Package 46708-422-91

Brand: carbamazepine

Generic: carbamazepine
NDC Package

Package Facts

Identity

Package NDC 46708-422-91
Digits Only 4670842291
Product NDC 46708-422
Description

1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-422-91)

Marketing

Marketing Status
Marketed Since 2025-07-26
Brand carbamazepine
Generic carbamazepine
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1fc170d7-db1a-486d-8c10-faa6e3da3b1e", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0346708420314", "0346708421311", "0346708422318"], "unii": ["33CM23913M"], "rxcui": ["199378", "402505", "402506"], "spl_set_id": ["1fc170d7-db1a-486d-8c10-faa6e3da3b1e"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-422-31)", "package_ndc": "46708-422-31", "marketing_start_date": "20250726"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-422-91)", "package_ndc": "46708-422-91", "marketing_start_date": "20250726"}], "brand_name": "Carbamazepine", "product_id": "46708-422_1fc170d7-db1a-486d-8c10-faa6e3da3b1e", "dosage_form": "TABLET, FILM COATED, 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": "46708-422", "generic_name": "Carbamazepine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "400 mg/1"}], "application_number": "ANDA219939", "marketing_category": "ANDA", "marketing_start_date": "20250726", "listing_expiration_date": "20261231"}