carbamazepine

Generic: carbamazepine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0183
Product ID 60505-0183_e6a60bd5-3bd4-783c-7fb0-25fee964d387
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075948
Listing Expiration 2026-12-31
Marketing Start 2002-09-01

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 605050183
Hyphenated Format 60505-0183

Supplemental Identifiers

RxCUI
308979
UPC
0360505018307
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 ANDA075948 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (60505-0183-0)
  • 1000 TABLET in 1 BOTTLE (60505-0183-1)
source: ndc

Packages (2)

60505-0183-0 100 TABLET in 1 BOTTLE (60505-0183-0) 60505-0183-1 1000 TABLET in 1 BOTTLE (60505-0183-1)

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": "e6a60bd5-3bd4-783c-7fb0-25fee964d387", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0360505018307"], "unii": ["33CM23913M"], "rxcui": ["308979"], "spl_set_id": ["bf0d012f-da14-8ce3-d74f-56172cddebc5"], "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": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (60505-0183-0)", "package_ndc": "60505-0183-0", "marketing_start_date": "20020901"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (60505-0183-1)", "package_ndc": "60505-0183-1", "marketing_start_date": "20020901"}], "brand_name": "CARBAMAZEPINE", "product_id": "60505-0183_e6a60bd5-3bd4-783c-7fb0-25fee964d387", "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": "60505-0183", "generic_name": "CARBAMAZEPINE", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CARBAMAZEPINE", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "ANDA075948", "marketing_category": "ANDA", "marketing_start_date": "20020901", "listing_expiration_date": "20261231"}