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United States · US · US:80425-0342_2a9c2eb6-a6db-f647-e063-6294a90a93fe

Imipramine Hydrochloride

Orange BookUNIISPLATC N06AA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeN06AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8042503421
    30 TABLET, FILM COATED in 1 BOTTLE (80425-0342-1)
  • ndc11
    8042503422
    60 TABLET, FILM COATED in 1 BOTTLE (80425-0342-2)
  • ndc11
    8042503423
    90 TABLET, FILM COATED in 1 BOTTLE (80425-0342-3)

Annotations

UNII (FDA Substance ID)
BKE5Q1J60U
IMIPRAMINE HYDROCHLORIDE
RxCUI 150816
Orange Book
A040751
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": "80425-0342_2a9c2eb6-a6db-f647-e063-6294a90a93fe",
  "productndc": "80425-0342",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "040751",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Feb 28, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Feb 28, 2008"
      }
    ],
    "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": "ANDA040751",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Imipramine Hydrochloride",
  "start_marketing_date": "20230606",
  "active_numerator_strength": "25"
}

Related drugs

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