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United States · US · US:70710-1226_5160111f-8889-4057-aa2a-519eccd14a5e
Amitriptyline Hydrochloride
Orange BookUNIISPLATC N06AA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN06AA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170710122601000 TABLET, FILM COATED in 1 BOTTLE (70710-1226-0)
- ndc117071012261100 TABLET, FILM COATED in 1 BOTTLE (70710-1226-1)
Annotations
UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A210086
ABABABABABAB
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": {
"ce87013b-bf4a-47d1-9808-7cb8290feb23": {
"match": "brand_token",
"title": "AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [REMEDYREPACK INC.]",
"spl_version": "5",
"published_date": "2026-05-04"
}
},
"productid": "70710-1226_5160111f-8889-4057-aa2a-519eccd14a5e",
"productndc": "70710-1226",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210086",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 6, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Oct 6, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Oct 6, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "004",
"approval_date": "Oct 6, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "005",
"approval_date": "Oct 6, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "006",
"approval_date": "Oct 6, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMITRIPTYLINE HYDROCHLORIDE",
"proprietary_name": "Amitriptyline Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210086",
"marketing_category": "ANDA",
"nonproprietary_name": "Amitriptyline Hydrochloride",
"start_marketing_date": "20171226",
"active_numerator_strength": "25"
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