carbamazepine

Generic: carbamazepine

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler torrent pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-268
Product ID 13668-268_2b305f64-7c1a-4cf6-a4ad-57326eb4c874
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077272
Listing Expiration 2026-12-31
Marketing Start 2009-10-23

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 13668268
Hyphenated Format 13668-268

Supplemental Identifiers

RxCUI
308973 308979
UPC
0313668268300
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 ANDA077272 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13668-268-01)
  • 500 TABLET in 1 BOTTLE (13668-268-05)
  • 1000 TABLET in 1 BOTTLE (13668-268-10)
  • 30 TABLET in 1 BOTTLE (13668-268-30)
  • 2500 TABLET in 1 BOTTLE (13668-268-31)
source: ndc

Packages (5)

13668-268-01 100 TABLET in 1 BOTTLE (13668-268-01) 13668-268-05 500 TABLET in 1 BOTTLE (13668-268-05) 13668-268-10 1000 TABLET in 1 BOTTLE (13668-268-10) 13668-268-30 30 TABLET in 1 BOTTLE (13668-268-30) 13668-268-31 2500 TABLET in 1 BOTTLE (13668-268-31)

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": "2b305f64-7c1a-4cf6-a4ad-57326eb4c874", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0313668268300"], "unii": ["33CM23913M"], "rxcui": ["308973", "308979"], "spl_set_id": ["97e6e175-75e8-437b-b457-ddb1ae4e857d"], "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": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13668-268-01)", "package_ndc": "13668-268-01", "marketing_start_date": "20091023"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-268-05)", "package_ndc": "13668-268-05", "marketing_start_date": "20091023"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13668-268-10)", "package_ndc": "13668-268-10", "marketing_start_date": "20091023"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13668-268-30)", "package_ndc": "13668-268-30", "marketing_start_date": "20091023"}, {"sample": false, "description": "2500 TABLET in 1 BOTTLE (13668-268-31)", "package_ndc": "13668-268-31", "marketing_start_date": "20091023"}], "brand_name": "CARBAMAZEPINE", "product_id": "13668-268_2b305f64-7c1a-4cf6-a4ad-57326eb4c874", "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": "13668-268", "generic_name": "CARBAMAZEPINE", "labeler_name": "Torrent Pharmaceuticals Limited", "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": "20091023", "listing_expiration_date": "20261231"}