clonazepam

Generic: clonazepam

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clonazepam
Generic Name clonazepam
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clonazepam .5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-797
Product ID 43063-797_415b8bf8-892a-0f23-e063-6394a90a8856
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077147
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-01-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063797
Hyphenated Format 43063-797

Supplemental Identifiers

RxCUI
197527
UPC
0343063797600
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
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-797-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-797-60)
source: ndc

Packages (2)

43063-797-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-797-30) 43063-797-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-797-60)

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": "415b8bf8-892a-0f23-e063-6394a90a8856", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0343063797600"], "unii": ["5PE9FDE8GB"], "rxcui": ["197527"], "spl_set_id": ["c707caa1-d6fd-4790-9a64-f749bf93ef18"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-797-30)", "package_ndc": "43063-797-30", "marketing_start_date": "20180119"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-797-60)", "package_ndc": "43063-797-60", "marketing_start_date": "20180119"}], "brand_name": "Clonazepam", "product_id": "43063-797_415b8bf8-892a-0f23-e063-6394a90a8856", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43063-797", "dea_schedule": "CIV", "generic_name": "clonazepam", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20180119", "listing_expiration_date": "20261231"}