Home › NDC Lookup › Ingredients › Mirtazapine › 80425-0305-03
Mirtazapine 15 mg Tablet, Film Coated, 90-count — NDC 80425-0305-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mirtazapine 15 mg Tablet, Film Coated, 90-count — NDC 80425-0305-3 (Billing 80425-0305-03)

by Advanced Rx Pharmacy of Tennessee, LLC · 90 TABLET, FILM COATED in 1 BOTTLE

This is a package of 90 tablets of Mirtazapine 15 mg Tablet, Film Coated from Advanced Rx Pharmacy of Tennessee, LLC, marketed since Apr 2023 and currently FDA-listed.

NDC 80425-0305-03
🏷️ FDA NDC (as labeled) 80425-0305-3 billing pads the package segment with a zero
This package
Contains90-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.6699/unit — full pricing hub ↓
Product page 80425-0305-01 Also comes in: 30 tablets 80425-0305-1 60 tablets 80425-0305-2
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80425-0305-3
Product NDC 80425-0305
11-digit billing NDC 80425030503
NCPDP billing unit EA — each (per item)
RxCUI 311725
UNII A051Q2099Q
Application # ANDA076921
SPL Set ID f8c383c1-d1b3-ceaa-e053-6294a90a6053
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-07
Route ORAL
Dosage form TABLET, FILM COATED
Substance MIRTAZAPINE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 311725
Why two NDCs? The FDA registers this code as 80425-0305-3 — a 5-4-1 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 package segment → 80425-0305-03. 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

📖 What it is MedlinePlus · NLM

Mirtazapine is used to treat depression. Mirtazapine is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain to maintain mental balance.

Read the full MedlinePlus article ↗
📗 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 $60.29 / 90 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
80425-0305-01 80425-0305-1 Main listing 30 TABLET, FILM COATED in 1 BOTTLE 2023-04-07 — Active
80425-0305-02 80425-0305-2 60 TABLET, FILM COATED in 1 BOTTLE 2023-04-07 — Active
80425-0305-03 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE 2023-04-07 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet, film coated in 1 bottle.
How does this package differ from NDC 80425-0305-01?
Both are Mirtazapine 15 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 90-count one, while NDC 80425-0305-01 is the 30 tablets package.
What NDC number is used to bill for this package of Mirtazapine 15 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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 mg 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 mgthis 80425-0305-03 Advanced 90 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color yellow
ShapeCapsule
Imprint0;8;A
Size9 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.

Manufacturer & labeler

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA076921 (ANDA)
Labeler code80425
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio254 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.

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.
🚨 Boxed Warning 🎯 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
🚨 Boxed Warning 60 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)]. Mirtazapine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

🎯 Indications and Usage 22 words ▾

1. Indications and Usage 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. Dosage and Administration

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 116 words ▾

3. Dosage Forms and Strengths Mirtazapine tablets USP are supplied as: 7.5 mg tablets: White, biconvex, capsule shaped film coated tablets with “11” debossed on one side and “A” debossed on the other side. 15 mg tablets: Yellow, biconvex, capsule shaped film coated tablets with a score line in between “0” and “8” on one side and “A” debossed on the other side.

30 mg tablets: Reddish brown, biconvex, capsule shaped film coated tablets with a score line in between “0” and “9” on one side and “A” debossed on the other side. 45 mg tablets: White, biconvex, capsule shaped film coated tablets with “10” debossed on one side and “A” debossed on the other side.

⛔ Contraindications 94 words ▾

4. Contraindications 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. Warnings and Precautions

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 Patients with Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 64 years old 1 fewer patient ≥65 years old 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, 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 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 was 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 should be discontinued and the patient should be closely monitored.

