🇺🇸
United States · US · US:29300-419_3f6bcdb5-c8ad-45c0-b43f-2dbea8980376
Amitriptyline Hydrochloride
Orange BookUNIISPLATC N06AA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeN06AA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc112930041901100 TABLET, FILM COATED in 1 BOTTLE (29300-419-01)
- ndc112930041905500 TABLET, FILM COATED in 1 BOTTLE (29300-419-05)
- ndc1129300419101000 TABLET, FILM COATED in 1 BOTTLE (29300-419-10)
Annotations
UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A214548
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": "29300-419_3f6bcdb5-c8ad-45c0-b43f-2dbea8980376",
"productndc": "29300-419",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214548",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "May 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "May 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "004",
"approval_date": "May 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "005",
"approval_date": "May 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "006",
"approval_date": "May 19, 2021"
}
],
"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": "ANDA214548",
"marketing_category": "ANDA",
"nonproprietary_name": "Amitriptyline Hydrochloride",
"start_marketing_date": "20210526",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AA09.
- 🇮🇹ADEPRIL*30 cpr rivestite 10 mgTEOFARMA Srl
- 🇮🇹ADEPRIL*30 cpr rivestite 25 mgTEOFARMA Srl
- 🇪🇸AMITRIPTILINA HIDROCLORURO NEURAXPHARM 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGNeuraxpharm Spain S.L.
- 🇪🇸AMITRIPTILINA HIDROCLORURO NEURAXPHARM 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGNeuraxpharm Spain S.L.
- 🇪🇸AMITRIPTILINA HIDROCLORURO NEURAXPHARM 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGNeuraxpharm Spain S.L.
- 🇪🇸AMITRIPTILINA HIDROCLORURO NEURAXPHARM 75 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGNeuraxpharm Spain S.L.
- 🇪🇸AMITRIPTILINA HIDROCLORURO TARBIS 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGTarbis Farma S.L.
- 🇪🇸AMITRIPTILINA HIDROCLORURO TARBIS 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGTarbis Farma S.L.
Access this data programmatically
Query Amitriptyline Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.