Package 53451-0101-1
Brand: horizant
Generic: gabapentin enacarbilPackage Facts
Identity
Package NDC
53451-0101-1
Digits Only
5345101011
Product NDC
53451-0101
Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)
Marketing
Marketing Status
Brand
horizant
Generic
gabapentin enacarbil
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "33da187f-72d1-daa5-e063-6394a90a66b1", "openfda": {"unii": ["75OCL1SPBQ"], "rxcui": ["1101338", "1101339", "1482820", "1482821"], "spl_set_id": ["4c486fc7-c8c4-4c6c-b30c-366dabaeaadd"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)", "package_ndc": "53451-0101-1", "marketing_start_date": "20130501"}, {"sample": false, "description": "5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-9)", "package_ndc": "53451-0101-9", "marketing_start_date": "20130501"}], "brand_name": "Horizant", "product_id": "53451-0101_33da187f-72d1-daa5-e063-6394a90a66b1", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "53451-0101", "generic_name": "gabapentin enacarbil", "labeler_name": "Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Horizant", "active_ingredients": [{"name": "GABAPENTIN ENACARBIL", "strength": "600 mg/1"}], "application_number": "NDA022399", "marketing_category": "NDA", "marketing_start_date": "20130501", "listing_expiration_date": "20261231"}