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Lorazepam 1 mg Tablet, 10-count — NDC 13107-0084-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lorazepam 1 mg Tablet, 10-count — NDC 13107-084-11 (Billing 13107-0084-11)

by Aurolife Pharma LLC · 10 TABLET in 1 BOTTLE

This is a package of 10 tablets of Lorazepam 1 mg Tablet from Aurolife Pharma LLC, marketed since Feb 2021 and currently FDA-listed.

NDC 13107-0084-11
🏷️ FDA NDC (as labeled) 13107-084-11 billing pads the product segment with a zero
This package
Contains10-count Pack sizes5 compare ↓
Product page 13107-0084-05 Also comes in: 10 tablets 13107-084-10 100 tablets 13107-084-01 500 tablets 13107-084-05 1000 tablets 13107-084-99
Rx only Generic On market CIV ⇄ 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

⚠️
Other active recalls for Lorazepam (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 22, 2025 — Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0551-2025
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) 13107-084-11
Product NDC 13107-084
11-digit billing NDC 13107008411
RxCUI 197900, 197901, 197902
UNII O26FZP769L
UPC 0313107083013, 0313107084010, 0313107085017
Application # ANDA203572
SPL Set ID 5b851f67-309d-4ef3-8b4b-ade8908256ea
Established class (EPC) Benzodiazepine
Chemical class Benzodiazepines
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-02-01
Route ORAL
Dosage form TABLET
Substance LORAZEPAM
TE code (Orange Book) AB · RLD · RS

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

GPI-14 57100060000310
GPI class LORazepam
Quick answers
  • GPI-14 (Medi-Span): 57100060000310
  • RxCUI (RxNorm): 197900
Why two NDCs? The FDA registers this code as 13107-084-11 — 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 → 13107-0084-11. 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 Benzodiazepine class.

Pharmacologic class Benzodiazepine
Drug family (ATC) Benzodiazepine 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

📖 What it is MedlinePlus · NLM

Lorazepam is used to relieve anxiety and treat insomnia. Lorazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow for relaxation.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. Tablets and the oral liquid are for anxiety disorders or short-term anxiety relief. The injection is used in the hospital for status epilepticus and for sed...
  • Take it exactly as your prescriber directs. If you use the liquid concentrate, mix it into water, juice, applesauce or pudding with the supplied dropper, then use it all right away...
  • No, avoid alcohol. Opioids with lorazepam can cause extreme sleepiness, slowed breathing, coma and death. Tell me about every medicine you take so we can check for problems.
  • Can I drink alcohol or take opioids with it?
📖 Read our full Lorazepam guide →
1
Nutrient depletion considerations

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

🧪 Full Lorazepam 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 tablets 100 tablets 500 tablets 1000 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 Per unit Per pack Marketing startMarketing endStatus
13107-0084-01 13107-084-01 100 TABLET in 1 BOTTLE $0.0367 / ea $3.67 2017-03-24 — Active
13107-0084-05 13107-084-05 Main listing 500 TABLET in 1 BOTTLE $0.0367 / ea $18.36 2017-03-24 — Active
13107-0084-11 You're viewing this 10 TABLET in 1 BOTTLE — — 2017-03-24 — Active
13107-0084-99 13107-084-99 1000 TABLET in 1 BOTTLE $0.0367 / ea $36.71 2017-03-24 — Active
13107-0084-10 13107-084-10 10 TABLET in 1 BOTTLE — — 2017-03-24 — Active

