Citalopram

Orange BookUNIISPLATC N06AB04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerASCLEMED USA INC.

CountryUS (United States)

ATC codeN06AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
8706321901
100 TABLET, FILM COATED in 1 BOTTLE (87063-219-01)
ndc11
8706321910
10 TABLET, FILM COATED in 1 BOTTLE (87063-219-10)
ndc11
8706321920
20 TABLET, FILM COATED in 1 BOTTLE (87063-219-20)
ndc11
8706321930
30 TABLET, FILM COATED in 1 BOTTLE (87063-219-30)
ndc11
8706321960
60 TABLET, FILM COATED in 1 BOTTLE (87063-219-60)
ndc11
8706321990
90 TABLET, FILM COATED in 1 BOTTLE (87063-219-90)

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": "87063-219_52ee1af5-9a84-797c-e063-6294a90ab63d",
  "productndc": "87063-219",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078216",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Citalopram",
  "start_marketing_date": "20071018",
  "active_numerator_strength": "10"
}

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