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United States · US · US:72789-243_4d50ea03-67e1-10a9-e063-6394a90ae03c

Imipramine Hydrochloride

Orange BookUNIISPLATC N06AA02

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7278924301
    100 TABLET in 1 BOTTLE, PLASTIC (72789-243-01)
  • ndc11
    7278924395
    1000 TABLET in 1 BOTTLE, PLASTIC (72789-243-95)

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": "72789-243_4d50ea03-67e1-10a9-e063-6394a90ae03c",
  "productndc": "72789-243",
  "dosage_form": "TABLET",
  "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": "20200801",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code N06AA02.

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