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 71610-771
Product ID 71610-771_134a7027-e823-4d80-80c2-3672d9123ca5
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 71610771
Hyphenated Format 71610-771

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 ANDA077856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE, PLASTIC (71610-771-15)
  • 28 TABLET in 1 BOTTLE, PLASTIC (71610-771-28)
  • 30 TABLET in 1 BOTTLE, PLASTIC (71610-771-30)
  • 45 TABLET in 1 BOTTLE, PLASTIC (71610-771-45)
  • 56 TABLET in 1 BOTTLE, PLASTIC (71610-771-46)
  • 60 TABLET in 1 BOTTLE, PLASTIC (71610-771-53)
  • 84 TABLET in 1 BOTTLE, PLASTIC (71610-771-54)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-771-60)
  • 120 TABLET in 1 BOTTLE, PLASTIC (71610-771-70)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-771-80)
source: ndc

Packages (10)

Ingredients (1)

clonazepam (1 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "134a7027-e823-4d80-80c2-3672d9123ca5", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197528"], "spl_set_id": ["2cb46dc0-a03e-42d7-ba67-22319598389f"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (71610-771-15)", "package_ndc": "71610-771-15", "marketing_start_date": "20240122"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (71610-771-28)", "package_ndc": "71610-771-28", "marketing_start_date": "20240122"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71610-771-30)", "package_ndc": "71610-771-30", "marketing_start_date": "20240125"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (71610-771-45)", "package_ndc": "71610-771-45", "marketing_start_date": "20240130"}, {"sample": false, "description": "56 TABLET in 1 BOTTLE, PLASTIC (71610-771-46)", "package_ndc": "71610-771-46", "marketing_start_date": "20240130"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71610-771-53)", "package_ndc": "71610-771-53", "marketing_start_date": "20240125"}, {"sample": false, "description": "84 TABLET in 1 BOTTLE, PLASTIC (71610-771-54)", "package_ndc": "71610-771-54", "marketing_start_date": "20240125"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-771-60)", "package_ndc": "71610-771-60", "marketing_start_date": "20240125"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (71610-771-70)", "package_ndc": "71610-771-70", "marketing_start_date": "20240125"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-771-80)", "package_ndc": "71610-771-80", "marketing_start_date": "20240122"}], "brand_name": "Clonazepam", "product_id": "71610-771_134a7027-e823-4d80-80c2-3672d9123ca5", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-771", "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": "ANDA077856", "marketing_category": "ANDA", "marketing_start_date": "20180215", "listing_expiration_date": "20261231"}