carbamazepine er (35561-355)

Drug Facts

Product Profile

Brand Name carbamazepine er

Generic Name carbamazepine

Labeler bostal llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

carbamazepine 100 mg/1

Manufacturer

Bostal LLC

Identifiers & Regulatory

Product NDC 35561-355

Product ID 35561-355_4a5c74a0-6825-c4d6-e063-6294a90a65b6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215591

Listing Expiration 2027-12-31

Marketing Start 2022-03-31

Pharmacologic Class

Established (EPC)

mood stabilizer [epc]

Mechanism of Action

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]

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35561355

Hyphenated Format 35561-355

Supplemental Identifiers

RxCUI

199378 402505 402506

UPC

0335561357134 0335561356137 0335561355130

UNII

33CM23913M

NUI

N0000008486 N0000175751 N0000185506 N0000191266 N0000187064 N0000185507 N0000185607

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name carbamazepine er (source: ndc)

Generic Name carbamazepine (source: ndc)

Application Number ANDA215591 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/1

source: ndc

Packaging

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-13)

source: ndc

Packages (2)

35561-355-12 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12) 35561-355-13 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-13)

Ingredients (1)

carbamazepine (100 mg/1)

Linked Drug Pages (1)

CARBAMAZEPINE ER ndc-match (0.9)

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"}