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Mirtazapine 15 mg Tablet, Film Coated, 60-count — NDC 61919-153-60 (Billing 61919-0153-60)

by Direct_Rx · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Mirtazapine 15 mg Tablet, Film Coated from Direct_Rx, marketed since May 2022 and currently FDA-listed. It is this product's only package size.

NDC 61919-0153-60
🏷️ FDA NDC (as labeled) 61919-153-60 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 61919-153-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61919 labeler · 153 product · 60 package
Package marketed since
May 10, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
60 EA per package
Barcode (UPC-A, from the NDC)
3 6191915360 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61919-153-60
Product NDC 61919-153
11-digit billing NDC 61919015360
NCPDP billing unit EA — each (per item)
RxCUI 311725
UNII A051Q2099Q
Application # ANDA077666
SPL Set ID dea8c09a-b759-1da7-e053-2a95a90a3346
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-10
Route ORAL
Dosage form TABLET, FILM COATED
Substance MIRTAZAPINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 58030050000315
GPI class Mirtazapine
GCN Seq No 046450
GCN 16732
HICL code 011505
Ingredient (HICL) Mirtazapine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7B
Therapeutic class — specific (HIC3) Alpha-2 Receptor Antagonist Antidepressants
AHFS code 28:16.04.24
AHFS class Serotonin Modulators
FDB label name MIRTAZAPINE 15 MG TABLET
FDB brand name Mirtazapine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 046450
  • GCN: 16732
  • GPI-14 (Medi-Span): 58030050000315
  • HICL (First Databank): 011505
  • AHFS class code: 28:16.04.24
  • RxCUI (RxNorm): 311725
Why two NDCs? The FDA registers this code as 61919-153-60 — 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 → 61919-0153-60. 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 Other antidepressants class.

Drug family (ATC) Other antidepressants
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.

Clinical

Label name MIRTAZAPINE 15 MG TABLET Ingredient Mirtazapine
📗 Our plain-language guide HelloPharmacist
  • It treats major depressive disorder (MDD) in adults. It's an antidepressant that may raise norepinephrine and serotonin activity in the brain. Your prescriber will check over time...
  • Most people take it once a day, preferably in the evening before bed, since it commonly causes sleepiness. Food doesn't change how well it's absorbed. Follow your prescriber's dire...
  • When should I take it, and does food matter?
  • Sleepiness is the big one, along with dry mouth, increased appetite, weight gain, constipation, and dizziness. Be careful driving until you know how it affects you. Call your docto...
📖 Read our full Mirtazapine guide →
1
Nutrient depletion considerations

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

🧪 Full Mirtazapine nutrient depletion report →
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.

