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United States · US · US:71335-2769_f4fd7181-a56a-4f52-9b9f-0995f5806229
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
- ndc117133527690120 TABLET, COATED in 1 BOTTLE (71335-2769-0)
- ndc11713352769120 TABLET, COATED in 1 BOTTLE (71335-2769-1)
- ndc11713352769230 TABLET, COATED in 1 BOTTLE (71335-2769-2)
- ndc117133527693100 TABLET, COATED in 1 BOTTLE (71335-2769-3)
- ndc11713352769460 TABLET, COATED in 1 BOTTLE (71335-2769-4)
- ndc11713352769550 TABLET, COATED in 1 BOTTLE (71335-2769-5)
- ndc11713352769690 TABLET, COATED in 1 BOTTLE (71335-2769-6)
- ndc11713352769745 TABLET, COATED in 1 BOTTLE (71335-2769-7)
- ndc11713352769828 TABLET, COATED in 1 BOTTLE (71335-2769-8)
- ndc11713352769956 TABLET, COATED in 1 BOTTLE (71335-2769-9)
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": "71335-2769_f4fd7181-a56a-4f52-9b9f-0995f5806229",
"productndc": "71335-2769",
"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": "25"
}Related drugs
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