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United States · US · US:65162-054_a42ab6f8-0664-4d9d-9da0-116bba7e55fc

Citalopram

Orange BookUNIISPLATC N06AB04

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN06AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6516205403
    30 TABLET in 1 BOTTLE (65162-054-03)
  • ndc11
    6516205410
    100 TABLET in 1 BOTTLE (65162-054-10)
  • ndc11
    6516205411
    1000 TABLET in 1 BOTTLE (65162-054-11)
  • ndc11
    6516205450
    500 TABLET in 1 BOTTLE (65162-054-50)

Annotations

UNII (FDA Substance ID)
I1E9D14F36
CITALOPRAM HYDROBROMIDE
RxCUI 221078
Orange Book
A077289
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": "65162-054_a42ab6f8-0664-4d9d-9da0-116bba7e55fc",
  "productndc": "65162-054",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077289",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Nov 30, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Nov 30, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Nov 30, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CITALOPRAM HYDROBROMIDE",
  "proprietary_name": "Citalopram",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077289",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Citalopram",
  "start_marketing_date": "20100406",
  "active_numerator_strength": "40"
}

Related drugs

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