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Buspirone hydrochloride 15 mg Tablet, 500-count — NDC 11788-0060-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Buspirone hydrochloride 15 mg Tablet, 500-count — NDC 11788-060-05 (Billing 11788-0060-05)

by AiPing Pharmaceutical, Inc. · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of Buspirone hydrochloride 15 mg Tablet from AiPing Pharmaceutical, Inc., marketed since Sep 2025 and currently FDA-listed; retail pharmacies pay about $0.0430 per tablet (NADAC).

NDC 11788-0060-05
🏷️ FDA NDC (as labeled) 11788-060-05 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0430 NADAC Per package$21.50 / 500 tablets Pack sizes4 compare ↓
Also priced by: Part D plans $0.0755/unit — full pricing hub ↓
Product page 11788-0060-01 Also comes in: 60 tablets 11788-060-60 100 tablets 11788-060-01 180 tablets 11788-060-03
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 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

⚠️
Other active recalls for Buspirone Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Apr 13, 2026 — Subpotent drug (Unichem Pharmaceuticals USA Inc.) · FDA recall D-0511-2026
Class II · Mar 16, 2023 — CGMP Deviations (Northwind Pharmaceuticals LLC) · FDA recall D-0549-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11788-060-05
Product NDC 11788-060
11-digit billing NDC 11788006005
NCPDP billing unit EA — each (per item)
RxCUI 866018, 866083, 866090, 866094, 866111
UNII 207LT9J9OC
Application # ANDA202087
SPL Set ID 55810b17-4796-49d0-90e4-8e075d62eda4
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-26
Route ORAL
Dosage form TABLET
Substance BUSPIRONE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 027378
GCN 28892
HICL code 001620
Ingredient (HICL) Buspirone Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2F
Therapeutic class — specific (HIC3) Anti-Anxiety Drugs
AHFS code 28:24.12.00
AHFS class Non-Benzodiazepine Anxiolytics
FDB label name BUSPIRONE HCL 15 MG TABLET
FDB brand name Buspirone Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 027378
  • GCN: 28892
  • HICL (First Databank): 001620
  • AHFS class code: 28:24.12.00
  • RxCUI (RxNorm): 866018
Why two NDCs? The FDA registers this code as 11788-060-05 — 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 → 11788-0060-05. 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 Azaspirodecanedione derivatives class.

Drug family (ATC) Azaspirodecanedione derivatives
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 BUSPIRONE HCL 15 MG TABLET Ingredient Buspirone Hcl
📖 What it is MedlinePlus · NLM

Buspirone is used to treat anxiety. Buspirone is in a class of medications called anxiolytics. It works by changing the amounts of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Buspirone isn't a quick-fix medication — it generally takes a few weeks of consistent daily use before you notice a real improvement in your anxiety. This is different from benzodi...
  • How long does buspirone take to start working?
  • Either can work, but the key is to pick one and be consistent every single day. Food significantly increases how much buspirone your body absorbs — so if you start taking it with f...
  • Should I take buspirone with food or on an empty stomach?
📖 Read our full Buspirone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eaPer package
Retail pharmacies payNADAC · weekly $0.043 $21.50 / 500 tablets
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 $0.0755 $37.75 / 500 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jun 2026 Jul 2026 Aug 2026 Sep 2026 $0.043 $0.042
▲ Up 2% over the last 4 months.
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 Per unit Per pack Marketing startMarketing endStatus
11788-0060-01 11788-060-01 Main listing 100 TABLET in 1 BOTTLE $0.0430 / ea $4.30 2025-09-26 — Active
11788-0060-05 You're viewing this 500 TABLET in 1 BOTTLE $0.0430 / ea $21.48 2025-09-26 — Active
11788-0060-03 11788-060-03 180 TABLET in 1 BOTTLE — — 2026-08-01 — Active
11788-0060-60 11788-060-60 60 TABLET in 1 BOTTLE — — 2026-08-01 — Active

