carbatrol

Generic: carbamazepine

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbatrol
Generic Name carbamazepine
Labeler takeda pharmaceuticals america, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbamazepine 100 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-171
Product ID 54092-171_39171a32-c78d-4130-be53-638e19cf2261
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020712
Listing Expiration 2026-12-31
Marketing Start 1999-12-22

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 54092171
Hyphenated Format 54092-171

Supplemental Identifiers

RxCUI
200131 200133 308977 313931 388311 404742
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 carbatrol (source: ndc)
Generic Name carbamazepine (source: ndc)
Application Number NDA020712 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12)
source: ndc

Packages (1)

54092-171-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12)

Ingredients (1)

carbamazepine (100 mg/1)

Linked Drug Pages (1)

Carbatrol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39171a32-c78d-4130-be53-638e19cf2261", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["200131", "200133", "308977", "313931", "388311", "404742"], "spl_set_id": ["bc03e499-5bac-4293-bff4-6864153a624d"], "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": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12)", "package_ndc": "54092-171-12", "marketing_start_date": "19991222"}], "brand_name": "Carbatrol", "product_id": "54092-171_39171a32-c78d-4130-be53-638e19cf2261", "dosage_form": "CAPSULE, 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": "54092-171", "generic_name": "carbamazepine", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbatrol", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/1"}], "application_number": "NDA020712", "marketing_category": "NDA", "marketing_start_date": "19991222", "listing_expiration_date": "20261231"}