clobazam

Generic: clobazam

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobazam
Generic Name clobazam
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clobazam 20 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-158
Product ID 68180-158_ce8d2e9b-0cf3-4206-9523-6f0df27953b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210545
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-05-08

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 68180158
Hyphenated Format 68180-158

Supplemental Identifiers

RxCUI
199450 246172
UPC
0368180158011 0368180157014
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 ANDA210545 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68180-158-01) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

68180-158-01 1 BOTTLE in 1 CARTON (68180-158-01) / 100 TABLET in 1 BOTTLE

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": "ce8d2e9b-0cf3-4206-9523-6f0df27953b8", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "upc": ["0368180158011", "0368180157014"], "unii": ["2MRO291B4U"], "rxcui": ["199450", "246172"], "spl_set_id": ["d9e03a2a-3fea-4c98-ab71-415e6ebda3e0"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68180-158-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "68180-158-01", "marketing_start_date": "20190508"}], "brand_name": "Clobazam", "product_id": "68180-158_ce8d2e9b-0cf3-4206-9523-6f0df27953b8", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "68180-158", "dea_schedule": "CIV", "generic_name": "Clobazam", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "20 mg/1"}], "application_number": "ANDA210545", "marketing_category": "ANDA", "marketing_start_date": "20190508", "listing_expiration_date": "20261231"}