🇺🇸
United States · US · US:71335-3007_38ed32d4-0f8d-491c-8c67-7b38d7d72513
Amitriptyline Hydrochloride
Orange BookUNIISPLATC N06AA09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN06AA09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc117133530070100 TABLET, COATED in 1 BOTTLE (71335-3007-0)
- ndc11713353007130 TABLET, COATED in 1 BOTTLE (71335-3007-1)
- ndc11713353007215 TABLET, COATED in 1 BOTTLE (71335-3007-2)
- ndc11713353007360 TABLET, COATED in 1 BOTTLE (71335-3007-3)
- ndc11713353007490 TABLET, COATED in 1 BOTTLE (71335-3007-4)
- ndc11713353007528 TABLET, COATED in 1 BOTTLE (71335-3007-5)
- ndc117133530076120 TABLET, COATED in 1 BOTTLE (71335-3007-6)
- ndc11713353007750 TABLET, COATED in 1 BOTTLE (71335-3007-7)
- ndc117133530078180 TABLET, COATED in 1 BOTTLE (71335-3007-8)
- ndc1171335300796 TABLET, COATED in 1 BOTTLE (71335-3007-9)
Annotations
UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A212654
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": "71335-3007_38ed32d4-0f8d-491c-8c67-7b38d7d72513",
"productndc": "71335-3007",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "212654",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Apr 7, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Sep 29, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Sep 29, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "004",
"approval_date": "Sep 29, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "005",
"approval_date": "Sep 29, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "006",
"approval_date": "Sep 29, 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": "ANDA212654",
"marketing_category": "ANDA",
"nonproprietary_name": "Amitriptyline Hydrochloride",
"start_marketing_date": "20240520",
"active_numerator_strength": "10"
}Related drugs
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