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 $0.6699 $40.19 / 60 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61919-0153-60 You're viewing this Main listing 60 TABLET, FILM COATED in 1 BOTTLE 2022-05-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mirtazapine 15 mg 00378-3515-01 Mylan 100 tablets $0.063 AB Availability likely —
Mirtazapine 15 mg 00904-6519-61 Major 1 tablet $0.063 AB Availability likely —
Mirtazapine 15 mg 51079-0086-20 Mylan 1 tablet $0.063 AB Availability likely —
Mirtazapine 15 mg 57237-0008-05 Rising 500 tablets $0.063 AB Availability likely —
Mirtazapine 15 mg 57664-0499-18 Sun 1000 tablets $0.063 AB Availability likely —
Mirtazapine 15 mg 60505-0247-01 Apotex 30 tablets $0.063 AB Availability likely —
Mirtazapine 15 mg 63739-0098-10 McKesson 10 tablets $0.063 AB Availability likely —
Mirtazapine 15 mg 66993-0607-04 Prasco 500 tablets $0.063 AB Availability likely —
Mirtazapine 15 mg 68084-0119-01 American 1 tablet $0.063 AB Availability likely —
Remeron 15 mg 78206-0160-01 Organon 30 tablets $6.363 AB Availability likely —
Mirtazapine 15 mg 00615-8268-05 NCS 15 tablets — AB FDA listed —
Mirtazapine 15 mg 13107-0031-01 Aurolife 100 tablets — AB FDA listed —
mirtazapine 15 mg 31722-0408-05 Camber 500 tablets — AB FDA listed —
Mirtazapine 15 mg 48433-0076-20 Safecor 1 tablet — AB FDA listed —
Mirtazapine 15 mg 50090-2140-00 A-S 30 tablets — AB FDA listed —
Mirtazapine 15 mg 50090-2800-00 A-S 30 tablets — AB FDA listed —
Mirtazapine 15 mg 51407-0350-10 Golden 1000 tablets — AB FDA listed —
Mirtazapine 15 mg 55154-5355-00 Cardinal 1 tablet — AB FDA listed —
Mirtazapine 15 mg 55154-7297-00 Cardinal 1 tablet — AB FDA listed —
Mirtazapine 15 mgthis 61919-0153-60 Direct_Rx 60 tablets — AB FDA listed —
Mirtazapine 15 mg 63187-0206-30 Proficient 30 tablets — AB FDA listed —
Mirtazapine 15 mg 63629-2366-01 Bryant 1000 tablets — AB FDA listed —
Mirtazapine 15 mg 63629-2367-01 Bryant 30 tablets — AB FDA listed —
Mirtazapine 15 mg 65862-0031-01 Aurobindo 100 tablets — AB FDA listed —
Mirtazapine 15 mg 67046-1590-03 Coupler 30 tablets — AB FDA listed —
Mirtazapine 15 mg 68788-7251-01 Preferred 15 tablets — AB FDA listed —
Mirtazapine 15 mg 70518-0180-00 REMEDYREPACK 30 tablets — AB FDA listed —
Mirtazapine 15 mg 70518-1397-00 REMEDYREPACK 30 tablets — AB FDA listed —
Mirtazapine 15 mg 70518-1838-00 REMEDYREPACK 30 tablets — AB FDA listed —
Mirtazapine 15 mg 70518-2453-00 REMEDYREPACK 30 tablets — AB FDA listed —
Mirtazapine 15 mg 70518-4322-00 REMEDYREPACK 30 tablets — AB FDA listed —
Mirtazapine 15 mg 71205-0481-30 Proficient 30 tablets — AB FDA listed —
Mirtazapine 15 mg 71335-0286-01 Bryant 30 tablets — AB FDA listed —
Mirtazapine 15 mg 71335-0664-01 Bryant 30 tablets — AB FDA listed —
Mirtazapine 15 mg 71335-1055-01 Bryant 30 tablets — AB Discontinued —
Mirtazapine 15 mg 71610-0115-15 Aphena 15 tablets — AB FDA listed —
Mirtazapine 15 mg 71610-0475-15 Aphena 15 tablets — AB FDA listed —
Mirtazapine 15 mg 71610-0717-15 Aphena 15 tablets — AB FDA listed —
Mirtazapine 15 mg 71610-0853-15 Aphena 15 tablets — AB FDA listed —
Mirtazapine 15 mg 72162-1639-00 Bryant 1000 tablets — AB FDA listed —
Mirtazapine 15 mg 80425-0305-01 Advanced 30 tablets — AB FDA listed —
Mirtazapine 15 mg 87441-0058-01 Unit 30 tablets — AB FDA listed —
Mirtazapine 15 mg 55154-0280-00 Cardinal 1 tablet — AB FDA listed —
mirtazapine 15 mg 72865-0369-05 XLCare 500 tablets — AB FDA listed —
Mirtazapine 15 mg 67046-0319-03 Coupler 30 tablets — AB FDA listed —
Mirtazapine 15 mg 68071-2784-09 NuCare 90 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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.

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.

