carbamazepine

Generic: carbamazepine

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbamazepine 100 mg/1

Manufacturer
NIVAGEN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 75834-220
Product ID 75834-220_45806c19-4811-987e-e063-6394a90aa8fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207798
Listing Expiration 2026-12-31
Marketing Start 2020-04-21

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 75834220
Hyphenated Format 75834-220

Supplemental Identifiers

RxCUI
197441 308979
UPC
0375834220017 0375834221014 0375834220000 0375834221007
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 ANDA207798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (75834-220-00)
  • 100 TABLET in 1 BOTTLE (75834-220-01)
source: ndc

Packages (2)

75834-220-00 1000 TABLET in 1 BOTTLE (75834-220-00) 75834-220-01 100 TABLET in 1 BOTTLE (75834-220-01)

Ingredients (1)

carbamazepine (100 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": "45806c19-4811-987e-e063-6394a90aa8fa", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0375834220017", "0375834221014", "0375834220000", "0375834221007"], "unii": ["33CM23913M"], "rxcui": ["197441", "308979"], "spl_set_id": ["e68998cb-5f91-4d7e-85a6-555efb8b0384"], "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": ["NIVAGEN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (75834-220-00)", "package_ndc": "75834-220-00", "marketing_start_date": "20200421"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-220-01)", "package_ndc": "75834-220-01", "marketing_start_date": "20200421"}], "brand_name": "Carbamazepine", "product_id": "75834-220_45806c19-4811-987e-e063-6394a90aa8fa", "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": "75834-220", "generic_name": "Carbamazepine", "labeler_name": "NIVAGEN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/1"}], "application_number": "ANDA207798", "marketing_category": "ANDA", "marketing_start_date": "20200421", "listing_expiration_date": "20261231"}