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United States · US · US:70868-810_241442d6-33bd-74fe-e063-6394a90a0a49

Imipramine Hydrochloride

Orange BookUNIISPLATC N06AA02

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

Identification

ManufacturerKey Therapeutics
CountryUS (United States)
ATC codeN06AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7086881010
    100 TABLET, FILM COATED in 1 BOTTLE (70868-810-10)

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": "70868-810_241442d6-33bd-74fe-e063-6394a90a0a49",
  "productndc": "70868-810",
  "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": "20220718",
  "active_numerator_strength": "25"
}

Related drugs

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