🇺🇸
United States · US · US:70954-158_d4edcb5d-dbe9-44c4-a0a9-d3b6aba4c22d
Clorazepate Dipotassium
Orange BookUNIISPLATC N05BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117095415810100 TABLET in 1 BOTTLE (70954-158-10)
- ndc117095415820500 TABLET in 1 BOTTLE (70954-158-20)
- ndc11709541583030 TABLET in 1 BOTTLE (70954-158-30)
- ndc11709541585030 BLISTER PACK in 1 BOX, UNIT-DOSE (70954-158-50) / 1 TABLET in 1 BLISTER PACK (70954-158-40)
Annotations
UNII (FDA Substance ID)
63FN7G03XY
CLORAZEPATE DIPOTASSIUM
RxCUI 2607
Orange Book
A213730
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "63FN7G03XY",
"rxcui": "2607",
"inchikey": "QCHSEDTUUKDTIG-UHFFFAOYSA-L",
"display_name": "CLORAZEPATE DIPOTASSIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"919cbd07-f587-4005-acff-26213dd1d1fb": {
"match": "brand_token",
"title": "CLORAZEPATE DIPOTASSIUM TABLET [AUROLIFE PHARMA LLC]",
"spl_version": "5",
"published_date": "2026-03-26"
}
},
"productid": "70954-158_d4edcb5d-dbe9-44c4-a0a9-d3b6aba4c22d",
"productndc": "70954-158",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213730",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3.75MG",
"product_no": "001",
"approval_date": "Jun 16, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "7.5MG",
"product_no": "002",
"approval_date": "Jun 16, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Dec 16, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLORAZEPATE DIPOTASSIUM",
"proprietary_name": "Clorazepate Dipotassium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213730",
"marketing_category": "ANDA",
"nonproprietary_name": "Clorazepate Dipotassium",
"start_marketing_date": "20220616",
"active_numerator_strength": "7.5"
}Related drugs
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