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Citalopram Hydrobromide 40 mg Tablet, 30-count — NDC 71205-0764-30 package photo

Citalopram Hydrobromide 40 mg Tablet, 30-count

by Proficient Rx LP · 30 TABLET in 1 BOTTLE (71205-764-30)
NDC 71205-0764-30
🏷️ FDA NDC (as labeled) 71205-764-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1027/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 71205-764-30
Product NDC 71205-764
11-digit billing NDC 71205076430
NCPDP billing unit EA — each (per item)
RxCUI 309314
UNII I1E9D14F36
UPC 0371205764302
Application # ANDA078216
SPL Set ID 4eb71151-241a-476e-a495-4a021bc55bda
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-10-18
Route ORAL
Dosage form TABLET
Substance CITALOPRAM HYDROBROMIDE
GCN Seq No 046204
GCN 16343
HICL code 010321
Ingredient (HICL) Citalopram Hydrobromide
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2S
Therapeutic class — specific (HIC3) Selective Serotonin Reuptake Inhibitor (Ssris)
AHFS code 28:16.04.20
AHFS class Selective-Serotonin Reuptake Inhibitors
FDB label name CITALOPRAM HBR 40 MG TABLET
FDB brand name Citalopram Hbr
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71205-764-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71205-0764-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin Reuptake Inhibitor class.

Pharmacologic class Serotonin Reuptake Inhibitor
Drug family (ATC) Selective serotonin reuptake inhibitors
How it works Serotonin Uptake Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderTORRENT PHARMACEUTICALS LTD
FDA applicationANDA078216 (ANDA)
Labeler code71205
First marketedOct 2007
Product typeHuman Prescription Drug
Portfolio1,723 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CITALOPRAM HBR 40 MG TABLET Ingredient Citalopram Hydrobromide
📖 What it is MedlinePlus · NLM

Citalopram is used to treat depression. Citalopram is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Antidepressants like citalopram don't work overnight — most people start to notice some improvement in mood and sleep within a few weeks, but full benefit often takes 4 to 6 weeks...
  • How long will it take before I start feeling better on citalopram?
  • You should never stop citalopram suddenly. Stopping abruptly can cause discontinuation symptoms — things like dizziness, nausea, irritability, and strange electric shock–like sensa...
  • Can I stop taking citalopram whenever I want, or do I have to taper off?
📖 Read our full Citalopram guide →
1
Nutrient depletion considerations

Citalopram may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color brown
ShapeOval
Imprint4;0;1011
Size11 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1027 $3.08 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Citalopram 40 mg 00378-6233-01 Mylan 100 tablets $0.042 AB Availability likely
Citalopram 40 mg 13668-0011-01 Torrent 100 tablets $0.042 AB Availability likely
Citalopram 40 mg 42806-0021-01 Epic 100 tablets $0.042 AB Availability likely
Citalopram Hydrobromide 40 mg 65862-0007-01 Aurobindo 100 tablets $0.042 Availability likely
Citalopram 40 mg 82009-0108-05 QUALLENT 500 tablets $0.042 AB Availability likely
Celexa 40 mg 00456-4040-01 Allergan, 100 tablets $9.464 AB Availability likely
Citalopram 40 mg 00615-8141-39 NCS 30 tablets AB FDA listed
Citalopram 40 mg 43063-0670-30 PD-Rx 30 tablets AB FDA listed
Citalopram Hydrobromide 40 mg 43353-0112-15 Aphena 15 tablets AB FDA listed
Citalopram 40 mg 50090-3136-00 A-S 30 tablets AB FDA listed
Citalopram Hydrobromide 40 mg 50090-3208-00 A-S 30 tablets AB FDA listed
Citalopram 40 mg 50090-5175-00 A-S 30 tablets AB FDA listed
Citalopram Hydrobromide 40 mg 50090-6947-00 A-S 90 tablets AB FDA listed
Citalopram 40 mg 50090-7039-00 A-S 90 tablets AB FDA listed
Citalopram 40 mg 51655-0209-26 Northwind 90 tablets AB FDA listed
Citalopram 40 mg 60429-0175-10 Golden 1000 tablets AB FDA listed
Citalopram 40 mg 63187-0140-30 Proficient 30 tablets AB FDA listed
Citalopram 40 mg 65162-0054-03 Amneal 30 tablets FDA listed
Citalopram 40 mg 67046-0113-03 Coupler 30 tablets AB FDA listed
Citalopram 40 mg 68071-3357-01 NuCare 15 tablets AB FDA listed
Citalopram Hydrobromide 40 mg 68071-3384-01 NuCare 100 tablets AB FDA listed
Citalopram 40 mg 68071-3558-01 NuCare 100 tablets AB FDA listed
Citalopram Hydrobromide 40 mg 68788-8962-01 Preferred 100 tablets AB FDA listed
Citalopram 40 mg 69097-0824-02 Cipla 30 tablets AB FDA listed
Citalopram 40 mg 70518-2228-00 REMEDYREPACK 30 tablets AB FDA listed
Citalopram 40 mg 70518-2601-00 REMEDYREPACK 90 tablets AB Discontinued
Citalopram 40 mg 70518-4334-00 REMEDYREPACK 1 tablet AB FDA listed
Citalopram Hydrobromide 40 mgthis 71205-0764-30 Proficient 30 tablets AB FDA listed
Citalopram Hydrobromide 40 mg 71335-0480-01 Bryant 30 tablets AB Discontinued
Citalopram 40 mg 71335-2232-01 Bryant 30 tablets AB FDA listed
Citalopram 40 mg 71610-0412-60 Aphena 90 tablets AB FDA listed
Citalopram 40 mg 71610-0413-60 Aphena 90 tablets AB FDA listed
Citalopram 40 mg 71610-0422-45 Aphena 45 tablets AB FDA listed
Citalopram Hydrobromide 40 mg 72657-0111-01 Glenmark 100 tablets FDA listed
Citalopram 40 mg 72789-0071-30 PD-Rx 30 tablets AB FDA listed
Citalopram Hydrobromide 40 mg 76282-0208-05 Exelan 500 tablets AB FDA listed
Citalopram 40 mg 87063-0221-01 ASCLEMED 100 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Oct 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Citalopram HBr (matched by generic name) — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Citalopram HBr. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$12.45M
Claims incl. refills
1.5M
Beneficiaries
1M
Spend / beneficiary
$12.04
Spend / claim
$8.11
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Citalopram Hydrobromide — the ingredient across all brands.

