🇺🇸
United States · US · US:42571-302_3747026e-d9b9-7fb3-e063-6394a90a1641
Chlordiazepoxide and Amitriptyline Hydrochloride
Orange BookUNIISPLATC N06AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeN06AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114257130201100 TABLET in 1 BOTTLE (42571-302-01)
- ndc114257130205500 TABLET in 1 BOTTLE (42571-302-05)
Annotations
UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A211925
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "26LUD4JO9K",
"rxcui": "203168",
"inchikey": "KFYRPLNVJVHZGT-UHFFFAOYSA-N",
"display_name": "AMITRIPTYLINE 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": "42571-302_3747026e-d9b9-7fb3-e063-6394a90a1641",
"productndc": "42571-302",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211925",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 12.5MG BASE;5MG",
"product_no": "001",
"approval_date": "Feb 2, 2022"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 25MG BASE;10MG",
"product_no": "002",
"approval_date": "Feb 2, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE",
"proprietary_name": "Chlordiazepoxide and Amitriptyline Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA211925",
"marketing_category": "ANDA",
"nonproprietary_name": "Chlordiazepoxide and Amitriptyline Hydrochloride",
"start_marketing_date": "20220401",
"active_numerator_strength": "5; 12.5"
}Related drugs
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