carbamazepine

Generic: carbamazepine

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

carbamazepine 100 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8125
Product ID 0615-8125_f8c0c630-dec1-4c2b-9925-39f6a3c86909
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075687
Listing Expiration 2026-12-31
Marketing Start 2000-10-24

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 06158125
Hyphenated Format 0615-8125

Supplemental Identifiers

RxCUI
308973
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 ANDA075687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39)
source: ndc

Packages (1)

0615-8125-39 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39)

Ingredients (1)

carbamazepine (100 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": "f8c0c630-dec1-4c2b-9925-39f6a3c86909", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["308973"], "spl_set_id": ["963db7cf-e9f5-496c-816e-626e89bc839e"], "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": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39)", "package_ndc": "0615-8125-39", "marketing_start_date": "20190606"}], "brand_name": "Carbamazepine", "product_id": "0615-8125_f8c0c630-dec1-4c2b-9925-39f6a3c86909", "dosage_form": "TABLET, CHEWABLE", "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": "0615-8125", "generic_name": "Carbamazepine", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/1"}], "application_number": "ANDA075687", "marketing_category": "ANDA", "marketing_start_date": "20001024", "listing_expiration_date": "20261231"}