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United States · US · US:71335-2802_b24ae4bb-d299-4a13-9cbe-6568dc4090cd
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 · 8
- ndc117133528021100 TABLET, COATED in 1 BOTTLE (71335-2802-1)
- ndc11713352802230 TABLET, COATED in 1 BOTTLE (71335-2802-2)
- ndc11713352802360 TABLET, COATED in 1 BOTTLE (71335-2802-3)
- ndc11713352802490 TABLET, COATED in 1 BOTTLE (71335-2802-4)
- ndc11713352802520 TABLET, COATED in 1 BOTTLE (71335-2802-5)
- ndc11713352802628 TABLET, COATED in 1 BOTTLE (71335-2802-6)
- ndc11713352802756 TABLET, COATED in 1 BOTTLE (71335-2802-7)
- ndc117133528028180 TABLET, COATED in 1 BOTTLE (71335-2802-8)
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": "71335-2802_b24ae4bb-d299-4a13-9cbe-6568dc4090cd",
"productndc": "71335-2802",
"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": "50"
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