5.3Serotonin Syndrome Serotonergic antidepressants, including mirtazapine, 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),… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6. Adverse Reactions 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 was 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 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 in 6-Week Clinical Trials in Patients with MDD Mirtazapine (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 are listed in Table 3. Table 3: Adverse Reactions (≥5% and twice placebo) in 6-Week U.S. Clinical Trials of Mirtazapine in Patients with MDD Mirtazapine (n=453) Placebo (n=361) 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-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 in Patients with MDD Mirtazapine (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 received mirtazapine and 261 patients who received placebo in 6-week, placebo-controlled trial… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7. Drug Interactions Table 5 includes clinically important drug interactions with mirtazapine [see CLINICAL PHARMACOLOGY (12.3)]. Table 5: Clinically Important Drug Interactions with Mirtazapine Table 5: Clinically Important Drug Interactions with Mirtazapine Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of serotonergic drugs, including mirtazapine, and MAOIs increases the risk of serotonin syndrome.

Intervention Mirtazapine is 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 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 and/or concomitant serotonergic drugs [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 decreases the plasma concentration of mirtazapine [see CLINICAL PHARMACOLOGY (12.3)].

Intervention Increase the dose of mirtazapine if needed with concomitant CYP3A inducer use. Conversely, a decrease in dosage of mirtazapine 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 may increase the plasma concentration of mirtazapine [see CLINICAL PHARMACOLOGY (12.3)].

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

Intervention Decrease the dose of mirtazapine if needed with concomitant cimetidine use. Conversely, an increase in dosage of mirtazapine 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 increases the impairment of cognitive and motor skills produced by mirtazapine alone.

Intervention Avoid concomitant use of benzodiazepines and alcohol with mirtazapine [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, increase the risk of QT prolongation and/or ventricular arrhythmias (e.g., Torsades de Pointes). Intervention Use caution when using mirtazapine 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 may result in an increase in INR [see CLINICAL PHARMACOLOGY (12.3)]. Intervention Monitor INR during concomitant use of warfarin with mirtazapine.

👥 Use in Specific Populations ~3 min read ▾

8. Use and Specific Populations

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 mirtazpine 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 postimplantation 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 postimplantation 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 f… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 100 words ▾

10. Overdosage Human Experience In premarketing clinical studies, there were reports of mirtazapine 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. Clinical Pharmacology

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 autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.

12.2Pharmacodynamics In preclinical studies, mirtazapine acts as an antagonist at α2-adrenergic inhibitory autoreceptors 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 on QTc interval was assessed in healthy subjects. At a dose of 75 mg (1.67 times the maximum recommended dosage), mirtazapine does 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. 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.

Patients with Renal Impairment When compared to subjects with normal renal function, total bo… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 81 words ▾

16. How Supplied/Storage and Handling Mirtazapine tablets, USP are supplied as: 15 mg Tablets – Yellow, biconvex, capsule-shaped film-coated tablets with a score line in between “0” and “8” on one side and “A” debossed on the other side. Bottles of 30 Tablets NDC: 80425-0305-01 Bottles of 60 Tablets NDC: 80425-0305-02 Bottles of 90 Tablets NDC: 80425-0305-03 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from light and moisture.

📋 Description 147 words ▾

11. Description Mirtazapine tablets, USP contain mirtazapine USP. 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 molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture: Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water.

Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow.

Description

💬 Medication Guide ~3 min read ▾

Medication Guide MEDICATION GUIDE Mirtazapine Tablets, USP for oral use (mir taz’ a peen) 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. 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?

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: attempts to commit suicide acting on dangerous impulses acting aggressive, being angry or violent thoughts about suicide or dying new or worse depression new or worse anxiety panic attacks feeling very agitated or restless new or worse irritability trouble sleeping an extreme increase in activity or talking (mania) 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 https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/. The purpose of this registry is to monitor the pregnan… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~1 min read ▾

14. Clinical Studies The efficacy of mirtazapine 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 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 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 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 were randomized to continuation of mirtazapine 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 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. Non-Clinical Toxicology

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 6 words ▾

label 1 label 2 label 3

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Advanced Rx Pharmacy of Tennessee, LLC. 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 30 tablets (80425-0305-01), 60 tablets (80425-0305-02). 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?
Advanced Rx Pharmacy of Tennessee, LLC 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.
← 80425-0304-01 · Advanced 80425-0306-01 · Advanced →
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.