Package 0078-0509-05
Brand: tegretol
Generic: carbamazepinePackage Facts
Identity
Package NDC
0078-0509-05
Digits Only
0078050905
Product NDC
0078-0509
Description
100 TABLET in 1 BOTTLE (0078-0509-05)
Marketing
Marketing Status
Brand
tegretol
Generic
carbamazepine
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2765f762-2f4e-4a2b-ac10-cf8149d9a38e", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["199378", "308971", "308972", "308976", "308979", "402505", "402506", "866303", "866305", "866307"], "spl_set_id": ["8d409411-aa9f-4f3a-a52c-fbcb0c3ec053"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Mood Stabilizer [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0078-0509-05)", "package_ndc": "0078-0509-05", "marketing_start_date": "19680311"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (0078-0509-20)", "package_ndc": "0078-0509-20", "marketing_start_date": "20170406"}], "brand_name": "Tegretol", "product_id": "0078-0509_2765f762-2f4e-4a2b-ac10-cf8149d9a38e", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "0078-0509", "generic_name": "carbamazepine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tegretol", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "NDA016608", "marketing_category": "NDA", "marketing_start_date": "19680311", "listing_expiration_date": "20261231"}