clobazam

Generic: clobazam

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clobazam 10 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-423
Product ID 60687-423_3d5d1f23-c639-3604-e063-6294a90ac606
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209718
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-01-17

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 60687423
Hyphenated Format 60687-423

Supplemental Identifiers

RxCUI
199450
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 ANDA209718 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-423-21) / 1 TABLET in 1 BLISTER PACK (60687-423-11)
source: ndc

Packages (1)

60687-423-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-423-21) / 1 TABLET in 1 BLISTER PACK (60687-423-11)

Ingredients (1)

clobazam (10 mg/1)

Linked Drug Pages (1)

Clobazam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d5d1f23-c639-3604-e063-6294a90ac606", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "unii": ["2MRO291B4U"], "rxcui": ["199450"], "spl_set_id": ["8fce3252-95f8-4428-9922-5ba308e20177"], "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": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-423-21)  / 1 TABLET in 1 BLISTER PACK (60687-423-11)", "package_ndc": "60687-423-21", "marketing_start_date": "20190117"}], "brand_name": "Clobazam", "product_id": "60687-423_3d5d1f23-c639-3604-e063-6294a90ac606", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "60687-423", "dea_schedule": "CIV", "generic_name": "Clobazam", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "10 mg/1"}], "application_number": "ANDA209718", "marketing_category": "ANDA", "marketing_start_date": "20190117", "listing_expiration_date": "20261231"}