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 2 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-817
Product ID 71610-817_15485723-3baa-bb76-e063-6294a90a1628
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 71610817
Hyphenated Format 71610-817

Supplemental Identifiers

RxCUI
197529
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
  • 2 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-817-15)
  • 30 TABLET in 1 BOTTLE (71610-817-30)
  • 45 TABLET in 1 BOTTLE (71610-817-45)
  • 56 TABLET in 1 BOTTLE (71610-817-46)
  • 60 TABLET in 1 BOTTLE (71610-817-53)
  • 90 TABLET in 1 BOTTLE (71610-817-60)
  • 120 TABLET in 1 BOTTLE (71610-817-70)
source: ndc

Packages (7)

Ingredients (1)

clonazepam (2 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "15485723-3baa-bb76-e063-6294a90a1628", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197529"], "spl_set_id": ["154806ed-91af-fc7f-e063-6294a90ae0f4"], "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 (71610-817-15)", "package_ndc": "71610-817-15", "marketing_start_date": "20240403"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-817-30)", "package_ndc": "71610-817-30", "marketing_start_date": "20240403"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-817-45)", "package_ndc": "71610-817-45", "marketing_start_date": "20240403"}, {"sample": false, "description": "56 TABLET in 1 BOTTLE (71610-817-46)", "package_ndc": "71610-817-46", "marketing_start_date": "20240403"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-817-53)", "package_ndc": "71610-817-53", "marketing_start_date": "20240403"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-817-60)", "package_ndc": "71610-817-60", "marketing_start_date": "20240403"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-817-70)", "package_ndc": "71610-817-70", "marketing_start_date": "20240403"}], "brand_name": "Clonazepam", "product_id": "71610-817_15485723-3baa-bb76-e063-6294a90a1628", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-817", "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": "2 mg/1"}], "application_number": "ANDA077856", "marketing_category": "ANDA", "marketing_start_date": "20180215", "listing_expiration_date": "20261231"}