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United States · US · US:71205-911_be10b430-6ed9-4241-b6d9-818846e80839

Clomipramine Hydrochloride

Orange BookUNIISPLATC N06AA04

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN06AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7120591100
    100 CAPSULE in 1 BOTTLE (71205-911-00)
  • ndc11
    7120591111
    1000 CAPSULE in 1 BOTTLE (71205-911-11)
  • ndc11
    7120591130
    30 CAPSULE in 1 BOTTLE (71205-911-30)
  • ndc11
    7120591155
    500 CAPSULE in 1 BOTTLE (71205-911-55)
  • ndc11
    7120591160
    60 CAPSULE in 1 BOTTLE (71205-911-60)
  • ndc11
    7120591190
    90 CAPSULE in 1 BOTTLE (71205-911-90)

Annotations

UNII (FDA Substance ID)
2LXW0L6GWJ
CLOMIPRAMINE HYDROCHLORIDE
RxCUI 81984
Orange Book
A211364
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": "71205-911_be10b430-6ed9-4241-b6d9-818846e80839",
  "productndc": "71205-911",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211364",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Feb 7, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Feb 7, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Feb 7, 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": "ANDA211364",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clomipramine Hydrochloride",
  "start_marketing_date": "20200310",
  "active_numerator_strength": "50"
}

Related drugs

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