clobazam

Generic: clobazam

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clobazam 20 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-316
Product ID 42571-316_3afc2af9-3600-3648-e063-6394a90a7e51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211711
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-04-02

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 42571316
Hyphenated Format 42571-316

Supplemental Identifiers

RxCUI
199450 246172
UPC
0342571315016 0342571316013
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 ANDA211711 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42571-316-01)
  • 100 BLISTER PACK in 1 CARTON (42571-316-11) / 10 TABLET in 1 BLISTER PACK (42571-316-32)
  • 30 TABLET in 1 BOTTLE (42571-316-30)
  • 90 TABLET in 1 BOTTLE (42571-316-90)
  • 100 BLISTER PACK in 1 CARTON (42571-316-91) / 10 TABLET in 1 BLISTER PACK (42571-316-20)
source: ndc

Packages (5)

42571-316-01 100 TABLET in 1 BOTTLE (42571-316-01) 42571-316-11 100 BLISTER PACK in 1 CARTON (42571-316-11) / 10 TABLET in 1 BLISTER PACK (42571-316-32) 42571-316-30 30 TABLET in 1 BOTTLE (42571-316-30) 42571-316-90 90 TABLET in 1 BOTTLE (42571-316-90) 42571-316-91 100 BLISTER PACK in 1 CARTON (42571-316-91) / 10 TABLET in 1 BLISTER PACK (42571-316-20)

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": "3afc2af9-3600-3648-e063-6394a90a7e51", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "upc": ["0342571315016", "0342571316013"], "unii": ["2MRO291B4U"], "rxcui": ["199450", "246172"], "spl_set_id": ["721dde68-db83-4dad-8649-8046cb455372"], "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": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42571-316-01)", "package_ndc": "42571-316-01", "marketing_start_date": "20190402"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (42571-316-11)  / 10 TABLET in 1 BLISTER PACK (42571-316-32)", "package_ndc": "42571-316-11", "marketing_start_date": "20190402"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-316-30)", "package_ndc": "42571-316-30", "marketing_start_date": "20190402"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42571-316-90)", "package_ndc": "42571-316-90", "marketing_start_date": "20190402"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (42571-316-91)  / 10 TABLET in 1 BLISTER PACK (42571-316-20)", "package_ndc": "42571-316-91", "marketing_start_date": "20190402"}], "brand_name": "Clobazam", "product_id": "42571-316_3afc2af9-3600-3648-e063-6394a90a7e51", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "42571-316", "dea_schedule": "CIV", "generic_name": "Clobazam", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "20 mg/1"}], "application_number": "ANDA211711", "marketing_category": "ANDA", "marketing_start_date": "20190402", "listing_expiration_date": "20261231"}