Package 63443-5057-1
Brand: nicotine polacrilex gum
Generic: nicotine polacrilexPackage Facts
Identity
Package NDC
63443-5057-1
Digits Only
6344350571
Product NDC
63443-5057
Description
10 BLISTER PACK in 1 CARTON (63443-5057-1) / 10 GUM, CHEWING in 1 BLISTER PACK
Marketing
Marketing Status
Brand
nicotine polacrilex gum
Generic
nicotine polacrilex
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["BUCCAL"], "spl_id": "4b1e2904-b22d-4cb9-e063-6294a90a532c", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["f1774540-7c2f-c60b-e053-2995a90a1ccb"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Fertin Pharma A/S"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (63443-5057-1) / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "63443-5057-1", "marketing_start_date": "20221221"}], "brand_name": "Nicotine Polacrilex Gum", "product_id": "63443-5057_4b1e2904-b22d-4cb9-e063-6294a90a532c", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "63443-5057", "generic_name": "Nicotine Polacrilex", "labeler_name": "Fertin Pharma A/S", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex Gum", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA214354", "marketing_category": "ANDA", "marketing_start_date": "20221221", "listing_expiration_date": "20271231"}