clobazam

Generic: clobazam

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clobazam 10 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-665
Product ID 67877-665_f9dc8ac4-86be-49ab-9c2c-c60658f49d8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212714
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-09-07

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 67877665
Hyphenated Format 67877-665

Supplemental Identifiers

RxCUI
199450 246172 427538
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 ANDA212714 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CARTON in 1 CONTAINER (67877-665-01) / 1 TABLET in 1 CARTON
  • 500 TABLET in 1 CONTAINER (67877-665-05)
  • 10 CARTON in 1 BLISTER PACK (67877-665-33) / 1 TABLET in 1 CARTON
source: ndc

Packages (3)

Ingredients (1)

clobazam (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "f9dc8ac4-86be-49ab-9c2c-c60658f49d8f", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "unii": ["2MRO291B4U"], "rxcui": ["199450", "246172", "427538"], "spl_set_id": ["a77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f"], "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": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CARTON in 1 CONTAINER (67877-665-01)  / 1 TABLET in 1 CARTON", "package_ndc": "67877-665-01", "marketing_start_date": "20190907"}, {"sample": false, "description": "500 TABLET in 1 CONTAINER (67877-665-05)", "package_ndc": "67877-665-05", "marketing_start_date": "20190907"}, {"sample": false, "description": "10 CARTON in 1 BLISTER PACK (67877-665-33)  / 1 TABLET in 1 CARTON", "package_ndc": "67877-665-33", "marketing_start_date": "20190907"}], "brand_name": "Clobazam", "product_id": "67877-665_f9dc8ac4-86be-49ab-9c2c-c60658f49d8f", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "67877-665", "dea_schedule": "CIV", "generic_name": "Clobazam", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "10 mg/1"}], "application_number": "ANDA212714", "marketing_category": "ANDA", "marketing_start_date": "20190907", "listing_expiration_date": "20261231"}