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 .5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-855
Product ID 71610-855_2513f819-46bf-89c8-e063-6394a90a5199
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 71610855
Hyphenated Format 71610-855

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 ANDA075150 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (71610-855-10)
  • 14 TABLET in 1 BOTTLE (71610-855-14)
  • 15 TABLET in 1 BOTTLE (71610-855-15)
  • 20 TABLET in 1 BOTTLE (71610-855-20)
  • 28 TABLET in 1 BOTTLE (71610-855-28)
  • 30 TABLET in 1 BOTTLE (71610-855-30)
  • 45 TABLET in 1 BOTTLE (71610-855-45)
  • 60 TABLET in 1 BOTTLE (71610-855-53)
  • 84 TABLET in 1 BOTTLE (71610-855-54)
  • 90 TABLET in 1 BOTTLE (71610-855-60)
  • 120 TABLET in 1 BOTTLE (71610-855-70)
  • 180 TABLET in 1 BOTTLE (71610-855-80)
source: ndc

Packages (12)

71610-855-10 10 TABLET in 1 BOTTLE (71610-855-10) 71610-855-14 14 TABLET in 1 BOTTLE (71610-855-14) 71610-855-15 15 TABLET in 1 BOTTLE (71610-855-15) 71610-855-20 20 TABLET in 1 BOTTLE (71610-855-20) 71610-855-28 28 TABLET in 1 BOTTLE (71610-855-28) 71610-855-30 30 TABLET in 1 BOTTLE (71610-855-30) 71610-855-45 45 TABLET in 1 BOTTLE (71610-855-45) 71610-855-53 60 TABLET in 1 BOTTLE (71610-855-53) 71610-855-54 84 TABLET in 1 BOTTLE (71610-855-54) 71610-855-60 90 TABLET in 1 BOTTLE (71610-855-60) 71610-855-70 120 TABLET in 1 BOTTLE (71610-855-70) 71610-855-80 180 TABLET in 1 BOTTLE (71610-855-80)

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": "2513f819-46bf-89c8-e063-6394a90a5199", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197527"], "spl_set_id": ["214e760b-c909-bd93-e063-6294a90ae74a"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (71610-855-10)", "package_ndc": "71610-855-10", "marketing_start_date": "20241018"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (71610-855-14)", "package_ndc": "71610-855-14", "marketing_start_date": "20241018"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-855-15)", "package_ndc": "71610-855-15", "marketing_start_date": "20241018"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71610-855-20)", "package_ndc": "71610-855-20", "marketing_start_date": "20240903"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71610-855-28)", "package_ndc": "71610-855-28", "marketing_start_date": "20241018"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-855-30)", "package_ndc": "71610-855-30", "marketing_start_date": "20240903"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-855-45)", "package_ndc": "71610-855-45", "marketing_start_date": "20241018"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-855-53)", "package_ndc": "71610-855-53", "marketing_start_date": "20240903"}, {"sample": false, "description": "84 TABLET in 1 BOTTLE (71610-855-54)", "package_ndc": "71610-855-54", "marketing_start_date": "20241018"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-855-60)", "package_ndc": "71610-855-60", "marketing_start_date": "20240903"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-855-70)", "package_ndc": "71610-855-70", "marketing_start_date": "20240903"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-855-80)", "package_ndc": "71610-855-80", "marketing_start_date": "20240903"}], "brand_name": "Clonazepam", "product_id": "71610-855_2513f819-46bf-89c8-e063-6394a90a5199", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-855", "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": ".5 mg/1"}], "application_number": "ANDA075150", "marketing_category": "ANDA", "marketing_start_date": "20230117", "listing_expiration_date": "20261231"}