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 71610-790
Product ID 71610-790_2528d6db-eb77-3ccc-e063-6294a90a3022
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075468
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2022-04-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610790
Hyphenated Format 71610-790

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 ANDA075468 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (71610-790-10)
  • 15 TABLET in 1 BOTTLE (71610-790-15)
  • 20 TABLET in 1 BOTTLE (71610-790-20)
  • 28 TABLET in 1 BOTTLE (71610-790-28)
  • 30 TABLET in 1 BOTTLE (71610-790-30)
  • 45 TABLET in 1 BOTTLE (71610-790-45)
  • 56 TABLET in 1 BOTTLE (71610-790-46)
  • 60 TABLET in 1 BOTTLE (71610-790-53)
  • 75 TABLET in 1 BOTTLE (71610-790-55)
  • 90 TABLET in 1 BOTTLE (71610-790-60)
  • 120 TABLET in 1 BOTTLE (71610-790-70)
source: ndc

Packages (11)

71610-790-10 10 TABLET in 1 BOTTLE (71610-790-10) 71610-790-15 15 TABLET in 1 BOTTLE (71610-790-15) 71610-790-20 20 TABLET in 1 BOTTLE (71610-790-20) 71610-790-28 28 TABLET in 1 BOTTLE (71610-790-28) 71610-790-30 30 TABLET in 1 BOTTLE (71610-790-30) 71610-790-45 45 TABLET in 1 BOTTLE (71610-790-45) 71610-790-46 56 TABLET in 1 BOTTLE (71610-790-46) 71610-790-53 60 TABLET in 1 BOTTLE (71610-790-53) 71610-790-55 75 TABLET in 1 BOTTLE (71610-790-55) 71610-790-60 90 TABLET in 1 BOTTLE (71610-790-60) 71610-790-70 120 TABLET in 1 BOTTLE (71610-790-70)

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": "2528d6db-eb77-3ccc-e063-6294a90a3022", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197527"], "spl_set_id": ["8891c5aa-f42a-4206-92b9-f0ed0631dfcb"], "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 (71610-790-10)", "package_ndc": "71610-790-10", "marketing_start_date": "20241023"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-790-15)", "package_ndc": "71610-790-15", "marketing_start_date": "20240125"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71610-790-20)", "package_ndc": "71610-790-20", "marketing_start_date": "20240205"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71610-790-28)", "package_ndc": "71610-790-28", "marketing_start_date": "20240125"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-790-30)", "package_ndc": "71610-790-30", "marketing_start_date": "20241023"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-790-45)", "package_ndc": "71610-790-45", "marketing_start_date": "20241023"}, {"sample": false, "description": "56 TABLET in 1 BOTTLE (71610-790-46)", "package_ndc": "71610-790-46", "marketing_start_date": "20241023"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-790-53)", "package_ndc": "71610-790-53", "marketing_start_date": "20241023"}, {"sample": false, "description": "75 TABLET in 1 BOTTLE (71610-790-55)", "package_ndc": "71610-790-55", "marketing_start_date": "20240125"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-790-60)", "package_ndc": "71610-790-60", "marketing_start_date": "20240125"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-790-70)", "package_ndc": "71610-790-70", "marketing_start_date": "20240125"}], "brand_name": "Clonazepam", "product_id": "71610-790_2528d6db-eb77-3ccc-e063-6294a90a3022", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-790", "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": "ANDA075468", "marketing_category": "ANDA", "marketing_start_date": "20220414", "listing_expiration_date": "20261231"}