Top reported reactions

Fatigue6,992
Nausea6,019
Headache5,146
Toxicity To Various Agents5,100
Diarrhoea4,832
Fall4,463
Pain4,429

Age at onset

Neonate337
Infant60
Child54
Adolescent175
Adult8,734
Elderly4,583

Reporter sex

106,559 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization37,401
Death17,007
Life-threatening6,315
Disabling4,648
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 5,192 2,166
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71205-0764-30 You're viewing this 30 TABLET in 1 BOTTLE (71205-764-30) 2023-02-14 Active
71205-0764-60 60 TABLET in 1 BOTTLE (71205-764-60) 2023-02-14 Active
71205-0764-90 90 TABLET in 1 BOTTLE (71205-764-90) 2023-02-14 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71205-0764-30?
NDC 71205-0764-30 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 71205-0764-30 and NDC 71205-0764-60?
Both are Citalopram Hydrobromide 40 mg Tablet — the drug itself is identical. NDC 71205-0764-30 is the 30-count package, while NDC 71205-0764-60 is the 60 tablets package.
What NDC number is used to bill for this package of Citalopram Hydrobromide 40 mg Tablet?
Bill NDC 71205-0764-30 — the 11-digit billing format is 71205076430. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71205-764-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71205-0764-30, written without dashes as 71205076430. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71205-0764-30, the first segment (71205) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0764) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 tablets (71205-0764-60), 90 tablets (71205-0764-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 131 words

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short- term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . Citalopram tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] .

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning . • Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughs and behaviors ( 5.1 ) . • Citalopram tablets are not approved for use in pediatric patients ( 8.4 ) .

🎯 Indications and Usage 48 words

1 INDICATIONS AND USAGE Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ) .

⏱️ Dosage and Administration 83 words

2 DOSAGE AND ADMINISTRATION • Administer once daily with or without food ( 2 ) . • Initial dosage is 20 mg once daily; after one week may increase to maximum dosage of 40 mg once daily ( 2.1 ) . • Patients greater than 60 years of age, patients with hepatic impairment, and CYP2C19 poor metabolizers: maximum recommended dosage is 20 mg once daily ( 2.2 ) . • When discontinuing citalopram tablets, reduce dosage gradually ( 2.4 , 5.6 ) .