You're viewing the largest of 4 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0430 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 11788-0060-60?
Both are Buspirone hydrochloride 15 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 11788-0060-60 is the 60 tablets package.
What NDC number is used to bill for this package of Buspirone hydrochloride 15 mg Tablet?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Buspirone Hydrochloride 15 mg 42806-0085-01 Epic 100 tablets $0.042 AB Availability likely save 2%
Buspirone hydrochloride 15 mg 42806-0664-01 EPIC 100 tablets $0.042 AB Availability likely save 2%
Buspirone Hydrochloride 15 mg 00093-1003-01 Teva 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 00378-1165-05 Mylan 500 tablets $0.043 AB Availability likely —
Buspirone hydrochloride 15 mg 00904-6899-61 Major 100 tablets $0.043 AB Availability likely —
Buspirone hydrochloride 15 mgthis 11788-0060-05 AiPing 500 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 16729-0203-01 Accord 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 23155-0025-01 Heritage 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 24689-0921-01 APNAR 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 29300-0246-01 Unichem 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 29300-0477-01 Unichem 100 tablets $0.043 AB Availability likely —
Buspirone hydrochloride 15 mg 50268-0135-15 AvPAK 50 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 51079-0960-20 Mylan 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 59651-0392-01 Aurobindo 100 tablets $0.043 AB Availability likely —
Buspirone hydrochloride 15 mg 60687-0823-01 American 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 64380-0743-03 Strides 60 tablets $0.043 AB Availability likely —
Buspirone hydrochloride 15 mg 68382-0182-01 Zydus 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 69584-0093-10 Oxford 100 tablets $0.043 AB Availability likely —
busPIRone HCl 15 mg 72888-0065-01 Advagen 100 tablets $0.043 AB Availability likely —
Buspirone Hydrochloride 15 mg 75834-0269-01 Nivagen 100 tablets $0.050 AB Discontinued +17%
Buspirone Hydrochloride 15 mg 00615-7689-05 NCS 15 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 42543-0743-03 Strides 60 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 48433-0013-20 Safecor 1 tablet — AB FDA listed —
Buspirone Hydrochloride 15 mg 50090-5886-01 A-S 60 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 50090-6188-00 A-S 180 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 50090-6971-01 A-S 60 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 50090-7161-01 A-S 60 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 50090-7293-00 A-S 180 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 51407-0416-05 Golden 500 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 51655-0015-26 Northwind 90 tablets — AB FDA listed —
Buspirone hydrochloride 15 mg 55154-3364-00 Cardinal 10 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 63187-0402-30 Proficient 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 63629-2412-01 Bryant 500 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 63629-2413-01 Bryant 100 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 64980-0653-01 Rising 100 tablets — AB FDA listed —
buspirone hydrochloride 15 mg 65841-0783-01 Zydus 100 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 68071-2987-03 NuCare 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 68071-3834-03 NuCare 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 68788-7968-01 Preferred 180 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 68788-8681-01 Preferred 100 tablets — AB FDA listed —
Buspirone hydrochloride 15 mg 70518-0380-00 REMEDYREPACK 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 70518-2660-00 REMEDYREPACK 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 70518-2987-00 REMEDYREPACK 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 70518-4052-00 REMEDYREPACK 30 tablets — AB FDA listed —
BusPIRone Hydrochloride 15 mg 71205-0280-30 Proficient 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 71335-1605-01 Bryant 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 71335-1752-01 Bryant 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 71335-2060-01 Bryant 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 71335-2073-01 Bryant 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 71335-2576-01 Bryant 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 71610-0183-60 Aphena 90 tablets — AB FDA listed —
Buspirone hydrochloride 15 mg 71610-0206-30 Aphena 30 tablets — AB FDA listed —
BusPIRone Hydrochloride 15 mg 71610-0291-60 Aphena 90 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 71610-0640-30 Aphena 30 tablets — AB FDA listed —
Buspirone hydrochloride 15 mg 71610-0975-60 Aphena 90 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 72162-1926-01 Bryant 100 tablets — AB FDA listed —
Buspirone Hcl 15 mg 72189-0235-30 Direct 30 tablets — AB FDA listed —
Buspirone HCL 15 mg 72189-0620-30 Direct_Rx 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 72789-0141-01 PD-Rx 100 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 72789-0332-60 PD-Rx 60 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 76420-0724-01 Asclemed 100 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 76420-0809-01 Asclemed 100 tablets — AB FDA listed —
Buspirone hydrochloride 15 mg 77771-0237-05 Radha 500 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 80425-0303-01 Advanced 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 80425-0387-01 Advanced 30 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 82804-0963-00 Proficient 100 tablets — AB FDA listed —
Buspirone Hydrochloride 15 mg 83209-0303-15 Boswell 15 tablets — AB FDA listed —
Buspirone hydrochloride 15 mg 87441-0019-01 Unit 30 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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year 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 white
ShapeRectangle
Imprint3;53
Size17 mm
ScoringScore: 3
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerAiPing Pharmaceutical, Inc.
Application holderAIPING PHARMACEUTICAL INC
FDA applicationANDA202087 (ANDA)
Labeler code11788
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio43 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information ⚠️ Precautions 🔒 Drug Abuse and Dependence 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD).

Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.

Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.

The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials.

There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day.

In clinical trials allowing dose titration, divided doses of 20 mg to 30 mg per day were commonly employed. The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY ). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.

When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS: Drug Interactions section should be followed. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with buspirone hydrochloride tablets. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets before starting an MAOI antidepressant (see CONTRAINDICATIONS and DRUG INTERACTIONS ).

Use of Buspirone Hydrochloride Tablets with (Reversible) MAOIs, Such as Linezolid or Methylene Blue Do not start buspirone hydrochloride tablets in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered (see C ONTRAINDICATIONS and DRUG INTERACTIONS ). In some cases, a patient already receiving therapy with buspirone hydrochloride tablets may require urgent treatment with linezolid or intravenous methylene blue.

If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, buspirone hydrochloride tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first.

Therapy with buspirone hydrochloride tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS ). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg per kg with buspirone hydrochloride tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see C ONTRAINDICATIONS, WARNINGS and DRUG INTERACTIONS ).

⛔ Contraindications 105 words ▾

CONTRAINDICATIONS Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride. The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.

Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS, DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS ).

⚠️ Warnings 58 words ▾

WARNINGS The administration of buspirone hydrochloride tablets to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride has been added to a regimen including an MAOI. Therefore, it is recommended that buspirone hydrochloride tablets not be used concomitantly with an MAOI.

🤒 Adverse Reactions 39 words ▾

ADVERSE REACTIONS (See also PRECAUTIONS ) Commonly Observed The more commonly observed untoward events associated with the use of buspirone hydrochloride tablets not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement.

🆘 Overdosage 175 words ▾

OVERDOSAGE Signs and Symptoms In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as the usual outcome.

No deaths have been reported following overdosage with buspirone hydrochloride tablets alone. Rare cases of intentional overdosage with a fatal outcome were invariably associated with ingestion of multiple drugs and/or alcohol, and a causal relationship to buspirone could not be determined. Toxicology studies of buspirone yielded the following LD 50 values: mice, 655 mg/kg; rats, 196 mg/kg; dogs, 586 mg/kg; and monkeys, 356 mg/kg.

These dosages are 160 to 550 times the recommended human daily dose. Recommended Overdose Treatment General symptomatic and supportive measures should be used along with immediate gastric lavage. Respiration, pulse, and blood pressure should be monitored as in all cases of drug overdosage.

No specific antidote is known to buspirone, and dialyzability of buspirone has not been determined.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY The mechanism of action of buspirone is unknown. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the prominent sedative effect that is associated with more typical anxiolytics.

In vitro preclinical studies have shown that buspirone has a high affinity for serotonin (5-HT 1A ) receptors. Buspirone has no significant affinity for benzodiazepine receptors and does not affect GABA binding in vitro or in vivo when tested in preclinical models. Buspirone has moderate affinity for brain D 2 -dopamine receptors.

Some studies do suggest that buspirone may have indirect effects on other neurotransmitter systems. Buspirone hydrochloride is rapidly absorbed in man and undergoes extensive first-pass metabolism. In a radiolabeled study, unchanged buspirone in the plasma accounted for only about 1% of the radioactivity in the plasma.

Following oral administration, plasma concentrations of unchanged buspirone are very low and variable between subjects. Peak plasma levels of 1 ng/mL to 6 ng/mL have been observed 40 to 90 minutes after single oral doses of 20 mg. The single-dose bioavailability of unchanged buspirone when taken as a tablet is on the average about 90% of an equivalent dose of solution, but there is large variability.

The effects of food upon the bioavailability of buspirone hydrochloride tablets have been studied in eight subjects. They were given a 20 mg dose with and without food; the area under the plasma concentration-time curve (AUC) and peak plasma concentration (C max ) of unchanged buspirone increased by 84% and 116%, respectively, but the total amount of buspirone immunoreactive material did not change. This suggests that food may decrease the extent of presystemic clearance of buspirone (see DOSAGE AND ADMINISTRATION ).