This pack shows little to no recent Medicaid volume — the 500 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 10-count package — 10 tablet in 1 bottle.
How does this package differ from NDC 13107-0084-10?
Both are Lorazepam 1 mg Tablet — the drug itself is identical. This page's package is the 10-count one, while NDC 13107-0084-10 is the 10 tablets package.
What NDC number is used to bill for this package of Lorazepam 1 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
Lorazepam 1 mg 00904-6008-60 Major 100 tablets $0.036 AB Discontinued —
Lorazepam 1 mg 00093-3426-01 Teva 100 tablets $0.037 AB Availability likely —
Lorazepam 1 mg 60687-0831-01 American 100 tablets $0.037 AB Availability likely —
Lorazepam 1 mg 63304-0773-01 SUN 100 tablets $0.037 AB Availability likely —
Lorazepam 1 mg 64980-0628-01 Rising 100 tablets $0.037 AB Availability likely —
Lorazepam 1 mg 69315-0905-01 Leading 100 tablets $0.037 AB Availability likely —
Ativan 1 mg 00187-0064-01 Bausch 100 tablets $44.095 AB FDA listed —
Lorazepam 1 mgthis 13107-0084-11 Aurolife 10 tablets — AB FDA listed —
Lorazepam 1 mg 50090-5508-00 A-S 30 tablets — AB FDA listed —
Lorazepam 1 mg 50090-5509-00 A-S 10 tablets — AB FDA listed —
Lorazepam 1 mg 50090-5562-00 A-S 30 tablets — AB FDA listed —
Lorazepam 1 mg 50090-5563-00 A-S 10 tablets — AB FDA listed —
Lorazepam 1 mg 51407-0997-01 Golden 100 tablets — AB FDA listed —
Lorazepam 1 mg 54348-0049-01 PharmPak, 1 tablet — AB FDA listed —
Lorazepam 1 mg 58118-1095-08 Clinical 30 tablets — AB FDA listed —
Lorazepam 1 mg 62135-0862-01 Chartwell 100 tablets — — FDA listed —
Lorazepam 1 mg 62559-0196-01 ANI 100 tablets — AB FDA listed —
Lorazepam 1 mg 67046-0230-03 Coupler 30 tablets — AB FDA listed —
Lorazepam 1 mg 67296-2238-02 Redpharm 5 tablets — AB FDA listed —
Lorazepam 1 mg 68071-3227-01 NuCare 10 tablets — AB FDA listed —
Lorazepam 1 mg 68071-3242-03 NuCare 3 tablets — AB FDA listed —
Lorazepam 1 mg 68071-4918-03 NuCare 30 tablets — AB FDA listed —
Lorazepam 1 mg 68071-5022-05 NuCare 15 tablets — AB FDA listed —
Lorazepam 1 mg 68071-5250-02 NuCare 20 tablets — AB FDA listed —
Lorazepam 1 mg 68788-7428-01 Preferred 100 tablets — AB FDA listed —
Lorazepam 1 mg 70518-0275-00 REMEDYREPACK 30 tablets — AB FDA listed —
Lorazepam 1 mg 70518-0486-00 REMEDYREPACK 30 tablets — AB FDA listed —
Lorazepam 1 mg 70518-2186-02 REMEDYREPACK 30 tablets — AB Discontinued —
Lorazepam 1 mg 70518-2442-00 REMEDYREPACK 30 tablets — AB Discontinued —
Lorazepam 1 mg 70518-3423-00 REMEDYREPACK 30 tablets — AB Discontinued —
Lorazepam 1 mg 70518-3870-00 REMEDYREPACK 30 tablets — AB Discontinued —
Lorazepam 1 mg 70518-4276-00 REMEDYREPACK 100 tablets — AB FDA listed —
Lorazepam 1 mg 71205-0235-02 Proficient 2 tablets — AB FDA listed —
Lorazepam 1 mg 71335-1467-00 Bryant 10 tablets — AB Discontinued —
Lorazepam 1 mg 71335-1694-00 Bryant 10 tablets — AB FDA listed —
Lorazepam 1 mg 71610-0122-10 Aphena 10 tablets — AB FDA listed —
Lorazepam 1 mg 71610-0229-15 Aphena 15 tablets — AB FDA listed —
Lorazepam 1 mg 71610-0255-30 Aphena 30 tablets — AB FDA listed —
Lorazepam 1 mg 71610-0674-15 Aphena 15 tablets — AB FDA listed —
Lorazepam 1 mg 71610-0828-10 Aphena 10 tablets — AB FDA listed —
Lorazepam 1 mg 72789-0226-04 PD-Rx 4 tablets — AB FDA listed —
Lorazepam 1 mg 72789-0356-30 PD-Rx 30 tablets — AB FDA listed —
Lorazepam 1 mg 76420-0873-00 Asclemed 1000 tablets — AB FDA listed —
Lorazepam 1 mg 80425-0465-01 Advanced 30 tablets — AB FDA listed —
Lorazepam 1 mg 60760-0948-02 St. 2 tablets — AB FDA listed —
Lorazepam 1 mg 68788-4180-01 Preferred 100 tablets — AB FDA listed —
Lorazepam 1 mg 58118-0773-08 Clinical 30 tablets — AB FDA listed —
Lorazepam 1 mg 87441-0091-01 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