💊 Dosage Forms and Strengths 54 words

3 DOSAGE FORMS AND STRENGTHS Citalopram tablets, USP are available as: • 40 mg: Tan coloured, oval shaped, biconvex film coated tablets with ‘4│0’ debossed (‘4’ on left side and ‘0’ on right side of the break line) on one side and ‘1011’ on the other side Tablets: 40 mg, scored ( 3 )

Contraindications 139 words

4 CONTRAINDICATIONS Citalopram tablets are contraindicated in patients: • taking, or within 14 days of stopping, MAOIs (including MAOIs such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] . • taking pimozide because of risk of QT prolongation [see Drug Interactions ( 7 )] . • with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. Reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )] . • Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI ( 4 ) . • Concomiant use of pimozide ( 4 ) . • Known hypersensitivity to citalopram or any of the inactive ingredients of citalopram tablets ( 4 ) .

⚠️ Warnings and Cautions ~1 min read

5 WARNINGS AND PRECAUTIONS • QT-Prolongation and Torsade de Pointes: Dose-dependent QTc prolongation, Torsade de pointes, ventricular tachycardia, and sudden death have occurred. Avoid use of citalopram tablets in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the QTc interval. Monitor electrolytes in patients at high risk for hypokalemia or hypomagnesemia.

Discontinue citalopram tablets in patients with persistent QTc measurements > 500 ms ( 5.2 , 7 ) . • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If occurs, discontinue citalopram tablets and initiate supportive measures ( 5.3 ) . • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti- inflammatory drugs, other antiplatelet drugs, warfarin and other anticoagulants may increase this risk ( 5.4 ) . • Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5 ) . • Seizures: Use with caution in patients with seizure disorder ( 5.7 ) . • Angle-Closure Glaucoma: Avoid use of citalopram tablets in patients with untreated anatomically narrow angles ( 5.8 ) . • Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.9 ) . • Sexual Dysfunction: Citalopram tablets may cause symptoms of sexual dysfunction.

( 5.10 ) .

🤒 Adverse Reactions 177 words

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity reactions [see Contraindications ( 4 )] • Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions ( 5.1 )] • QT-prolongation and torsade de pointes [see Warnings and Precautions ( 5.2 )] • Serotonin syndrome [see Warnings and Precautions ( 5.3 )] • Increased risk of bleeding [see Warnings and Precautions ( 5.4 )] • Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] • Discontinuation syndrome [see Warnings and Precautions ( 5.6 )] • Seizures [see Warnings and Precautions ( 5.7 )] • Angle-closure glaucoma [see Warnings and Precautions ( 5.8 )] • Hyponatremia [see Warnings and Precautions ( 5.9 )] • Sexual Dysfunction [see Warnings and Precautions ( 5.10 )] Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 6.1 ) .

To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc . at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read

7 DRUG INTERACTIONS Table 5 presents clinically important drug interactions with citalopram. Table 5: Clinically Important Drug Interactions with Citalopram Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs, including citalopram, and MAOIs increases the risk of serotonin syndrome. Intervention Citalopram is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] .

Pimozide Clinical Impact: Concomitant use of citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of citalopram alone [see Clinical Pharmacology ( 12.2 )]. Intervention: Citalopram is contraindicated in patients taking pimozide [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. Drugs that Prolong the QTc Interval Clinical Impact: Concomitant use of citalopram with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram alone [see Clinical Pharmacology ( 12.2 )].

Intervention: Avoid concomitant use of citalopram with drugs that prolong the QT interval (citalopram is contraindicated in patients taking pimozide) [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. CYP2C19 Inhibitors Clinical Impact: Concomitant use of citalopram with CYP2C19 inhibitors increases the risk of QT prolongation and/or ventricular arrhythmias compared to the use of citalopram alone [see Clinical Pharmacology ( 12.2 )]. Intervention: The maximum recommended dosage of citalopram is 20 mg daily when used concomitantly with a CYP2C19 inhibitor [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.2 )].

Serotonergic Drugs Clinical Impact: Concomitant use of citalopram and other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during citalopram initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of citalopram and/or concomitant serotonergic drugs [see Warning and Precautions ( 5.3 )].

Drugs That Interfere With Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: Concomitant use of citalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of citalopram and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions ( 5.4 )].

CYP2C19 Inhibitors : Citalopram tablets 20 mg daily is the maximum recommended dosage for patients taking concomitant CYP2C19 inhibitors ( 5.2 , 7 ) .

👥 Use in Specific Populations 41 words

8 USE IN SPECIFIC POPULATIONS • Pregnancy: SSRI use, particularly late in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate. ( 8.1 ).

