Clomipramine Hydrochloride

Orange BookUNIISPLATC N06AA04

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN06AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6818049301
100 CAPSULE in 1 BOTTLE (68180-493-01)

Annotations

UNII (FDA Substance ID)

2LXW0L6GWJ

CLOMIPRAMINE HYDROCHLORIDE

RxCUI 81984

Orange Book

A209294

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2LXW0L6GWJ",
    "rxcui": "81984",
    "inchikey": "WIMWMKZEIBHDTH-UHFFFAOYSA-N",
    "display_name": "CLOMIPRAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c33d02b1-9a00-4b4a-8f8e-d2679c3838bc": {
      "match": "brand_token",
      "title": "CLOMIPRAMINE HCL POWDER [AX PHARMACEUTICAL CORP]",
      "spl_version": "1",
      "published_date": "2026-04-14"
    }
  },
  "productid": "68180-493_7e89336a-0de0-42d6-af70-26345940b81d",
  "productndc": "68180-493",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209294",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 21, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Nov 21, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOMIPRAMINE HYDROCHLORIDE",
  "proprietary_name": "Clomipramine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209294",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clomipramine Hydrochloride Capsules",
  "start_marketing_date": "20190204",
  "active_numerator_strength": "50"
}

Related drugs

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