clorazepate dipotassium

Generic: clorazepate dipotassium

Labeler: aurolife pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clorazepate dipotassium
Generic Name clorazepate dipotassium
Labeler aurolife pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clorazepate dipotassium 3.75 mg/1

Manufacturer
Aurolife Pharma LLC

Identifiers & Regulatory

Product NDC 13107-282
Product ID 13107-282_69451c35-dd9a-4690-8d5e-4dcfa8837620
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071858
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-09-23

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107282
Hyphenated Format 13107-282

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 ANDA071858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-282-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (13107-282-05)
source: ndc

Packages (2)

13107-282-01 100 TABLET in 1 BOTTLE (13107-282-01) 13107-282-05 500 TABLET in 1 BOTTLE, PLASTIC (13107-282-05)

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": "69451c35-dd9a-4690-8d5e-4dcfa8837620", "openfda": {"unii": ["63FN7G03XY"], "rxcui": ["197464", "197465", "197466"], "spl_set_id": ["69451c35-dd9a-4690-8d5e-4dcfa8837620"], "manufacturer_name": ["Aurolife Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-282-01)", "package_ndc": "13107-282-01", "marketing_start_date": "20230923"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (13107-282-05)", "package_ndc": "13107-282-05", "marketing_start_date": "20230923"}], "brand_name": "CLORAZEPATE DIPOTASSIUM", "product_id": "13107-282_69451c35-dd9a-4690-8d5e-4dcfa8837620", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "13107-282", "dea_schedule": "CIV", "generic_name": "CLORAZEPATE DIPOTASSIUM", "labeler_name": "Aurolife Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLORAZEPATE DIPOTASSIUM", "active_ingredients": [{"name": "CLORAZEPATE DIPOTASSIUM", "strength": "3.75 mg/1"}], "application_number": "ANDA071858", "marketing_category": "ANDA", "marketing_start_date": "20230923", "listing_expiration_date": "20261231"}