A multiple-dose study conducted in 15 subjects suggests that buspirone has nonlinear pharmacokinetics. Thus, dose increases and repeated dosing may lead to somewhat higher blood levels of unchanged buspirone than would be predicted from results of single-dose studies. An in vitro protein binding study indicated that approximately 86% of buspirone is bound to plasma proteins.

It was also observed that aspirin increased the plasma levels of free buspirone by 23%, while flurazepam decreased the plasma levels of free buspirone by 20%. However, it is not known whether these drugs cause similar effects on plasma levels of free buspirone in vivo , or whether such changes, if they do occur, cause clinically significant differences in treatment outcome. An in vitro study indicated that buspirone did not displace highly protein-bound drugs such as phenytoin, warfarin, and propranolol from plasma protein, and that buspirone may displace digoxin.

Buspirone is metabolized primarily by oxidation, which in vitro has been shown to be mediated by cytochrome P450 3A4 (CYP3A4) (see PRECAUTIONS: Drug Interaction s ). Several hydroxylated derivatives and a pharmacologically active metabolite, 1-pyrimidinylpiperazine (1-PP), are produced. In animal models predictive of anxiolytic potential, 1-PP has about one quarter of the activity of buspirone, but is present in up to 20-fold greater amounts.

However, this is probably not important in humans: blood samples from humans chronically exposed to buspirone hydrochloride tablets do not exhibit high levels of 1-PP; mean values are approximately 3 ng/mL and the highest human blood level recorded among 108 chronically dosed patients was 17 ng/mL, less than 1/200th of 1-PP levels found in animals given large doses of buspirone without signs of toxicity. In a single-dose study using 14 C-labeled buspirone, 29% to 63% of the dose was excreted in the urine within 24 hours, primarily as metabolites; fecal excretion accounted for 18% to 38% of the dose.

The average elimination half-life of unchanged buspirone after single doses of 10 mg to 40 mg is about 2 to 3 hours. Special… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Buspirone Hydrochloride Tablets, USP 5 mg are available as white to slightly off-white, oval, uncoated tablets, debossed with “349” on one side and a score on the other side. NDC 11788-057-01 Bottles of 100 NDC 11788-057-05 Bottles of 500 Buspirone Hydrochloride Tablets, USP 7.5 mg are available as white to slightly off-white, oval, uncoated tablets, debossed with “350” on one side and a score on the other side. NDC 11788-058-01 Bottles of 100 Buspirone Hydrochloride Tablets, USP 10 mg are available as white to slightly off-white, oval, uncoated tablets, debossed with “351” on one side and a score on the other side.

NDC 11788-059-01 Bottles of 100 NDC 11788-059-05 Bottles of 500 Buspirone Hydrochloride Tablets, USP 15 mg are available as white to slightly off-white, rectangular, uncoated tablets, debossed with “3” and “52” with a score in between on one side and two scores on the other side. These tablets are scored to provide 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). NDC 11788-060-60 Bottles of 60 NDC 11788-060-01 Bottles of 100 NDC 11788-060-03 Bottles of 180 NDC 11788-060-05 Bottles of 500 Buspirone Hydrochloride Tablets, USP 30 mg are available as white to slightly off-white, rectangular, uncoated tablets, debossed with “3” and “53” with a score in between on one side and two scores on the other side.

These tablets are scored to provide 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet) or 10 mg (one-third of a tablet). NDC 11788-061-60 Bottles of 60 NDC 11788-061-05 Bottles of 500 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

📋 Description ~1 min read ▾

DESCRIPTION Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride.

The empirical formula C 21 H 31 N 5 O 2 •HCl is represented by the following structural formula: Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5 mg, 7.5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose.

The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected.

Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. chemical-structure

💬 Patient Medication Information ~1 min read ▾

PATIENT INSTRUCTION SHEET Buspirone Hydrochloride (bue-SPYE-rone HYE-droe-KLOR-ide) Tablets, USP Rx only HOW TO USE BUSPIRONE HYDROCHLORIDE TABLETS, 15 mg Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response. This tablet design makes dosage adjustments easy.

Each tablet is scored and can be broken accurately to provide any of the following dosages: If your doctor prescribed the 15 mg tablet: To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). HOW TO USE BUSPIRONE HYDROCHLORIDE TABLETS, 30 mg Response to buspirone varies among individuals.

