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United States · US · US:0054-0062_6a701183-6c4f-448f-a05a-81ee7f5b734f

Citalopram

Orange BookUNIISPLATC N06AB04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN06AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0054006258
    1 BOTTLE, PLASTIC in 1 CARTON (0054-0062-58) / 240 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
I1E9D14F36
CITALOPRAM HYDROBROMIDE
RxCUI 221078
Orange Book
A077043
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "I1E9D14F36",
    "rxcui": "221078",
    "inchikey": "WIHMBLDNRMIGDW-UHFFFAOYSA-N",
    "display_name": "CITALOPRAM HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "df8db06a-ced7-4dd6-83bd-c61d2f68f1b1": {
      "match": "brand_token",
      "title": "CITALOPRAM TABLET, FILM COATED [ASCLEMED USA INC.]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0054-0062_6a701183-6c4f-448f-a05a-81ee7f5b734f",
  "productndc": "0054-0062",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "077043",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 10MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Dec 13, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CITALOPRAM HYDROBROMIDE",
  "proprietary_name": "Citalopram",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA077043",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Citalopram",
  "start_marketing_date": "20040525",
  "active_numerator_strength": "10"
}

Related drugs

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