onfi

Generic: clobazam

Labeler: lundbeck pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name onfi
Generic Name clobazam
Labeler lundbeck pharmaceuticals llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

clobazam 2.5 mg/mL

Manufacturer
Lundbeck Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 67386-313
Product ID 67386-313_68dbe31c-2dbe-49ad-8b2e-2cf1b8521167
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203993
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-12-14

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 67386313
Hyphenated Format 67386-313

Supplemental Identifiers

RxCUI
199450 246172 1191056 1191058 1366192 1366196
UPC
0367386314016
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 onfi (source: ndc)
Generic Name clobazam (source: ndc)
Application Number NDA203993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (67386-313-21) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

67386-313-21 1 BOTTLE in 1 CARTON (67386-313-21) / 120 mL in 1 BOTTLE

Ingredients (1)

clobazam (2.5 mg/mL)

Linked Drug Pages (1)

Onfi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "68dbe31c-2dbe-49ad-8b2e-2cf1b8521167", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "upc": ["0367386314016"], "unii": ["2MRO291B4U"], "rxcui": ["199450", "246172", "1191056", "1191058", "1366192", "1366196"], "spl_set_id": ["de03bd69-2dca-459c-93b4-541fd3e9571c"], "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": ["Lundbeck Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (67386-313-21)  / 120 mL in 1 BOTTLE", "package_ndc": "67386-313-21", "marketing_start_date": "20121214"}], "brand_name": "Onfi", "product_id": "67386-313_68dbe31c-2dbe-49ad-8b2e-2cf1b8521167", "dosage_form": "SUSPENSION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "67386-313", "dea_schedule": "CIV", "generic_name": "clobazam", "labeler_name": "Lundbeck Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Onfi", "active_ingredients": [{"name": "CLOBAZAM", "strength": "2.5 mg/mL"}], "application_number": "NDA203993", "marketing_category": "NDA", "marketing_start_date": "20121214", "listing_expiration_date": "20261231"}