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United States · US · US:68180-313_b891d3a3-3346-441e-99cc-03528b4afa46

Imipramine Hydrochloride

Orange BookUNIISPLATC N06AA02

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

Identification

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

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
BKE5Q1J60U
IMIPRAMINE HYDROCHLORIDE
RxCUI 150816
Orange Book
A090441
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": "68180-313_b891d3a3-3346-441e-99cc-03528b4afa46",
  "productndc": "68180-313",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090441",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 11, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 11, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Mar 11, 2010"
      }
    ],
    "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": "ANDA090441",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Imipramine Hydrochloride",
  "start_marketing_date": "20101221",
  "active_numerator_strength": "50"
}

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