clonazepam

Generic: clonazepam

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clonazepam
Generic Name clonazepam
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clonazepam 1 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-852
Product ID 71610-852_20b33aac-b9ba-2743-e063-6294a90ae043
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075150
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-01-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610852
Hyphenated Format 71610-852

Supplemental Identifiers

RxCUI
197528
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 ANDA075150 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BOTTLE (71610-852-12)
  • 15 TABLET in 1 BOTTLE (71610-852-15)
  • 28 TABLET in 1 BOTTLE (71610-852-28)
  • 30 TABLET in 1 BOTTLE (71610-852-30)
  • 45 TABLET in 1 BOTTLE (71610-852-45)
  • 56 TABLET in 1 BOTTLE (71610-852-46)
  • 60 TABLET in 1 BOTTLE (71610-852-53)
  • 90 TABLET in 1 BOTTLE (71610-852-60)
  • 180 TABLET in 1 BOTTLE (71610-852-80)
source: ndc

Packages (9)

71610-852-12 12 TABLET in 1 BOTTLE (71610-852-12) 71610-852-15 15 TABLET in 1 BOTTLE (71610-852-15) 71610-852-28 28 TABLET in 1 BOTTLE (71610-852-28) 71610-852-30 30 TABLET in 1 BOTTLE (71610-852-30) 71610-852-45 45 TABLET in 1 BOTTLE (71610-852-45) 71610-852-46 56 TABLET in 1 BOTTLE (71610-852-46) 71610-852-53 60 TABLET in 1 BOTTLE (71610-852-53) 71610-852-60 90 TABLET in 1 BOTTLE (71610-852-60) 71610-852-80 180 TABLET in 1 BOTTLE (71610-852-80)

Ingredients (1)

clonazepam (1 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": "20b33aac-b9ba-2743-e063-6294a90ae043", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197528"], "spl_set_id": ["20b3125e-4489-3c53-e063-6294a90a6539"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE (71610-852-12)", "package_ndc": "71610-852-12", "marketing_start_date": "20240827"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-852-15)", "package_ndc": "71610-852-15", "marketing_start_date": "20240828"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71610-852-28)", "package_ndc": "71610-852-28", "marketing_start_date": "20240827"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-852-30)", "package_ndc": "71610-852-30", "marketing_start_date": "20240827"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-852-45)", "package_ndc": "71610-852-45", "marketing_start_date": "20240827"}, {"sample": false, "description": "56 TABLET in 1 BOTTLE (71610-852-46)", "package_ndc": "71610-852-46", "marketing_start_date": "20240827"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-852-53)", "package_ndc": "71610-852-53", "marketing_start_date": "20240827"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-852-60)", "package_ndc": "71610-852-60", "marketing_start_date": "20240827"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-852-80)", "package_ndc": "71610-852-80", "marketing_start_date": "20240827"}], "brand_name": "Clonazepam", "product_id": "71610-852_20b33aac-b9ba-2743-e063-6294a90ae043", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-852", "dea_schedule": "CIV", "generic_name": "Clonazepam", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clonazepam", "active_ingredients": [{"name": "CLONAZEPAM", "strength": "1 mg/1"}], "application_number": "ANDA075150", "marketing_category": "ANDA", "marketing_start_date": "20230117", "listing_expiration_date": "20261231"}