clobazam

Generic: clobazam

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler precision dose, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

clobazam 2.5 mg/mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-074
Product ID 68094-074_53326439-6544-44fa-b13c-6ea7517f4187
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210039
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-03-10

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 68094074
Hyphenated Format 68094-074

Supplemental Identifiers

RxCUI
1366192
UNII
2MRO291B4U
NUI
N0000175694 M0002356 N0000182137 N0000185506

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 ANDA210039 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 50 BAG in 1 CASE (68094-074-58) / 1 SYRINGE, PLASTIC in 1 BAG (68094-074-01) / 4 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

68094-074-58 50 BAG in 1 CASE (68094-074-58) / 1 SYRINGE, PLASTIC in 1 BAG (68094-074-01) / 4 mL in 1 SYRINGE, PLASTIC

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": "53326439-6544-44fa-b13c-6ea7517f4187", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "unii": ["2MRO291B4U"], "rxcui": ["1366192"], "spl_set_id": ["6332e71c-3b37-422c-838c-8a2489ac6009"], "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": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "50 BAG in 1 CASE (68094-074-58)  / 1 SYRINGE, PLASTIC in 1 BAG (68094-074-01)  / 4 mL in 1 SYRINGE, PLASTIC", "package_ndc": "68094-074-58", "marketing_start_date": "20250310"}], "brand_name": "Clobazam", "product_id": "68094-074_53326439-6544-44fa-b13c-6ea7517f4187", "dosage_form": "SUSPENSION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "68094-074", "dea_schedule": "CIV", "generic_name": "clobazam", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "2.5 mg/mL"}], "application_number": "ANDA210039", "marketing_category": "ANDA", "marketing_start_date": "20250310", "listing_expiration_date": "20261231"}