🧪 Avoiding an ingredient? See Mirtazapine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerDirect_Rx
Application holderAPOTEX INC
FDA applicationANDA077666 (ANDA)
Labeler code61919
First marketedMay 2022
Product typeHuman Prescription Drug
Portfolio355 products on file

More NDCs from Direct_Rx labeler code 61919

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].

⏱️ Dosage and Administration ~2 min read ▾

2.1Recommended Dosage The recommended starting dose of mirtazapine tablets is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response to the initial 15 mg dose, increase the dose up to a maximum of 45 mg per day. Dose changes should not be made in intervals of less than 1 to 2 weeks to allow sufficient time for evaluation of response to a given dose [see Clinical Pharmacology (12.3)].

2.3Screen for Bipolar Disorder Prior to Starting Mirtazapine Tablets Prior to initiating treatment with mirtazapine tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.9)].

2.4Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of mirtazapine tablets. In addition, at least 14 days must elapse after stopping mirtazapine tablets before starting an MAOI antidepressant [see Contraindications (4) and Warnings and Precautions (5.3)].

2.5Dosage Modifications Due to Drug Interactions Strong CYP3A Inducers An increase in dosage of mirtazapine tablets may be needed with concomitant strong CYP3A inducer (e.g., carbamazepine, phenytoin, rifampin) use. Conversely, a decrease in dosage of mirtazapine tablets may be needed if the CYP3A inducer is discontinued [see Drug Interactions (7)]. Strong CYP3A Inhibitors A decrease in dosage of mirtazapine tablets may be needed with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin).

Conversely, an increase in dosage of mirtazapine tablets may be needed if the CYP3A4 inhibitor is discontinued [see Drug Interactions (7)]. Cimetidine A decrease in dosage of mirtazapine tablets may be needed with concomitant use of cimetidine. Conversely, an increase in dosage of mirtazapine tablets may be needed if cimetidine is discontinued [see Drug Interactions (7)].

2.6Discontinuation of Mirtazapine Tablets Treatment Adverse reactions may occur upon discontinuation or dose reduction of mirtazapine tablets [see Warnings and Precautions (5.14)]. Gradually reduce the dosage of mirtazapine tablets rather than stopping abruptly whenever possible.

💊 Dosage Forms and Strengths 89 words ▾

Mirtazapine Tablets, USP 15 mg are available for oral administration as pale yellow, oval-shaped, scored, film-coated tablets imprinted "APO" on one side and "MI" bisect "15" on the other side. Mirtazapine Tablets, USP 30 mg are available for oral administration as light pink, oval-shaped, scored, film-coated tablets imprinted "APO" on one side and "MI" bisect "30" on the other side. Mirtazapine Tablets, USP 45 mg are available for oral administration as white to off-white, oval-shaped, unscored, film-coated tablets imprinted "APO" on one side and "MI-45" on the other side.

⛔ Contraindications 93 words ▾

Mirtazapine tablets are contraindicated in patients: • Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.3), Drug Interactions (7)]. • With a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine tablets. Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS),Stevens-Johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of mirtazapine tablets [see WARNINGS AND PRECAUTIONS (5.6), ADVERSE REACTIONS (6.2)].

⚠️ Warnings and Cautions ~3 min read ▾

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18 to 24 5 additional patients Decreases Compared to Placebo 25 to 64 1 fewer patients ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication of clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.

Consider changing the therapeutic regimen, including possibly discontinuing mirtazapine tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Agranulocytosis In premarketing clinical trials, 2 (1 with Sjögren’s Syndrome) out of 2796 patients treated with mirtazapine tablets developed agranulocytosis [absolute neutrophil count (ANC) <500/mm3 with associated signs and symptoms, e.g., fever, infection, etc.] and a third patient developed severe neutropenia (ANC <500/mm3 without any associated symptoms). For these 3 patients, onset of severe neutropenia was detected on days 61, 9, and 14 of treatment, respectively. All 3 patients recovered after mirtazapine tablets were stopped.

If a patient develops a sore throat, fever, stomatitis, or other signs of infection, along with a low white blood cell (WBC) count, treatment with mirtazapine tablets should be discontinued and the patient should be closely monitored.

