🇺🇸
United States · US · US:0378-0277_20875d8f-5848-4892-a7fb-ab36b0288215
Chlordiazepoxide and Amitriptyline Hydrochloride
Orange BookUNIISPLATC N06AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110378027701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0277-01)
- ndc110378027705500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0277-05)
Annotations
UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A071297
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": "0378-0277_20875d8f-5848-4892-a7fb-ab36b0288215",
"productndc": "0378-0277",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "071297",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 25MG BASE;10MG",
"product_no": "001",
"approval_date": "Dec 10, 1986"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 12.5MG BASE;5MG",
"product_no": "002",
"approval_date": "Dec 10, 1986"
}
],
"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": "ANDA071297",
"marketing_category": "ANDA",
"nonproprietary_name": "chlordiazepoxide and amitriptyline hydrochloride",
"start_marketing_date": "19861210",
"active_numerator_strength": "27.98; 10"
}Related drugs
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