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 SUSPENSION
Routes
ORAL
Active Ingredients

clobazam 2.5 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-087
Product ID 16714-087_f649cb16-8cb4-5292-e053-2995a90a04fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209796
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-05-01

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 16714087
Hyphenated Format 16714-087

Supplemental Identifiers

RxCUI
1366192
UPC
0316714087016
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 ANDA209796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (16714-087-01) / 120 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

16714-087-01 1 BOTTLE, GLASS in 1 CARTON (16714-087-01) / 120 mL in 1 BOTTLE, GLASS

Ingredients (1)

clobazam (2.5 mg/mL)

Linked Drug Pages (1)

Clobazam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f649cb16-8cb4-5292-e053-2995a90a04fc", "openfda": {"nui": ["N0000175694", "M0002356", "N0000182137", "N0000185506"], "upc": ["0316714087016"], "unii": ["2MRO291B4U"], "rxcui": ["1366192"], "spl_set_id": ["574a3f91-d73e-46bc-b4a1-2388439521fb"], "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": "1 BOTTLE, GLASS in 1 CARTON (16714-087-01)  / 120 mL in 1 BOTTLE, GLASS", "package_ndc": "16714-087-01", "marketing_start_date": "20200501"}], "brand_name": "Clobazam", "product_id": "16714-087_f649cb16-8cb4-5292-e053-2995a90a04fc", "dosage_form": "SUSPENSION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "16714-087", "dea_schedule": "CIV", "generic_name": "Clobazam", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobazam", "active_ingredients": [{"name": "CLOBAZAM", "strength": "2.5 mg/mL"}], "application_number": "ANDA209796", "marketing_category": "ANDA", "marketing_start_date": "20200501", "listing_expiration_date": "20261231"}