clonazepam

Generic: clonazepam

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clonazepam
Generic Name clonazepam
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clonazepam .5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3891
Product ID 70518-3891_3b2aa260-0636-7a25-e063-6294a90a3a89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075468
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183891
Hyphenated Format 70518-3891

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 ANDA075468 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3891-0)
  • 100 POUCH in 1 BOX (70518-3891-1) / 1 TABLET in 1 POUCH (70518-3891-2)
  • 100 POUCH in 1 BOX (70518-3891-3) / 1 TABLET in 1 POUCH (70518-3891-4)
source: ndc

Packages (3)

70518-3891-0 30 TABLET in 1 BLISTER PACK (70518-3891-0) 70518-3891-1 100 POUCH in 1 BOX (70518-3891-1) / 1 TABLET in 1 POUCH (70518-3891-2) 70518-3891-3 100 POUCH in 1 BOX (70518-3891-3) / 1 TABLET in 1 POUCH (70518-3891-4)

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": "3b2aa260-0636-7a25-e063-6294a90a3a89", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["5PE9FDE8GB"], "rxcui": ["197527"], "spl_set_id": ["9c3b1b37-8bc0-427a-8c7a-14da7bd49a7f"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3891-0)", "package_ndc": "70518-3891-0", "marketing_start_date": "20231010"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-3891-1)  / 1 TABLET in 1 POUCH (70518-3891-2)", "package_ndc": "70518-3891-1", "marketing_start_date": "20231019"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-3891-3)  / 1 TABLET in 1 POUCH (70518-3891-4)", "package_ndc": "70518-3891-3", "marketing_start_date": "20250107"}], "brand_name": "Clonazepam", "product_id": "70518-3891_3b2aa260-0636-7a25-e063-6294a90a3a89", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "70518-3891", "dea_schedule": "CIV", "generic_name": "Clonazepam", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clonazepam", "active_ingredients": [{"name": "CLONAZEPAM", "strength": ".5 mg/1"}], "application_number": "ANDA075468", "marketing_category": "ANDA", "marketing_start_date": "20231010", "listing_expiration_date": "20261231"}