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United States · US · US:71335-2397_59d04648-11e9-482b-90e7-d31d6e8703c5
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
- ndc117133523970120 TABLET in 1 BOTTLE (71335-2397-0)
- ndc11713352397120 TABLET in 1 BOTTLE (71335-2397-1)
- ndc11713352397230 TABLET in 1 BOTTLE (71335-2397-2)
- ndc117133523973100 TABLET in 1 BOTTLE (71335-2397-3)
- ndc11713352397460 TABLET in 1 BOTTLE (71335-2397-4)
- ndc11713352397550 TABLET in 1 BOTTLE (71335-2397-5)
- ndc11713352397690 TABLET in 1 BOTTLE (71335-2397-6)
- ndc11713352397745 TABLET in 1 BOTTLE (71335-2397-7)
- ndc11713352397828 TABLET in 1 BOTTLE (71335-2397-8)
- ndc11713352397956 TABLET in 1 BOTTLE (71335-2397-9)
Annotations
UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A217411
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": "71335-2397_59d04648-11e9-482b-90e7-d31d6e8703c5",
"productndc": "71335-2397",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217411",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 19, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "May 19, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "May 19, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "004",
"approval_date": "May 19, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "005",
"approval_date": "May 19, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "006",
"approval_date": "May 19, 2023"
}
],
"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": "ANDA217411",
"marketing_category": "ANDA",
"nonproprietary_name": "Amitriptyline Hydrochloride",
"start_marketing_date": "20230610",
"active_numerator_strength": "25"
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