5.3Serotonin Syndrome Serotonergic antidepressants, including mirtazapine tablets, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4), Drug Interactions (7)].

Serotonin syndrome can also occur when these drugs are used alone. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., na… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

The following adverse reactions are described in more detail in other sections of the prescribing information: • Hypersensitivity [see Contraindications (4)] • Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1)] • Agranulocytosis [see Warnings and Precautions (5.2)] • Serotonin Syndrome [see Contraindications (4), Warnings and Precautions (5.3), Drug Interactions (7)] • Angle-Closure Glaucoma [see Warnings and Precautions (5.4)] • QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.5)] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6)] • Increased Appetite and Weight Gain [see Warnings and Precautions (5.7)] • Somnolence [see Warnings and Precautions (5.8)] • Activation of Mania or Hypomania [see Warnings and Precautions (5.9)] • Seizures [see Warnings and Precautions (5.10)] • Elevated Cholesterol and Triglycerides [see Warnings and Precautions (5.11)] • Hyponatremia [see Warnings and Precautions (5.12)] • Transaminase Elevations [see Warnings and Precautions (5.13)] • Discontinuation Syndrome [see Warnings and Precautions (5.14)] • Use in Patients with Concomitant Illness [see Warnings and Precautions (5.15)]

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below are from clinical trials in which mirtazapine tablets were administered to 2796 patients in phase 2 and 3 clinical studies. The trials consisted of double-blind controlled and open-label studies, inpatient and outpatient studies, fixed dose, and titration studies.

Adverse Reactions Leading to Discontinuation of Treatment Approximately 16% of the 453 patients who received mirtazapine tablets in U.S. 6-week placebo-controlled clinical trials discontinued treatment due to an adverse reaction, compared to 7% of the 361 placebo-treated patients in those studies. The most common reactions leading to discontinuation (≥1% and at a rate at least twice that of placebo) are included in Table 2: Table 2: Adverse Reactions (≥1% and at least twice placebo) Leading to Discontinuation of Mirtazapine Tablets in 6-Week Clinical Trials in Patients with MDD Mirtazapine Tablets (n=453) Placebo (n=361) Somnolence 10.4% 2.2% Nausea 1.5% 0% Common Adverse Reactions The most common adverse reactions (≥5% and twice placebo) associated with the use of mirtazapine tablets are listed in Table 3.

Table 3: Adverse Reactions (≥5% and twice placebo) in 6-Week U.S. Clinical Trials of Mirtazapine Tablets in Patients with MDD Mirtazapine Tablets (n=45 3) Placebo (n=3 61) Somnolence 54% 18% Increased Appetite 17% 2% Weight Gain 12% 2% Dizziness 7% 3% Table 4 enumerates adverse reactions that occurred in ≥1% of mirtazapine tablets-treated patients and were more frequent than the placebo-treated patients, who participated in 6-week, U.S. placebo-controlled trials in which patients were dosed in a range of 5 to 60 mg/day.

This table shows the percentage of patients in each group who had at least 1 episode of an adverse reaction at some time during their treatment. Table 4: Adverse Reactions (≥1% and greater than placebo) in 6-Week U.S. Clinical Studies of Mirtazapine Tablets in Patients with MDD Mirtazapine Tablets (n=453) Placebo (n=361) Body as a Whole Asthenia 8% 5% Flu Syndrome 5% 3% Back Pain 2% 1% Digestive System Dry Mouth 25% 15% Increased Appetite 17% 2% Constipation 13% 7% Metabolic and Nutritional Disorders Weight Gain 12% 2% Peripheral Edema 2% 1% Edema 1% 0% Musculoskeletal System Myalgia 2% 1% Nervous System Somnolence 54% 18% Dizziness 7% 3% Abnormal Dreams 4% 1% Thinking Abnormal 3% 1% Tremor 2% 1% Confusion 2% 0% Respiratory System Dyspnea 1% 0% Urogenital System Urinary Frequency 2% 1% ECG Changes The electrocardiograms for 338 patients who r… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

Table 5 includes clinically important drug interactions with Mirtazapine Tablets [see Clinical Pharmacology (12.3)]. Table 5: Clinically Important Drug Interactions with Mirtazapine Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including Mirtazapine Tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Mirtazapine tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.4), Contraindications (4), Warnings and Precautions (5.3)] Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with mirtazapine tablets increases the risk of serotonin syndrome.

Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of mirtazapine tablets and/or concomitant serotonergicdrugs [see Warnings and Precautions (5.3)] Examples SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, amphetamines, St. John’s Wort, tramadol, tryptophan, buspirone Strong CYP3A Inducers Clinical Impact The concomitant use of strong CYP3A inducers with mirtazapine tablets decreases the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)].

Intervention Increase the dose of mirtazapine tablets if needed with concomitant CYP3A inducer use. Conversely, a decrease in dosage of Mirtazapine Tablets may be needed if the CYP3A inducer is discontinued [see Dosage and Administration(2.5)]. Examples phenytoin, carbamazepine, rifampin Strong CYP3A Inhibitors Clinical Impact The concomitant use of strong CYP3A inhibitors with mirtazapine tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)].

Intervention Decrease the dose of mirtazapine tablets if needed with concomitant strong CYP3A inhibitor use. Conversely, an increase in dosage of mirtazapine tablets may be needed if the CYP3A inhibitor is discontinued [see Dosage and Administration (2.5)]. Examples itraconazole, ritonavir, nefazodone CimetidineCimetidine Clinical Impact The concomitant use of cimetidine, a CYP1A2, CYP2D6, and CYP3A inhibitor, with mirtazapine tablets may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3)] Intervention Decrease the dose of mirtazapine tablets if needed with concomitant cimetidine use.

Conversely, an increase in dosage of mirtazapine tablets may be needed if cimetidine is discontinued [see Dosage and Administration (2.5)]. Benzodiazepines and Alcohol Clinical Impact The concomitant use of benzodiazepines or alcohol with mirtazapine tablets increases the impairment of cognitive and motor skills produced by mirtazapine tablets alone. Intervention Avoid concomitant use of benzodiazepines and alcohol with mirtazapine tablets [see Warnings and Precautions (5.8), Clinical Pharmacology (12.3)].

Examples diazepam, alprazolam, alcohol Drugs that Prolong QTc Interval Clinical Impact The concomitant use of other drugs which prolong the QTc interval with mirtazapine tablets, increase the risk of QTc prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes). Intervention Use caution when using mirtazapine tablets concomitantly with drugs that prolong the QTc interval [see Warnings and Precautions (5.5), Clinical Pharmacology (12.3)]. Warfarin Clinical Impact The concomitant use of warfarin with mirtazapine tablets may result in an increase in INR [see Clinical Pharmacology (12.3)].

Intervention Monitor INR during concomitant use of warfarin with mirtazapine tablets

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at HTTPS://WOMENSMENTALHEALTH.ORG/CLINICAL-AND-RESEARCH-PROGRAMS/PREGNANCYREGISTRY/ANTIDEPRESSANTS/. Risk Summary Prolonged experience with mirtazapine in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

There are risks associated with untreated depression in pregnancy (see CLINICAL CONSIDERATIONS). In animal reproduction studies, oral administration of mirtazapine to pregnant rats and rabbits during the period of organogenesis revealed no evidence of teratogenic effects up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg, respectively, based on mg/m2 body surface area. However, in rats, there was an increase in post implantation loss at 20 times the MRHD based on mg/m2 body surface area.

Oral administration of mirtazapine to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths and a decrease in pup birth weights at doses 20 times the MRHD based on mg/m2 body surface area (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.

Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Data Animal Data Mirtazapine was administered orally to pregnant rats and rabbits during the period of organogenesis at doses of 2.5, 15, and 100 mg/kg/day and 2.5, 10, and 40 mg/kg/day, respectively, which are up to 20 and 17 times the maximum recommended human dose (MRHD) of 45 mg based on mg/m2 body surface area, respectively. No evidence of teratogenic effects was observed.

However, in rats, there was an increase in post implantation loss in dams treated with mirtazapine at 100 mg/kg/day which is 20 times the MRHD based on mg/m2 body surface area. Oral administration of mirtazapine at doses of 2.5, 15, and 100 mg/kg/day to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths during the first 3 days of lactation and a decrease in pup birth weights at 20 times the MRHD based on mg/m2 body surface area. The cause of these deaths is not known.

The no effect dose level is 3 times the MRHD based on mg/m2 body surface area.

8.2Lactation Risk Summary Data from published literature report the presence of mirtazapine in human milk at low levels with relative infant doses for mirtazapine ranging between 0.6 and 2.8% of the maternal weight-adjusted dose (see Data). No adverse effects on the breastfed infant have been reported in most cases of maternal use of mirtazapine. There are no data on the effects of mirtazapine on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mirtazapine and any potential adverse effects on the breastfed infant from mirtazapine or from the u… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 99 words ▾

Human Experience In premarketing clinical studies, there were reports of mirtazapine tablets overdose alone or in combination with other pharmacological agents. Signs and symptoms reported in association with overdose included disorientation, drowsiness, impaired memory, and tachycardia. Based on postmarketing reports, serious outcomes (including fatalities) may occur at dosages higher than the recommended doses, especially with mixed overdoses.

In these cases, QT prolongation and Torsades de Pointes have also been reported [see Warnings and Precautions (5.5), Adverse Reactions (6.2), and Drug Interactions (7)]. Overdose Management No specific antidotes for mirtazapine are known. Contact Poison Control (1-800-222-1222) for the latest recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α2-adrenergic inhibitory auto-receptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.

12.2Pharmacodynamics In preclinical studies, mirtazapine acts as an antagonist at α2-adrenergic inhibitory auto-receptors and heteroreceptors and as an antagonist at serotonin 5-HT2 and 5-HT3 receptors. Mirtazapine has no significant affinity for the 5-HT1A and 5-HT1B receptors. Mirtazapine also acts as an antagonist of histamine (H1) receptors, peripheral α1-adrenergic receptors, and muscarinic receptors.

Actions at these receptors may explain some of the other clinical effects of mirtazapine (e.g., its prominent somnolent effects and orthostatic hypotension may be explained by its inhibition of histamine (H1) receptors and peripheral α1-adrenergic receptors, respectively). Cardiac Electrophysiology The effect of mirtazapine tablets on QTc interval was assessed in healthy subjects. At a dose of 75 mg (1.67 times the maximum recommended dosage), mirtazapine tablets do not prolong the QTc interval to a clinically meaningful extent.

12.3Pharmacokinetics Plasma levels of mirtazapine are linearly related to dose over a dose range of 15 to 80 mg (1.78 times the maximum recommended dose). Steady state plasma levels of mirtazapine are attained within 5 days, with about 50% accumulation (accumulation ratio=1.5). The (–) enantiomer has an elimination half-life that is approximately twice as long as the (+) enantiomer and therefore achieves plasma levels that are about 3 times as high as that of the (+) enantiomer.

Absorption Mirtazapine has an absolute bioavailability of about 50% following oral administration. Peak plasma concentrations of mirtazapine are reached within about 2 hours post dose. Food Effect The presence of food in the stomach has a minimal effect on both the rate and extent of absorption.

Distribution Mirtazapine is approximately 85% bound to plasma proteins over a concentration range of 0.01 to 10 mcg/mL. Elimination Mirtazapine has a half-life of about 20 to 40 hours following oral administration of mirtazapine tablets Metabolism Mirtazapine is extensively metabolized after oral administration. Major pathways of bio-transformation are demethylation and hydroxylation followed by glucuronide conjugation.

