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United States · US · US:69315-133_2fbbe85e-9a5e-45af-bea7-e2b7ef240d3f
Imipramine Hydrochloride
Orange BookUNIISPLATC N06AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeN06AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116931513301100 TABLET, FILM COATED in 1 BOTTLE (69315-133-01)
- ndc1169315133101000 TABLET, FILM COATED in 1 BOTTLE (69315-133-10)
Annotations
UNII (FDA Substance ID)
BKE5Q1J60U
IMIPRAMINE HYDROCHLORIDE
RxCUI 150816
Orange Book
A040903
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BKE5Q1J60U",
"rxcui": "150816",
"inchikey": "XZZXIYZZBJDEEP-UHFFFAOYSA-N",
"display_name": "IMIPRAMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"02c19a0a-3d9d-4881-ad14-1687aafd87b5": {
"match": "brand_token",
"title": "IMIPRAMINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]",
"spl_version": "5",
"published_date": "2026-04-14"
}
},
"productid": "69315-133_2fbbe85e-9a5e-45af-bea7-e2b7ef240d3f",
"productndc": "69315-133",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "040903",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 24, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Oct 24, 2012"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "003",
"approval_date": "Oct 24, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IMIPRAMINE HYDROCHLORIDE",
"proprietary_name": "Imipramine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040903",
"marketing_category": "ANDA",
"nonproprietary_name": "Imipramine Hydrochloride",
"start_marketing_date": "20160407",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AA02.
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