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United States · US · US:68788-9692_543a6dbf-f42d-4bc1-ad77-9ceac5e6bfe9

Citalopram Hydrobromide

Orange BookUNIISPLATC N06AB04

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

Identification

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

Packs · 5

  • ndc11
    6878896921
    100 TABLET, FILM COATED in 1 BOTTLE (68788-9692-1)
  • ndc11
    6878896923
    30 TABLET, FILM COATED in 1 BOTTLE (68788-9692-3)
  • ndc11
    6878896926
    60 TABLET, FILM COATED in 1 BOTTLE (68788-9692-6)
  • ndc11
    6878896928
    120 TABLET, FILM COATED in 1 BOTTLE (68788-9692-8)
  • ndc11
    6878896929
    90 TABLET, FILM COATED in 1 BOTTLE (68788-9692-9)

Annotations

UNII (FDA Substance ID)
I1E9D14F36
CITALOPRAM HYDROBROMIDE
RxCUI 221078
Orange Book
A078216
ABABAB
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": "68788-9692_543a6dbf-f42d-4bc1-ad77-9ceac5e6bfe9",
  "productndc": "68788-9692",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078216",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Mar 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Mar 27, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CITALOPRAM HYDROBROMIDE",
  "proprietary_name": "Citalopram Hydrobromide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078216",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Citalopram Hydrobromide",
  "start_marketing_date": "20130326",
  "active_numerator_strength": "10"
}

Related drugs

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