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United States · US · US:65862-005_5642ea11-17b4-431a-a896-2cb336929100

Citalopram

Orange BookUNIISPLATC N06AB04

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN06AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6586200501
    100 TABLET, FILM COATED in 1 BOTTLE (65862-005-01)
  • ndc11
    6586200505
    500 TABLET, FILM COATED in 1 BOTTLE (65862-005-05)
  • ndc11
    6586200510
    10 BLISTER PACK in 1 CARTON (65862-005-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6586200530
    30 TABLET, FILM COATED in 1 BOTTLE (65862-005-30)
  • ndc11
    6586200532
    30 TABLET, FILM COATED in 1 BLISTER PACK (65862-005-32)
  • ndc11
    6586200560
    60 TABLET, FILM COATED in 1 BOTTLE (65862-005-60)
  • ndc11
    6586200590
    90 TABLET, FILM COATED in 1 BOTTLE (65862-005-90)

Annotations

UNII (FDA Substance ID)
I1E9D14F36
CITALOPRAM HYDROBROMIDE
RxCUI 221078
Orange Book
A077031
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": "65862-005_5642ea11-17b4-431a-a896-2cb336929100",
  "productndc": "65862-005",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077031",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Oct 28, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Oct 28, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Oct 28, 2004"
      }
    ],
    "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": "ANDA077031",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Citalopram Hydrobromide",
  "start_marketing_date": "20041028",
  "active_numerator_strength": "10"
}

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