carbamazepine

Generic: carbamazepine

Labeler: umedica laboratories usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler umedica laboratories usa inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbamazepine 400 mg/1

Manufacturer
Umedica Laboratories USA Inc.

Identifiers & Regulatory

Product NDC 60290-060
Product ID 60290-060_482c3fad-fac0-fa00-e063-6394a90a4b75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216594
Listing Expiration 2027-12-31
Marketing Start 2022-08-20

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 60290060
Hyphenated Format 60290-060

Supplemental Identifiers

RxCUI
199378 402505 402506
UPC
0360290059011 0360290060017 0360290058014
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 ANDA216594 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-060-01)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-060-02)
source: ndc

Packages (2)

60290-060-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-060-01) 60290-060-02 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-060-02)

Ingredients (1)

carbamazepine (400 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": "482c3fad-fac0-fa00-e063-6394a90a4b75", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0360290059011", "0360290060017", "0360290058014"], "unii": ["33CM23913M"], "rxcui": ["199378", "402505", "402506"], "spl_set_id": ["48080efd-1781-4585-83f8-c43957ac63b3"], "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": ["Umedica Laboratories USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-060-01)", "package_ndc": "60290-060-01", "marketing_start_date": "20220820"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-060-02)", "package_ndc": "60290-060-02", "marketing_start_date": "20220820"}], "brand_name": "Carbamazepine", "product_id": "60290-060_482c3fad-fac0-fa00-e063-6394a90a4b75", "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": "60290-060", "generic_name": "Carbamazepine", "labeler_name": "Umedica Laboratories USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "400 mg/1"}], "application_number": "ANDA216594", "marketing_category": "ANDA", "marketing_start_date": "20220820", "listing_expiration_date": "20271231"}