clonazepam

Generic: clonazepam

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clonazepam
Generic Name clonazepam
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clonazepam .5 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0358
Product ID 80425-0358_2a99a670-af28-299d-e063-6294a90a05d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077147
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-09-08

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250358
Hyphenated Format 80425-0358

Supplemental Identifiers

RxCUI
197527
UNII
5PE9FDE8GB
NUI
N0000175694 M0002356

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 clonazepam (source: ndc)
Generic Name clonazepam (source: ndc)
Application Number ANDA077147 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (80425-0358-1)
  • 60 TABLET in 1 BOTTLE, PLASTIC (80425-0358-2)
  • 90 TABLET in 1 BOTTLE, PLASTIC (80425-0358-3)
source: ndc

Packages (3)

80425-0358-1 30 TABLET in 1 BOTTLE, PLASTIC (80425-0358-1) 80425-0358-2 60 TABLET in 1 BOTTLE, PLASTIC (80425-0358-2) 80425-0358-3 90 TABLET in 1 BOTTLE, PLASTIC (80425-0358-3)

Ingredients (1)

clonazepam (.5 mg/1)

Linked Drug Pages (1)

Clonazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a99a670-af28-299d-e063-6294a90a05d2", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197527"], "spl_set_id": ["04db8e8c-38f9-0c4a-e063-6394a90a93f0"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (80425-0358-1)", "package_ndc": "80425-0358-1", "marketing_start_date": "20230908"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (80425-0358-2)", "package_ndc": "80425-0358-2", "marketing_start_date": "20230908"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (80425-0358-3)", "package_ndc": "80425-0358-3", "marketing_start_date": "20230908"}], "brand_name": "Clonazepam", "product_id": "80425-0358_2a99a670-af28-299d-e063-6294a90a05d2", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "80425-0358", "dea_schedule": "CIV", "generic_name": "clonazepam", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clonazepam", "active_ingredients": [{"name": "CLONAZEPAM", "strength": ".5 mg/1"}], "application_number": "ANDA077147", "marketing_category": "ANDA", "marketing_start_date": "20230908", "listing_expiration_date": "20261231"}