equetro

Generic: carbamazepine

Labeler: validus pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name equetro
Generic Name carbamazepine
Labeler validus pharmaceuticals llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Validus Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 30698-421
Product ID 30698-421_3cbb63f0-feee-fc41-e063-6294a90a5d40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021710
Listing Expiration 2026-12-31
Marketing Start 2004-12-10

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 30698421
Hyphenated Format 30698-421

Supplemental Identifiers

RxCUI
200131 200133 388311 672908 672909 672910
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 equetro (source: ndc)
Generic Name carbamazepine (source: ndc)
Application Number NDA021710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-421-12)
source: ndc

Packages (1)

30698-421-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-421-12)

Ingredients (1)

carbamazepine (200 mg/1)

Linked Drug Pages (1)

EQUETRO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3cbb63f0-feee-fc41-e063-6294a90a5d40", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["200131", "200133", "388311", "672908", "672909", "672910"], "spl_set_id": ["be478f3c-40f6-47cc-8ab9-f420a9372b1c"], "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": ["Validus Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-421-12)", "package_ndc": "30698-421-12", "marketing_start_date": "20041210"}], "brand_name": "EQUETRO", "product_id": "30698-421_3cbb63f0-feee-fc41-e063-6294a90a5d40", "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": "30698-421", "generic_name": "Carbamazepine", "labeler_name": "Validus Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EQUETRO", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "NDA021710", "marketing_category": "NDA", "marketing_start_date": "20041210", "listing_expiration_date": "20261231"}