🇺🇸
United States · US · US:60219-1677_4c4923d9-915c-441a-90ee-fca641301d6e
chlordiazepoxide hydrochloride and clidinium bromide
Orange BookUNIISPLATC N05BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeN05BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116021916771100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1677-1)
Annotations
UNII (FDA Substance ID)
MFM6K1XWDK
CHLORDIAZEPOXIDE HYDROCHLORIDE
RxCUI 203173
Orange Book
A215555
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "MFM6K1XWDK",
"rxcui": "203173",
"inchikey": "DMLFJMQTNDSRFU-UHFFFAOYSA-N",
"display_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"511264f5-024b-350a-e063-6394a90a51e9": {
"match": "brand_token",
"title": "CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [COUPER LLC]",
"spl_version": "1",
"published_date": "2026-05-07"
}
},
"productid": "60219-1677_4c4923d9-915c-441a-90ee-fca641301d6e",
"productndc": "60219-1677",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215555",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG;2.5MG",
"product_no": "001",
"approval_date": "Oct 25, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE",
"proprietary_name": "chlordiazepoxide hydrochloride and clidinium bromide",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA215555",
"marketing_category": "ANDA",
"nonproprietary_name": "chlordiazepoxide hydrochloride and clidinium bromide",
"start_marketing_date": "20211025",
"active_numerator_strength": "5; 2.5"
}Related drugs
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