carbamazepine

Generic: carbamazepine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler coupler llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbamazepine 300 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1455
Product ID 67046-1455_2d936849-9c55-5b7f-e063-6294a90aaa6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076697
Listing Expiration 2026-12-31
Marketing Start 2025-02-07

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 670461455
Hyphenated Format 67046-1455

Supplemental Identifiers

RxCUI
200131
UNII
33CM23913M
NUI
N0000008486 N0000175751 N0000185506 N0000191266 N0000187064 N0000185507 N0000185607

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 (source: ndc)
Generic Name carbamazepine (source: ndc)
Application Number ANDA076697 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1455-3)
source: ndc

Packages (1)

67046-1455-3 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1455-3)

Ingredients (1)

carbamazepine (300 mg/1)

Linked Drug Pages (1)

Carbamazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d936849-9c55-5b7f-e063-6294a90aaa6c", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["200131"], "spl_set_id": ["2d936849-9c80-5b7f-e063-6294a90aaa6c"], "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": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1455-3)", "package_ndc": "67046-1455-3", "marketing_start_date": "20250207"}], "brand_name": "Carbamazepine", "product_id": "67046-1455_2d936849-9c55-5b7f-e063-6294a90aaa6c", "dosage_form": "CAPSULE, 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": "67046-1455", "generic_name": "carbamazepine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA076697", "marketing_category": "ANDA", "marketing_start_date": "20250207", "listing_expiration_date": "20261231"}