Your physician may find it necessary to adjust your dosage to obtain the proper response. This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages: If your doctor prescribed the 30 mg tablet: To break a multi-scored tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below.

Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). Manufactured for: AiPing Pharmaceutical, Inc. Hauppauge, NY 11788 Revised: 07/2026 LB1563 figure 1 figure2 figure3 figure4

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Interference with Cognitive and Motor Performance Studies indicate that buspirone hydrochloride tablets are less sedating than other anxiolytics and that it does not produce significant functional impairment. However, its CNS effects in any individual patient may not be predictable. Therefore, patients should be cautioned about operating an automobile or using complex machinery until they are reasonably certain that buspirone treatment does not affect them adversely.

While formal studies of the interaction of buspirone hydrochloride with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid concomitant use of alcohol and buspirone. Potential for Withdrawal Reactions in Sedative/Hypnotic/Anxiolytic Drug-Dependent Patients Because buspirone hydrochloride tablets do not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs, it will not block the withdrawal syndrome often seen with cessation of therapy with these drugs.

Therefore, before starting therapy with buspirone hydrochloride tablets, it is advisable to withdraw patients gradually, especially patients who have been using a CNS-depressant drug chronically, from their prior treatment. Rebound or withdrawal symptoms may occur over varying time periods, depending in part on the type of drug, and its effective half-life of elimination. The syndrome of withdrawal from sedative/hypnotic/anxiolytic drugs can appear as any combination of irritability, anxiety, agitation, insomnia, tremor, abdominal cramps, muscle cramps, vomiting, sweating, flu-like symptoms without fever, and occasionally, even as seizures.

Possible Concerns Related to Buspirone's Binding to Dopamine Receptors Because buspirone can bind to central dopamine receptors, a question has been raised about its potential to cause acute and chronic changes in dopamine-mediated neurological function (e.g., dystonia, pseudo-parkinsonism, akathisia, and tardive dyskinesia). Clinical experience in controlled trials has failed to identify any significant neuroleptic-like activity; however, a syndrome of restlessness, appearing shortly after initiation of treatment, has been reported in some small fraction of buspirone-treated patients.

The syndrome may be explained in several ways. For example, buspirone may increase central noradrenergic activity; alternatively, the effect may be attributable to dopaminergic effects (i.e., represent akathisia). See ADVERSE REACTIONS: Postmarketing Experience .

🔒 Drug Abuse and Dependence 207 words ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Class Buspirone hydrochloride is not a controlled substance. Physical and Psychological Dependence In human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations.

None of the subjects were able to distinguish between buspirone hydrochloride tablets and placebo. By contrast, subjects showed a statistically significant preference for methaqualone and diazepam. Studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse.

Following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency. Although there is no direct evidence that buspirone hydrochloride tablets cause physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of buspirone hydrochloride tablets misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

📚 References 37 words ▾

REFERENCE 1. American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders-III, American Psychiatric Association, May 1980. The brands listed are trademarks of their respective owners. Manufactured for: AiPing Pharmaceutical, Inc. Hauppauge, NY 11788 Revised: 07/2026

📄 Package Label / Principal Display Panel 169 words ▾

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 5 mg-Bottle of 100s NDC 11788-057-01 5mg-label-100

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 5 mg-Bottle of 500s NDC 11788-057-05 5mg-label-500

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 7.5 mg-Bottle of 100s NDC 11788-058-01 7pt5mg-label-100

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 10 mg-Bottle of 100s NDC 11788-059-01 10mg - label - 100

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 10 mg-Bottle of 500s NDC 11788-059-05 10mg-label-500

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 15 mg-Bottle of 60s NDC 11788-060-60 15mg-label-60

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 15 mg-Bottle of 100s NDC 11788-060-01 15mg-label-100

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 15 mg-Bottle of 180s NDC 11788-060-03 15mg-label-180

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 15 mg-Bottle of 500s NDC 11788-060-05 15mg-label-500

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 30 mg-Bottle of 60s NDC 11788-061-60 30mg-label-60

PACKAGE LABEL/PRINCIPAL DISPLAY PANEL Buspirone Hydrochloride Tablets, USP 30 mg-Bottle of 500s NDC 11788-061-05 30mg-label-500

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 11788-0059-01 · AiPing 11788-0061-05 · AiPing →
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.