER PACK
(Fertin Pharma A/S)

NDC Code63443-5057-1
Package Description10 BLISTER PACK in 1 CARTON (63443-5057-1) > 10 GUM, CHEWING in 1 BLISTER PACK
Product NDC63443-5057
Product Type NameHUMAN OTC DRUG
Proprietary NameNicotine Polacrilex Gum
Non-Proprietary NameNicotine Polacrilex
Dosage FormGUM, CHEWING
UsageBUCCAL
Start Marketing Date20221221
Marketing Category NameANDA
Application NumberANDA214354
ManufacturerFertin Pharma A/S
Substance NameNICOTINE
Strength4
Strength Unitmg/1
Pharmacy ClassesCholinergic Nicotinic Agonist [EPC], Nicotine [CS]

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