carbamazepine

Generic: carbamazepine

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-0109
Product ID 0093-0109_042aa2c6-95ff-410a-abcf-a8ee79fa96d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070541
Marketing Start 1990-09-30
Marketing End 2026-07-31

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 00930109
Hyphenated Format 0093-0109

Supplemental Identifiers

RxCUI
308973 308979
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 (source: ndc)
Generic Name carbamazepine (source: ndc)
Application Number ANDA070541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0093-0109-01)
  • 1000 TABLET in 1 BOTTLE (0093-0109-10)
source: ndc

Packages (2)

0093-0109-01 100 TABLET in 1 BOTTLE (0093-0109-01) 0093-0109-10 1000 TABLET in 1 BOTTLE (0093-0109-10)

Ingredients (1)

carbamazepine (200 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": "042aa2c6-95ff-410a-abcf-a8ee79fa96d8", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["308973", "308979"], "spl_set_id": ["bfd63965-56e6-4af7-b7ef-45a5105d4d35"], "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": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0093-0109-01)", "package_ndc": "0093-0109-01", "marketing_end_date": "20260630", "marketing_start_date": "19900930"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0093-0109-10)", "package_ndc": "0093-0109-10", "marketing_end_date": "20260731", "marketing_start_date": "19900930"}], "brand_name": "Carbamazepine", "product_id": "0093-0109_042aa2c6-95ff-410a-abcf-a8ee79fa96d8", "dosage_form": "TABLET", "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": "0093-0109", "generic_name": "Carbamazepine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "ANDA070541", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "19900930"}