In vitro data from human liver microsomes indicate that CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A is considered to be responsible for the formation of the N-desmethyl and N-oxide metabolite. Several unconjugated metabolites possess pharmacological activity but are present in the plasma at very low levels. Excretion Mirtazapine and its metabolites are eliminated predominantly (75%) via urine with 15% in feces.

Specific Populations Geriatric Patients Following oral administration of mirtazapine tablets 20 mg/day for 7 days to subjects of varying ages (range 25 to 74 years old), oral clearance of mirtazapine was reduced in the elderly compared to the younger subjects. The clearance in elderly males was 40% lower compared to younger males, while the clearance was 10% lower in elderly females compared to younger females [see Warnings and Precautions (5.15), Use in Specific Populations (8.5)]. Male and Female Patients The mean elimination half-life of mirtazapine after oral administration ranges from approximately 20 to 40 hours across age and gender subgroups, with females of all ages exhibiting significantly longer elimination half-lives than males (mean half-life of 37 hours for females vs.

26 hours for males). Race There have been no clinical studies to evaluate the effect of race on the pharmacokinetics of mirtazapine tablets. Patients with Renal Impairment When compared to subjects with normal renal function, tot… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 167 words ▾

Mirtazapine tablets are supplied as: Mirtazapine Tablets, USP 15 mg are available for oral administration as pale yellow, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “15” on the other side. They are supplied as follows: Bottles of 30 NDC 60505-0247-1 Bottles of 1,000 NDC 60505-0247-8 Mirtazapine Tablets, USP 30 mg are available for oral administration as light pink, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “30” on the other side. They are supplied as follows: Bottles of 30 NDC 60505-0248-1 Bottles of 1,000 NDC 60505-0248-8 Mirtazapine Tablets, USP 45 mg are available for oral administration as white to off-white, oval-shaped, unscored, film-coated tablets imprinted “APO” on one side and “MI-45” on the other side.

They are supplied as follows: Bottles of 30 NDC 60505-0249-1 Bottles of 1,000 NDC 60505-0249-8 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

📋 Description 131 words ▾

Mirtazapine tablets contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2­-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the empirical formula of C17H19N3.

Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture: [structure] Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine.

Each tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. In addition, mirtazapine tablets, USP 15 mg and 30 mg contains iron oxide yellow and mirtazapine tablets, USP 30 mg contains iron oxide red.

💬 Medication Guide ~3 min read ▾

Mirtazapine Tablets, USP (mir taz’ a peen) Medication Guide available at www1.apotex.com/products/us What is the most important information I should know about mirtazapine tablets? Mirtazapine tablets may cause serious side effects, including: • Increased risk of suicidal thoughts or actions in some children and young adults. Mirtazapine tablets, and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. mirtazapine tablets are not for use in children. o Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions? o 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. o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o 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: • attempts to commit suicide • acting aggressive, being angry or violent • new or worse depression • panic attacks • new or worse irritability • an extreme increase in activity or talking (mania) • acting on dangerous impulses • thoughts about suicide or dying • new or worse anxiety • feeling very agitated or restless • trouble sleeping • other unusual changes in behavior or mood What are mirtazapine tablets?

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

Do not take mirtazapine 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 • if you are allergic to mirtazapine or any of the ingredients in mirtazapine tablets. See the end of this Medication Guide for a complete list of ingredients in mirtazapine tablets Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after you stop treatment with mirtazapine tablets. Before taking mirtazapine tablets, tell your healthcare provider about all your medical conditions, including if you: • have a history of suicide or depression • have a history or family history of bipolar disorder, mania or hypomania • have a low white blood cell count • have glaucoma (high pressure in the eye) • have or had heart problems or stroke • have an abnormal heart beat called QT prolongation or a family history of QT prolongation • have seizures • have high cholesterol or triglyceride levels • have low sodium levels in your blood • have or had kidney or liver problems • have low blood pressure • are pregnant or plan to become pregnant.

