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 67544-529
Product ID 67544-529_2458678c-6ce9-4fa4-976a-2c49b489a834
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074569
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1996-09-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67544529
Hyphenated Format 67544-529

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 ANDA074569 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (67544-529-10)
  • 15 TABLET in 1 BOTTLE (67544-529-15)
  • 28 TABLET in 1 BOTTLE (67544-529-28)
  • 30 TABLET in 1 BOTTLE (67544-529-30)
  • 45 TABLET in 1 BOTTLE (67544-529-45)
  • 60 TABLET in 1 BOTTLE (67544-529-53)
  • 84 TABLET in 1 BOTTLE (67544-529-54)
  • 75 TABLET in 1 BOTTLE (67544-529-55)
  • 90 TABLET in 1 BOTTLE (67544-529-60)
  • 120 TABLET in 1 BOTTLE (67544-529-70)
  • 150 TABLET in 1 BOTTLE (67544-529-75)
  • 180 TABLET in 1 BOTTLE (67544-529-80)
source: ndc

Packages (12)

67544-529-10 10 TABLET in 1 BOTTLE (67544-529-10) 67544-529-15 15 TABLET in 1 BOTTLE (67544-529-15) 67544-529-28 28 TABLET in 1 BOTTLE (67544-529-28) 67544-529-30 30 TABLET in 1 BOTTLE (67544-529-30) 67544-529-45 45 TABLET in 1 BOTTLE (67544-529-45) 67544-529-53 60 TABLET in 1 BOTTLE (67544-529-53) 67544-529-54 84 TABLET in 1 BOTTLE (67544-529-54) 67544-529-55 75 TABLET in 1 BOTTLE (67544-529-55) 67544-529-60 90 TABLET in 1 BOTTLE (67544-529-60) 67544-529-70 120 TABLET in 1 BOTTLE (67544-529-70) 67544-529-75 150 TABLET in 1 BOTTLE (67544-529-75) 67544-529-80 180 TABLET in 1 BOTTLE (67544-529-80)

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": "2458678c-6ce9-4fa4-976a-2c49b489a834", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197527"], "spl_set_id": ["6be64dc3-3748-477c-8800-2c2175309c73"], "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 (67544-529-10)", "package_ndc": "67544-529-10", "marketing_start_date": "20230714"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (67544-529-15)", "package_ndc": "67544-529-15", "marketing_start_date": "20180306"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (67544-529-28)", "package_ndc": "67544-529-28", "marketing_start_date": "20230714"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67544-529-30)", "package_ndc": "67544-529-30", "marketing_start_date": "20180306"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (67544-529-45)", "package_ndc": "67544-529-45", "marketing_start_date": "20180306"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (67544-529-53)", "package_ndc": "67544-529-53", "marketing_start_date": "20180306"}, {"sample": false, "description": "84 TABLET in 1 BOTTLE (67544-529-54)", "package_ndc": "67544-529-54", "marketing_start_date": "20230714"}, {"sample": false, "description": "75 TABLET in 1 BOTTLE (67544-529-55)", "package_ndc": "67544-529-55", "marketing_start_date": "20230714"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (67544-529-60)", "package_ndc": "67544-529-60", "marketing_start_date": "20180306"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (67544-529-70)", "package_ndc": "67544-529-70", "marketing_start_date": "20180306"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (67544-529-75)", "package_ndc": "67544-529-75", "marketing_start_date": "20180306"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (67544-529-80)", "package_ndc": "67544-529-80", "marketing_start_date": "20180306"}], "brand_name": "Clonazepam", "product_id": "67544-529_2458678c-6ce9-4fa4-976a-2c49b489a834", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "67544-529", "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": "ANDA074569", "marketing_category": "ANDA", "marketing_start_date": "19960918", "listing_expiration_date": "20261231"}