Imipramine Hydrochloride

Orange BookUNIISPLATC N06AA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN06AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
8280495800
100 TABLET in 1 BOTTLE (82804-958-00)
ndc11
8280495811
1000 TABLET in 1 BOTTLE (82804-958-11)
ndc11
8280495830
30 TABLET in 1 BOTTLE (82804-958-30)
ndc11
8280495855
500 TABLET in 1 BOTTLE (82804-958-55)
ndc11
8280495860
60 TABLET in 1 BOTTLE (82804-958-60)
ndc11
8280495872
120 TABLET in 1 BOTTLE (82804-958-72)
ndc11
8280495890
90 TABLET in 1 BOTTLE (82804-958-90)

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": "82804-958_5997822f-ce83-4091-be71-21a6b01caaba",
  "productndc": "82804-958",
  "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": "50"
}

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