It is not known if mirtazapine tablets will harm your unborn baby. • Talk to your healthcare provider if you become pregnant or think you may be pregnant during treatment with mirtazapine tablets. • If you become pregnant while taking mirtazapine tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or visiting online at HTTP://WOMENSMENTALHEALTH.ORG/CLINICAL-AND-RESEARCH-PROGRAMS/PREGNANCYRE… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~1 min read ▾

The efficacy of mirtazapine tablets as a treatment for major depressive disorder was established in 4 placebo- controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depressive disorder. Patients were titrated with mirtazapine tablets from a dose range of 5 mg to 35 mg/day. The mean mirtazapine dose for patients who completed these 4 studies ranged from 21 to 32 mg/day.

Overall, these studies demonstrated mirtazapine tablets to be superior to placebo on at least 3 of the following 4 measures: 21-Item Hamilton Depression Rating Scale (HDRS) total score; HDRS Depressed Mood Item; CGI Severity score; and Montgomery and Asberg Depression Rating Scale (MADRS). Superiority of mirtazapine tablets over placebo was also found for certain factors of the HDRS, including anxiety/somatization factor and sleep disturbance factor. Examination of age and gender subsets of the population did not reveal any differential responsiveness on the basis of these subgroupings.

In a longer-term study, patients meeting (DSM-IV) criteria for major depressive disorder who had responded during an initial 8 to 12 weeks of acute treatment on mirtazapine tablets were randomized to continuation of mirtazapine tablets or placebo for up to 40 weeks of observation for relapse. Response during the open phase was defined as having achieved a HAM-D 17 total score of ≤8 and a CGI-Improvement score of 1 or 2 at 2 consecutive visits beginning with week 6 of the 8 to 12 weeks in the open-label phase of the study.

Relapse during the double-blind phase was determined by the individual investigators. Patients receiving continued mirtazapine tablets treatment experienced significantly lower relapse rates over the subsequent 40 weeks compared to those receiving placebo. This pattern was demonstrated in both male and female patients.

🧪 Nonclinical Toxicology ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies were conducted with mirtazapine given in the diet at doses of 2, 20, and 200 mg/kg/day to mice and 2, 20, and 60 mg/kg/day to rats. The highest doses used are approximately 20 and 12 times the maximum recommended human dose (MRHD) of 45 mg/day, based on body surface area (mg/m2) in mice and rats, respectively. There was an increased incidence of hepatocellular adenoma and carcinoma in male mice at the high dose.

In rats, there was an increase in hepatocellular adenoma in females at the mid and high doses and in hepatocellular tumors and thyroid follicular adenoma/cystadenoma and carcinoma in males at the high dose. Mutagenesis Mirtazapine was not mutagenic or clastogenic and did not induce general DNA damage as determined in several genotoxicity tests: Ames test, in vitro gene mutation assay in Chinese hamster V 79 cells, in vitro sister chromatid exchange assay in cultured rabbit lymphocytes, in vivo bone marrow micronucleus test in rats, and unscheduled DNA synthesis assay in HeLa cells.

Impairment of Fertility In a fertility study in rats, mirtazapine was given at doses up to 100 mg/kg [20 times the maximum recommended human dose (MRHD), based on body surface area (mg/m2)]. Mating and conception were not affected by the drug, but estrous cycling was disrupted at doses that were 3 or more times the MRHD, and pre-implantation losses occurred at 20 times the MRHD.

📄 Package Label / Principal Display Panel 1 words ▾

153-60

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Medicare Part D (outpatient prescription) spending for Mirtazapine — the program that covers self-administered drugs. 11 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 Mirtazapine. 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
$39.56M
Claims incl. refills
2.2M
Beneficiaries
1.1M
Spend / beneficiary
$35.27
Spend / claim
$18.20
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.

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← 61919-0130-60 · DIRECT 61919-0158-22 · DIRECT →
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