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 71610-368
Product ID 71610-368_24759da4-f035-bb20-e063-6294a90abca9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077856
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-02-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610368
Hyphenated Format 71610-368

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 ANDA077856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE, PLASTIC (71610-368-10)
  • 14 TABLET in 1 BOTTLE, PLASTIC (71610-368-14)
  • 15 TABLET in 1 BOTTLE, PLASTIC (71610-368-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (71610-368-20)
  • 28 TABLET in 1 BOTTLE, PLASTIC (71610-368-28)
  • 30 TABLET in 1 BOTTLE, PLASTIC (71610-368-30)
  • 45 TABLET in 1 BOTTLE, PLASTIC (71610-368-45)
  • 56 TABLET in 1 BOTTLE, PLASTIC (71610-368-46)
  • 60 TABLET in 1 BOTTLE, PLASTIC (71610-368-53)
  • 84 TABLET in 1 BOTTLE, PLASTIC (71610-368-54)
  • 75 TABLET in 1 BOTTLE, PLASTIC (71610-368-55)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-368-60)
  • 120 TABLET in 1 BOTTLE, PLASTIC (71610-368-70)
  • 150 TABLET in 1 BOTTLE, PLASTIC (71610-368-75)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-368-80)
  • 270 TABLET in 1 BOTTLE, PLASTIC (71610-368-92)
source: ndc

Packages (16)

71610-368-10 10 TABLET in 1 BOTTLE, PLASTIC (71610-368-10) 71610-368-14 14 TABLET in 1 BOTTLE, PLASTIC (71610-368-14) 71610-368-15 15 TABLET in 1 BOTTLE, PLASTIC (71610-368-15) 71610-368-20 20 TABLET in 1 BOTTLE, PLASTIC (71610-368-20) 71610-368-28 28 TABLET in 1 BOTTLE, PLASTIC (71610-368-28) 71610-368-30 30 TABLET in 1 BOTTLE, PLASTIC (71610-368-30) 71610-368-45 45 TABLET in 1 BOTTLE, PLASTIC (71610-368-45) 71610-368-46 56 TABLET in 1 BOTTLE, PLASTIC (71610-368-46) 71610-368-53 60 TABLET in 1 BOTTLE, PLASTIC (71610-368-53) 71610-368-54 84 TABLET in 1 BOTTLE, PLASTIC (71610-368-54) 71610-368-55 75 TABLET in 1 BOTTLE, PLASTIC (71610-368-55) 71610-368-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-368-60) 71610-368-70 120 TABLET in 1 BOTTLE, PLASTIC (71610-368-70) 71610-368-75 150 TABLET in 1 BOTTLE, PLASTIC (71610-368-75) 71610-368-80 180 TABLET in 1 BOTTLE, PLASTIC (71610-368-80) 71610-368-92 270 TABLET in 1 BOTTLE, PLASTIC (71610-368-92)

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": "24759da4-f035-bb20-e063-6294a90abca9", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197527"], "spl_set_id": ["66bf60fa-61ac-47a7-a081-36077af9007e"], "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, PLASTIC (71610-368-10)", "package_ndc": "71610-368-10", "marketing_start_date": "20200326"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (71610-368-14)", "package_ndc": "71610-368-14", "marketing_start_date": "20200326"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (71610-368-15)", "package_ndc": "71610-368-15", "marketing_start_date": "20200312"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (71610-368-20)", "package_ndc": "71610-368-20", "marketing_start_date": "20200326"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (71610-368-28)", "package_ndc": "71610-368-28", "marketing_start_date": "20200129"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71610-368-30)", "package_ndc": "71610-368-30", "marketing_start_date": "20200312"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (71610-368-45)", "package_ndc": "71610-368-45", "marketing_start_date": "20200312"}, {"sample": false, "description": "56 TABLET in 1 BOTTLE, PLASTIC (71610-368-46)", "package_ndc": "71610-368-46", "marketing_start_date": "20241014"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71610-368-53)", "package_ndc": "71610-368-53", "marketing_start_date": "20191120"}, {"sample": false, "description": "84 TABLET in 1 BOTTLE, PLASTIC (71610-368-54)", "package_ndc": "71610-368-54", "marketing_start_date": "20200129"}, {"sample": false, "description": "75 TABLET in 1 BOTTLE, PLASTIC (71610-368-55)", "package_ndc": "71610-368-55", "marketing_start_date": "20200508"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-368-60)", "package_ndc": "71610-368-60", "marketing_start_date": "20191120"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (71610-368-70)", "package_ndc": "71610-368-70", "marketing_start_date": "20191204"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE, PLASTIC (71610-368-75)", "package_ndc": "71610-368-75", "marketing_start_date": "20200423"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-368-80)", "package_ndc": "71610-368-80", "marketing_start_date": "20200403"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE, PLASTIC (71610-368-92)", "package_ndc": "71610-368-92", "marketing_start_date": "20191204"}], "brand_name": "Clonazepam", "product_id": "71610-368_24759da4-f035-bb20-e063-6294a90abca9", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-368", "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": "ANDA077856", "marketing_category": "ANDA", "marketing_start_date": "20180215", "listing_expiration_date": "20261231"}