clobazam

Generic: clobazam

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler northstar rxllc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clobazam 20 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-888
Product ID 16714-888_223818f1-9350-07e9-e063-6294a90ab33a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209795
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-11-12

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 16714888
Hyphenated Format 16714-888

Supplemental Identifiers

RxCUI
199450 246172
UPC
0316714888019 0316714887012
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 ANDA209795 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16714-888-01)
source: ndc

Packages (1)

16714-888-01 100 TABLET in 1 BOTTLE (16714-888-01)

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": "223818f1-9350-07e9-e063-6294a90ab33a", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "upc": ["0316714888019", "0316714887012"], "unii": ["2MRO291B4U"], "rxcui": ["199450", "246172"], "spl_set_id": ["6f94e10e-ee4e-44e1-9c84-16c5d8c9b594"], "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": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16714-888-01)", "package_ndc": "16714-888-01", "marketing_start_date": "20181112"}], "brand_name": "Clobazam", "product_id": "16714-888_223818f1-9350-07e9-e063-6294a90ab33a", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "16714-888", "dea_schedule": "CIV", "generic_name": "Clobazam", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "20 mg/1"}], "application_number": "ANDA209795", "marketing_category": "ANDA", "marketing_start_date": "20181112", "listing_expiration_date": "20261231"}