Package 35561-355-13

Brand: carbamazepine er

Generic: carbamazepine
NDC Package

Package Facts

Identity

Package NDC 35561-355-13
Digits Only 3556135513
Product NDC 35561-355
Description

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-13)

Marketing

Marketing Status
Marketed Since 2025-03-31
Brand carbamazepine er
Generic carbamazepine
Sample Package No

Linked Drug Pages (0)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4a5c74a0-6825-c4d6-e063-6294a90a65b6", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0335561357134", "0335561356137", "0335561355130"], "unii": ["33CM23913M"], "rxcui": ["199378", "402505", "402506"], "spl_set_id": ["b48741b3-0889-47b8-a26e-b12614f6e7fc"], "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": ["Bostal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12)", "package_ndc": "35561-355-12", "marketing_start_date": "20220331"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-13)", "package_ndc": "35561-355-13", "marketing_start_date": "20250331"}], "brand_name": "CARBAMAZEPINE ER", "product_id": "35561-355_4a5c74a0-6825-c4d6-e063-6294a90a65b6", "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": "35561-355", "generic_name": "carbamazepine", "labeler_name": "Bostal LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CARBAMAZEPINE ER", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/1"}], "application_number": "ANDA215591", "marketing_category": "ANDA", "marketing_start_date": "20220331", "listing_expiration_date": "20271231"}