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United States · US · US:71335-1254_0f092467-7f36-1cb2-e063-6394a90a88a2
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
- ndc117133512540120 TABLET, FILM COATED in 1 BOTTLE (71335-1254-0)
- ndc11713351254120 TABLET, FILM COATED in 1 BOTTLE (71335-1254-1)
- ndc11713351254230 TABLET, FILM COATED in 1 BOTTLE (71335-1254-2)
- ndc117133512543100 TABLET, FILM COATED in 1 BOTTLE (71335-1254-3)
- ndc11713351254460 TABLET, FILM COATED in 1 BOTTLE (71335-1254-4)
- ndc11713351254550 TABLET, FILM COATED in 1 BOTTLE (71335-1254-5)
- ndc11713351254690 TABLET, FILM COATED in 1 BOTTLE (71335-1254-6)
- ndc11713351254745 TABLET, FILM COATED in 1 BOTTLE (71335-1254-7)
- ndc11713351254828 TABLET, FILM COATED in 1 BOTTLE (71335-1254-8)
- ndc11713351254956 TABLET, FILM COATED in 1 BOTTLE (71335-1254-9)
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": "71335-1254_0f092467-7f36-1cb2-e063-6394a90a88a2",
"productndc": "71335-1254",
"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": "25"
}Related drugs
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