clobazam

Generic: clobazam

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler aurobindo pharma limited
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

clobazam 2.5 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-401
Product ID 59651-401_df4d6b4b-9864-4c24-92e1-4a72c2863b5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214404
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2022-03-24

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Mechanism of Action
cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inducers [moa]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651401
Hyphenated Format 59651-401

Supplemental Identifiers

RxCUI
1366192
UNII
2MRO291B4U
NUI
N0000175694 M0002356 N0000182137 N0000185506

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 clobazam (source: ndc)
Generic Name clobazam (source: ndc)
Application Number ANDA214404 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-401-12) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

59651-401-12 1 BOTTLE in 1 CARTON (59651-401-12) / 120 mL in 1 BOTTLE

Ingredients (1)

clobazam (2.5 mg/mL)

Linked Drug Pages (1)

Clobazam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "df4d6b4b-9864-4c24-92e1-4a72c2863b5f", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "unii": ["2MRO291B4U"], "rxcui": ["1366192"], "spl_set_id": ["1b5749a1-1c6d-4243-a833-4bfd84f9d5a9"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "pharm_class_moa": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-401-12)  / 120 mL in 1 BOTTLE", "package_ndc": "59651-401-12", "marketing_start_date": "20220324"}], "brand_name": "Clobazam", "product_id": "59651-401_df4d6b4b-9864-4c24-92e1-4a72c2863b5f", "dosage_form": "SUSPENSION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "59651-401", "dea_schedule": "CIV", "generic_name": "Clobazam", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "2.5 mg/mL"}], "application_number": "ANDA214404", "marketing_category": "ANDA", "marketing_start_date": "20220324", "listing_expiration_date": "20261231"}