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United States · US · US:71335-1256_0f092778-43f5-15d0-e063-6394a90a1215
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
- ndc117133512561100 TABLET, FILM COATED in 1 BOTTLE (71335-1256-1)
- ndc11713351256230 TABLET, FILM COATED in 1 BOTTLE (71335-1256-2)
- ndc11713351256360 TABLET, FILM COATED in 1 BOTTLE (71335-1256-3)
- ndc11713351256490 TABLET, FILM COATED in 1 BOTTLE (71335-1256-4)
- ndc11713351256520 TABLET, FILM COATED in 1 BOTTLE (71335-1256-5)
- ndc11713351256628 TABLET, FILM COATED in 1 BOTTLE (71335-1256-6)
- ndc11713351256756 TABLET, FILM COATED in 1 BOTTLE (71335-1256-7)
- ndc117133512568180 TABLET, FILM COATED in 1 BOTTLE (71335-1256-8)
Annotations
UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A089399
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": "71335-1256_0f092778-43f5-15d0-e063-6394a90a1215",
"productndc": "71335-1256",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "089399",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Jul 14, 1987"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 14, 1987"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Jul 14, 1987"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "004",
"approval_date": "Jul 14, 1987"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "005",
"approval_date": "Jul 14, 1987"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "006",
"approval_date": "Jul 14, 1987"
}
],
"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": "ANDA089399",
"marketing_category": "ANDA",
"nonproprietary_name": "Amitriptyline Hydrochloride",
"start_marketing_date": "19870714",
"active_numerator_strength": "50"
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