🏛️
2021
On the market since
Feb 2021
📍
2026
Currently FDA-listed
5 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 White
ShapeRound
ImprintU34
Size7 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAurolife Pharma LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA203572 (ANDA)
Labeler code13107
First marketedFeb 2021
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio27 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide ⚠️ Precautions 🍼 Nursing Mothers 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 212 words ▾

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including lorazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.

Before prescribing lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including lorazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.

Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage ( DOSAGE AND ADMINISTRATION and WARNINGS ).

🎯 Indications and Usage 55 words ▾

INDICATIONS AND USAGE Lorazepam tablets areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.

⏱️ Dosage and Administration 164 words ▾

DOSAGE AND ADMINISTRATION Lorazepam tablets are administeredorally. For optimalresults,dose,frequency of administration,andduration of therapyshould be individualizedaccording to patientresponse. To facilitatethis,0.5mg, 1 mg,and 2 mgtabletsareavailable.

The usualrange is 2 to 6 mg/daygivenindivideddoses, the largestdosebeingtakenbeforebedtime, but the dailydosagemayvaryfrom 1 to 10 mg/day. For anxiety,mostpatientsrequireaninitialdose of 2 to 3 mg/daygiventwotimes a day or threetimes a day. For insomnia due to anxiety or transientsituationalstress, a singledailydose of 2 to 4 mgmay be given,usuallyatbedtime.

For elderly or debilitatedpatients,aninitialdosage of 1 to 2 mg/day in divideddoses is recommended, to be adjustedasneededandtolerated. The dosageoflorazepam tablets should be increasedgraduallywhenneeded to helpavoidadverse effects.Whenhigherdosage is indicated, the eveningdoseshouldbeincreasedbefore the daytimedoses. Discontinuation or Dosage Reduction of Lorazepam Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam tablets or reduce the dosage.

If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence ).

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS Lorazepam is contraindicated in patientswith: hypersensitivity to benzodiazepines or to anycomponents of the formulation acutenarrow-angleglaucoma.

⚠️ Warnings ~2 min read ▾

WARNINGS Risks from Concomitant Use with Opioids Concomitantuse of benzodiazepines, including lorazepam,andopioidsmayresult in profoundsedation,respiratorydepression,coma,anddeath.Because of theserisks,reserveconcomitantprescribing of these drugs in patients for whomalternativetreatmentoptionsareinadequate. Observationalstudieshavedemonstratedthatconcomitantuse of opioid analgesicsandbenzodiazepinesincreases the risk of drug-relatedmortalitycompared to use of opioidsalone. If a decision is made to prescribelorazepam concomitantlywithopioids,prescribe the lowesteffectivedosagesandminimumdurations of concomitantuse,andfollowpatientsclosely for signsandsymptoms of respiratorydepression andsedation.

In patientsalreadyreceivinganopioidanalgesic,prescribe a lowerinitialdose of lorazepam thanindicated in theabsence of anopioidandtitratebased on clinicalresponse. If an opioid is initiated in a patientalreadytakinglorazepam,prescribe a lowerinitialdose of the opioidandtitratebased upon clinicalresponse. Advise both patientsandcaregiversabout the risks of respiratorydepressionandsedationwhenlorazepam is usedwithopioids.Advisepatients not to drive or operateheavymachineryuntil the effects of concomitantusewith the opioidhavebeendetermined(see PRECAUTIONS: Drug Interactions ).

