Clomipramine hydrochloride

Orange BookUNIISPLATC N06AA04

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

Identification

ManufacturerAjanta Pharma USA Inc.

CountryUS (United States)

ATC codeN06AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2724121001
100 CAPSULE in 1 BOTTLE (27241-210-01)
ndc11
2724121030
30 CAPSULE in 1 BOTTLE (27241-210-30)

Annotations

UNII (FDA Substance ID)

2LXW0L6GWJ

CLOMIPRAMINE HYDROCHLORIDE

RxCUI 81984

Orange Book

A213897

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": "27241-210_a0384dc3-9ab1-4632-bbb8-4e84e0a6a2e8",
  "productndc": "27241-210",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213897",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Oct 2, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Oct 2, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Oct 2, 2020"
      }
    ],
    "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": "ANDA213897",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clomipramine hydrochloride",
  "start_marketing_date": "20201223",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code N06AA04.

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