clobazam

Generic: clobazam

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

clobazam 2.5 mg/mL

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-4227
Product ID 51672-4227_1fd3064f-ed73-9de1-e063-6294a90a0d97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210978
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-06-30

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 516724227
Hyphenated Format 51672-4227

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 ANDA210978 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (51672-4227-8)
source: ndc

Packages (1)

51672-4227-8 120 mL in 1 BOTTLE (51672-4227-8)

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": "1fd3064f-ed73-9de1-e063-6294a90a0d97", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "unii": ["2MRO291B4U"], "rxcui": ["1366192"], "spl_set_id": ["fd1e63bf-496c-427c-83b7-6acabc00a5e5"], "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": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (51672-4227-8)", "package_ndc": "51672-4227-8", "marketing_start_date": "20210630"}], "brand_name": "Clobazam", "product_id": "51672-4227_1fd3064f-ed73-9de1-e063-6294a90a0d97", "dosage_form": "SUSPENSION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "51672-4227", "dea_schedule": "CIV", "generic_name": "clobazam", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "2.5 mg/mL"}], "application_number": "ANDA210978", "marketing_category": "ANDA", "marketing_start_date": "20210630", "listing_expiration_date": "20261231"}