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 TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbamazepine 400 mg/1

Manufacturer
Coupler, LLC

Identifiers & Regulatory

Product NDC 67046-1534
Product ID 67046-1534_30b755a0-6565-ebf3-e063-6294a90a07b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078115
Listing Expiration 2026-12-31
Marketing Start 2025-03-19

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 670461534
Hyphenated Format 67046-1534

Supplemental Identifiers

RxCUI
402506
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 ANDA078115 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1534-3)
source: ndc

Packages (1)

67046-1534-3 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1534-3)

Ingredients (1)

carbamazepine (400 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": "30b755a0-6565-ebf3-e063-6294a90a07b6", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["402506"], "spl_set_id": ["30b75584-3a1c-c125-e063-6294a90acaa7"], "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 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1534-3)", "package_ndc": "67046-1534-3", "marketing_start_date": "20250319"}], "brand_name": "Carbamazepine", "product_id": "67046-1534_30b755a0-6565-ebf3-e063-6294a90a07b6", "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": "67046-1534", "generic_name": "Carbamazepine", "labeler_name": "Coupler, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "400 mg/1"}], "application_number": "ANDA078115", "marketing_category": "ANDA", "marketing_start_date": "20250319", "listing_expiration_date": "20261231"}