tegretol xr

Generic: carbamazepine

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tegretol xr
Generic Name carbamazepine
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0511
Product ID 0078-0511_2765f762-2f4e-4a2b-ac10-cf8149d9a38e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020234
Listing Expiration 2026-12-31
Marketing Start 1996-03-25

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 00780511
Hyphenated Format 0078-0511

Supplemental Identifiers

RxCUI
199378 308971 308972 308976 308979 402505 402506 866303 866305 866307
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 tegretol xr (source: ndc)
Generic Name carbamazepine (source: ndc)
Application Number NDA020234 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0511-05)
source: ndc

Packages (1)

0078-0511-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0511-05)

Ingredients (1)

carbamazepine (200 mg/1)

Linked Drug Pages (1)

Tegretol, Tegretol XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2765f762-2f4e-4a2b-ac10-cf8149d9a38e", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["199378", "308971", "308972", "308976", "308979", "402505", "402506", "866303", "866305", "866307"], "spl_set_id": ["8d409411-aa9f-4f3a-a52c-fbcb0c3ec053"], "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": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0511-05)", "package_ndc": "0078-0511-05", "marketing_start_date": "19960325"}], "brand_name": "Tegretol XR", "product_id": "0078-0511_2765f762-2f4e-4a2b-ac10-cf8149d9a38e", "dosage_form": "TABLET, EXTENDED RELEASE", "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": "0078-0511", "generic_name": "carbamazepine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tegretol", "brand_name_suffix": "XR", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "NDA020234", "marketing_category": "NDA", "marketing_start_date": "19960325", "listing_expiration_date": "20261231"}