carbamazepine

Generic: carbamazepine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-953
Product ID 43353-953_7c7b8491-2291-48de-8b76-bf2eca6c9d9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075948
Listing Expiration 2026-12-31
Marketing Start 2014-03-07

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 43353953
Hyphenated Format 43353-953

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (43353-953-53)
  • 90 TABLET in 1 BOTTLE (43353-953-60)
  • 180 TABLET in 1 BOTTLE (43353-953-80)
source: ndc

Packages (3)

43353-953-53 60 TABLET in 1 BOTTLE (43353-953-53) 43353-953-60 90 TABLET in 1 BOTTLE (43353-953-60) 43353-953-80 180 TABLET in 1 BOTTLE (43353-953-80)

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": "7c7b8491-2291-48de-8b76-bf2eca6c9d9c", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["308979"], "spl_set_id": ["c1fc31ef-6b2e-4de4-a185-ec44e94e7b40"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-953-53)", "package_ndc": "43353-953-53", "marketing_start_date": "20140703"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-953-60)", "package_ndc": "43353-953-60", "marketing_start_date": "20140703"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (43353-953-80)", "package_ndc": "43353-953-80", "marketing_start_date": "20140725"}], "brand_name": "CARBAMAZEPINE", "product_id": "43353-953_7c7b8491-2291-48de-8b76-bf2eca6c9d9c", "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": "43353-953", "generic_name": "CARBAMAZEPINE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "20140307", "listing_expiration_date": "20261231"}