carbamazepine

Generic: carbamazepine

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-1396
Product ID 55154-1396_135e6ea0-11cb-437b-bf28-c926dc9b4496
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077272
Listing Expiration 2027-12-31
Marketing Start 2010-09-20

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 551541396
Hyphenated Format 55154-1396

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 ANDA077272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-1396-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-1396-0 10 BLISTER PACK in 1 BAG (55154-1396-0) / 1 TABLET in 1 BLISTER PACK

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": "135e6ea0-11cb-437b-bf28-c926dc9b4496", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["308979"], "spl_set_id": ["232ef732-ee6d-4ac7-8e78-c619b611fbbe"], "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": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-1396-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-1396-0", "marketing_start_date": "20100920"}], "brand_name": "Carbamazepine", "product_id": "55154-1396_135e6ea0-11cb-437b-bf28-c926dc9b4496", "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": "55154-1396", "generic_name": "Carbamazepine", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "ANDA077272", "marketing_category": "ANDA", "marketing_start_date": "20100920", "listing_expiration_date": "20271231"}