🆘 Overdosage 122 words

10 OVERDOSAGE The following have been reported with citalopram tablet overdosage: • Seizures, which may be delayed, and altered mental status including coma. • Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, and torsade de pointes. Hypertension most commonly seen, but rarely can see hypotension alone or with co‐ingestants including alcohol. • Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk).

Prolonged cardiac monitoring is recommended in citalopram overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a citalopram overdose. Consider contacting a Poison Center (1‐800‐221‐2222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology 3 words

12 CLINICAL PHARMACOLOGY

📦 How Supplied / Storage and Handling 93 words

16 HOW SUPPLIED/STORAGE AND HANDLING Citalopram Tablets, USP contain citalopram hydrobromide USP, equivalent to 40 mg citalopram base. Citalopram Tablets, USP 40 mg Bottle of 30 NDC 71205-764-30 Bottle of 60 NDC 71205-764-60 Bottle of 90 NDC 71205-764-90 Tan coloured, oval shaped, biconvex film coated tablets with ‘4│0’ debossed (‘4’ on left side and ‘0’ on right side of the break line) on one side and ‘1011’ on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 153 words

11 DESCRIPTION Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3‑dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula: The molecular formula is C 20 H 22 BrFN 2 O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder.

Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base.

The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide. image description

💬 Information for Patients ~3 min read

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning, Warnings and Precautions ( 5.1 )] . QT Prolongation and Torsade de Pointes Advise patients to consult their health care provider immediately if they feel faint, lose consciousness, or have heart palpitations.

Instruct patients to inform their health care provider that they are taking citalopram before taking any new medications [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of citalopram with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid).

Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] . Increased Risk of Bleeding Inform patients about the concomitant use of citalopram with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.4 )] .

Activation of Mania or Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.5 )] . Discontinuation Syndrome Advise patients not to abruptly discontinue citalopram and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when citalopram is discontinued [See Warnings and Precautions ( 5.6 )] .

Sexual Dysfunction Advise patients that use of citalopram may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions ( 5.10 )] . Pregnancy • Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with citalopram [see Use in Specific Populations ( 8.1 )] . • Advise patients that citalopram use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations ( 8.1 )] . • Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to citalopram during pregnancy [see Use in Specific Populations ( 8.1 )] .

Lactation Advise breastfeeding women to monitor infants for excess sedation, restlessness, agitation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations ( 8.2 )] . Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA. Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920 Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320 8088041 Revised July 2022 image description

💬 Medication Guide ~3 min read

MEDICATION GUIDE CITALOPRAM (si TAL o pram), USP (Citalopram) Tablets, for oral use What is the most important information I should know about citalopram tablets? Citalopram tablets may cause serious side effects, including: • Increased risk of suicidal thoughts and actions. Citalopram tablets and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults especially within the first few months of treatment or when the dose is changed.

Citalopram tablets are not for use in children. ° Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency medical help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling very agitated or restless • acting on dangerous impulses • trouble sleeping (insomnia) • panic attacks • acting aggressive, being angry, or violent • new or worse irritability • an extreme increase in activity or talking (mania) • other unusual changes in behavior or mood What are citalopram tablets?

Citalopram tablets are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults. It is not known if citalopram tablets are safe and effective for use in children. Who should not take citalopram tablets?

Do not take citalopram tablets if you: • take a Monoamine Oxidase Inhibitor (MAOI) • have stopped taking an MAOI in the last 14 days • are being treated with the antibiotic linezolid or intravenous methylene blue • take pimozide • are allergic to citalopram or any of the ingredients in citalopram tablets. See the end of this Medication Guide for a complete list of ingredients in citalopram tablets. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including MAOIs such as linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after you stop treatment with citalopram tablets. Before taking citalopram tablets, tell your healthcare provider about all your medical conditions, including if you: • have or have a family history of suicide, depression, bipolar disorder, mania or hypomania • have an abnormal heart rhythm called QT prolongation • have or had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome • have low potassium, magnesium, or sodium levels in your blood • have or had bleeding problems • have or had seizures (convulsions) • have high pressure in the eye (glaucoma) • have or had kidney or liver problems • are pregnant or plan to become pregnant.

Citalopram tablets may harm your unborn baby. Taking citalopram tablets late in pregnancy may lead to an increased risk of certain problems in your newborn. Talk to your healthcare provider about the risks and benefits of treating depression during pregnancy. o Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with citalopram tablets. o There is a pregnancy registry for females who are exposed to citalopram during pregnancy.

The purpose of the registry is to collect information abou…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.