Abuse, Misuse, and Addiction The use of benzodiazepines, including lorazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see DRUG ABUSE AND DEPENDENCE: Abuse ).

Before prescribing lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of lorazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of lorazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug.

If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of lorazepam ). Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.

Acute Withdrawal Reactions The continued use of benzodiazepines, including lorazepam, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: Dependence ). Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE: Dependence ).

Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. Lorazepam is not recommended for use in patients with a primary depressive disorder or psychosis. Use of benzodiazepines, including lorazepam, both… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 80 words ▾

ADVERSE REACTIONS Mostadversereactions to benzodiazepines,includingCNSeffectsandrespiratorydepression,aredose dependent,withmoresevereeffectsoccurringwithhighdoses. In a sample of about3500patientstreated for anxiety, the mostfrequentadversereaction to lorazepam wassedation(15.9%),followedbydizziness(6.9%),weakness(4.2%),andunsteadiness(3.4%). The incidence of sedationandunsteadinessincreasedwithage.

Otheradversereactions to benzodiazepines,includinglorazepam arefatigue,drowsiness,amnesia,memoryimpairment,confusion,disorientation,depression,unmasking of depression,disinhibition,euphoria,suicidalideation/attempt,ataxia,asthenia,extrapyramidalsymptoms,convulsions/seizures,tremor,vertigo,eyefunction/visualdisturbance(includingdiplopiaandblurredvision),dysarthria/slurred speech,change in libido,impotence,decreasedorgasm;headache,coma;respiratorydepression,apnea,worsening of sleepapnea,worsening of obstructivepulmonarydisease;gastrointestinalsymptoms includingnausea,change in appetite,constipation,jaundice,increase in bilirubin,increase in liver transaminases,increase in alkalinephosphatase;hypersensitivityreactions,anaphylactoidreactions;dermatologicalsymptoms,allergicskinreactions,alopecia;syndrome of inappropriateantidiuretic hormone(SIADH),hyponatremia;thrombocytopenia,agranulocytosis,pancytopenia;hypothermia;andautonomicmanifestations.

Paradoxicalreactions,includinganxiety,excitation,agitation,hostility,aggression,rage,sleepdisturbances/insomnia,sexualarousal,andhallucinationsmayoccur.Small decreases in blood pressure andhypotensionmayoccur but areusually not clinicallysignificant,probablybeingrelated to therelief of anxietyproducedbylorazepam. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

Drug Interactions The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.

Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. The benzodiazepines, including lorazepam, produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics. Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.

Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with valproate. Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance.

Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid. The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation. Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

🤰 Pregnancy ~2 min read ▾

Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including lorazepam, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome and Clinical Considerations ).

Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data) . The 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 risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia and sedation in neonates. Monitor neonates exposed to lorazepam during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems.

Monitor neonates exposed to lorazepam during pregnancy for signs of withdrawal. Manage these neonates accordingly (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome ). Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects.

Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. Animal Data Reproductive studies in animals were performed in mice, rats, and two strains of rabbits.

Occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia) were seen in drug-treated rabbits without relationship to dosage. Although all of these anomalies were not present in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg and higher, there was evidence of fetal resorption and increased fetal loss in rabbits which was not seen at lower doses.

🧓 Geriatric Use 114 words ▾

Geriatric Use Clinical studies of lorazepam generally were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects; however, the incidence of sedation and unsteadiness was observed to increase with age (see ADVERSE REACTIONS ). Age does not appear to have a significant effect on lorazepam kinetics (see CLINICAL PHARMACOLOGY ). Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered.

Greater sensitivity (e.g., sedation) of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, and lower doses may be sufficient in these patients (see DOSAGE AND ADMINISTRATION ).

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur.

In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Abuse, Misuse , and Addiction ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.

In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency.

The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage.

