clorazepate dipotassium

Generic: clorazepate dipotassium

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clorazepate dipotassium
Generic Name clorazepate dipotassium
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clorazepate dipotassium 3.75 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-159
Product ID 70954-159_d4edcb5d-dbe9-44c4-a0a9-d3b6aba4c22d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213730
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2022-06-16

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954159
Hyphenated Format 70954-159

Supplemental Identifiers

RxCUI
197464 197465 197466
UNII
63FN7G03XY

Packaging Origin

Original Packager
true

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 clorazepate dipotassium (source: ndc)
Generic Name clorazepate dipotassium (source: ndc)
Application Number ANDA213730 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-159-10)
  • 500 TABLET in 1 BOTTLE (70954-159-20)
  • 30 TABLET in 1 BOTTLE (70954-159-30)
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (70954-159-50) / 1 TABLET in 1 BLISTER PACK (70954-159-40)
source: ndc

Packages (4)

70954-159-10 100 TABLET in 1 BOTTLE (70954-159-10) 70954-159-20 500 TABLET in 1 BOTTLE (70954-159-20) 70954-159-30 30 TABLET in 1 BOTTLE (70954-159-30) 70954-159-50 30 BLISTER PACK in 1 BOX, UNIT-DOSE (70954-159-50) / 1 TABLET in 1 BLISTER PACK (70954-159-40)

Ingredients (1)

clorazepate dipotassium (3.75 mg/1)

Linked Drug Pages (1)

Clorazepate Dipotassium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d4edcb5d-dbe9-44c4-a0a9-d3b6aba4c22d", "openfda": {"unii": ["63FN7G03XY"], "rxcui": ["197464", "197465", "197466"], "spl_set_id": ["a4b80e69-b7c7-471a-8ce8-4e992808c669"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-159-10)", "package_ndc": "70954-159-10", "marketing_start_date": "20220616"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70954-159-20)", "package_ndc": "70954-159-20", "marketing_start_date": "20220701"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70954-159-30)", "package_ndc": "70954-159-30", "marketing_start_date": "20230821"}, {"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (70954-159-50)  / 1 TABLET in 1 BLISTER PACK (70954-159-40)", "package_ndc": "70954-159-50", "marketing_start_date": "20250615"}], "brand_name": "Clorazepate Dipotassium", "product_id": "70954-159_d4edcb5d-dbe9-44c4-a0a9-d3b6aba4c22d", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "70954-159", "dea_schedule": "CIV", "generic_name": "Clorazepate Dipotassium", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clorazepate Dipotassium", "active_ingredients": [{"name": "CLORAZEPATE DIPOTASSIUM", "strength": "3.75 mg/1"}], "application_number": "ANDA213730", "marketing_category": "ANDA", "marketing_start_date": "20220616", "listing_expiration_date": "20261231"}