clobazam

Generic: clobazam

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clobazam 20 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1306
Product ID 69238-1306_a15a2ac8-fb25-4094-af85-fa11ab7e0c08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209718
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2018-10-22

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 692381306
Hyphenated Format 69238-1306

Supplemental Identifiers

RxCUI
199450 246172
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 ANDA209718 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69238-1306-1)
source: ndc

Packages (1)

69238-1306-1 100 TABLET in 1 BOTTLE (69238-1306-1)

Ingredients (1)

clobazam (20 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": "a15a2ac8-fb25-4094-af85-fa11ab7e0c08", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "unii": ["2MRO291B4U"], "rxcui": ["199450", "246172"], "spl_set_id": ["6783eaa8-e236-4957-aaa9-b42bf8e709a7"], "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": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69238-1306-1)", "package_ndc": "69238-1306-1", "marketing_start_date": "20181022"}], "brand_name": "CLOBAZAM", "product_id": "69238-1306_a15a2ac8-fb25-4094-af85-fa11ab7e0c08", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "69238-1306", "dea_schedule": "CIV", "generic_name": "CLOBAZAM", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOBAZAM", "active_ingredients": [{"name": "CLOBAZAM", "strength": "20 mg/1"}], "application_number": "ANDA209718", "marketing_category": "ANDA", "marketing_start_date": "20181022", "listing_expiration_date": "20271231"}