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 71610-039
Product ID 71610-039_2343727e-d408-e54a-e063-6394a90a3142
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077147
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2011-06-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610039
Hyphenated Format 71610-039

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 ANDA077147 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE, PLASTIC (71610-039-45)
  • 60 TABLET in 1 BOTTLE, PLASTIC (71610-039-53)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-039-60)
  • 120 TABLET in 1 BOTTLE, PLASTIC (71610-039-70)
source: ndc

Packages (4)

71610-039-45 45 TABLET in 1 BOTTLE, PLASTIC (71610-039-45) 71610-039-53 60 TABLET in 1 BOTTLE, PLASTIC (71610-039-53) 71610-039-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-039-60) 71610-039-70 120 TABLET in 1 BOTTLE, PLASTIC (71610-039-70)

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": "2343727e-d408-e54a-e063-6394a90a3142", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197527"], "spl_set_id": ["7b0d716c-8f51-47a7-8bf2-07c6f9732a05"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (71610-039-45)", "package_ndc": "71610-039-45", "marketing_start_date": "20180214"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71610-039-53)", "package_ndc": "71610-039-53", "marketing_start_date": "20180214"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-039-60)", "package_ndc": "71610-039-60", "marketing_start_date": "20180214"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (71610-039-70)", "package_ndc": "71610-039-70", "marketing_start_date": "20240927"}], "brand_name": "Clonazepam", "product_id": "71610-039_2343727e-d408-e54a-e063-6394a90a3142", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-039", "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": "ANDA077147", "marketing_category": "ANDA", "marketing_start_date": "20110603", "listing_expiration_date": "20261231"}