Package 0078-0510-05

Brand: tegretol xr

Generic: carbamazepine
NDC Package

Package Facts

Identity

Package NDC 0078-0510-05
Digits Only 0078051005
Product NDC 0078-0510
Description

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0510-05)

Marketing

Marketing Status
Marketed Since 1996-03-25
Brand tegretol xr
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, EXTENDED RELEASE in 1 BOTTLE (0078-0510-05)", "package_ndc": "0078-0510-05", "marketing_start_date": "19960325"}], "brand_name": "Tegretol XR", "product_id": "0078-0510_2765f762-2f4e-4a2b-ac10-cf8149d9a38e", "dosage_form": "TABLET, EXTENDED RELEASE", "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": "0078-0510", "generic_name": "carbamazepine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tegretol", "brand_name_suffix": "XR", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/1"}], "application_number": "NDA020234", "marketing_category": "NDA", "marketing_start_date": "19960325", "listing_expiration_date": "20261231"}