See the flumazenil injection Prescribing Information. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology 140 words ▾

CLINICAL PHARMACOLOGY Studies in healthyvolunteersshowthat in singlehighdoseslorazepam has a tranquilizingaction on the centralnervoussystemwith no appreciableeffect on the respiratory or cardiovascularsystems. Lorazepam is readilyabsorbedwithanabsolutebioavailability of 90%.Peakconcentrations in plasmaoccurapproximately 2 hoursfollowingadministration. The peakplasmalevel of lorazepam from a 2 mgdose is approximately 20 ng/mL.

The meanhalf-life of unconjugatedlorazepam inhumanplasma is about 12 hoursand for its majormetabolite,lorazepam glucuronide,about 18 hours.Atclinicallyrelevantconcentrations,lorazepam isapproximately 85% bound to plasmaproteins.Lorazepam is rapidlyconjugatedatits3-hydroxy group into lorazepam glucuronidewhich is thenexcreted in the urine. Lorazepam glucuronidehas no demonstrablecentralnervoussystem(CNS)activityinanimals. The plasmalevels of lorazepam areproportionaltothedosegiven.

There is no evidence of accumulation of lorazepam onadministrationup to 6 months. Studiescomparing young andelderlysubjectshaveshownthatadvancingagedoes not have a significanteffect on the pharmacokinetics of lorazepam.However, in one studyinvolvingsingleintravenousdoses of 1.5 to 3 mg of lorazepam Injection,meantotalbodyclearance of lorazepam decreasedby20% in 15 elderlysubjects of 60 to 84 years of agecompared to that in 15youngersubjects of 19 to 38 years of age.

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

HOW SUPPLIED Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg, white to off-white, round, flat-faced beveled edge tablets debossed with ‘U32’ on one side and plain on the other side. Bottles of 10 tablets NDC 13107-083-11 Bottles of 100 tablets NDC 13107-083-01 Bottles of 500 tablets NDC 13107-083-05 Bottles of 1000 tablets NDC 13107-083-99 1 mg, white to off-white, round, flat-faced beveled edge tablets debossed with ‘U33’ on one side and bisect on the other side. Bottles of 10 tablets NDC 13107-084-11 Bottles of 100 tablets NDC 13107-084-01 Bottles of 500 tablets NDC 13107-084-05 Bottles of 1000 tablets NDC 13107-084-99 2 mg, white to off-white, round, flat-faced beveled edge tablets debossed with a bisect separating “U” and “34” on one side and “2” on other side.

Bottles of 10 tablets NDC 13107-085-11 Bottles of 100 tablets NDC 13107-085-01 Bottles of 500 tablets NDC 13107-085-05 Bottles of 1000 tablets NDC 13107-085-99 Keep bottles tightly closed. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as described in the USP. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 06/2023 Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

📋 Description 44 words ▾

DESCRIPTION Lorazepam USP,anantianxietyagent,has the chemicalformula,7-chloro-5-( o -chlorophenyl)-1,3­-dihydro-3-hydroxy-2 H -1,4-benzodiazepin-2-one: It is a nearlywhitepowderalmostinsoluble in water.Eachlorazepam tablet, USP to be takenorally,contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactiveingredientspresent are anhydrous lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. Chemical Structure

💬 Information for Patients ~2 min read ▾

Information for Patients Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when lorazepam is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see WARNINGS: Risks from Concomitant Use of Opioids and PRECAUTIONS: Drug Interactions ).

Abuse, Misuse, and Addiction Inform patients that the use of lorazepam even at recommended doses, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS: Abuse Misuse, and Addiction and DRUG ABUSE AND DEPENDENCE ).

Withdrawal Reactions Inform patients that the continued use of lorazepam may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of lorazepam may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of lorazepam may require a slow taper (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE ).

Pregnancy Advise pregnant females that use of lorazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome and PRECAUTIONS: Pregnancy ). Instruct patients to inform their healthcare provider if they are pregnant. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lorazepam during pregnancy (see PRECAUTIONS: Pregnancy ).

Nursing Instruct patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed. Instruct breastfeeding patients using lorazepam to monitor infants for excessive sedation, poor feeding and poor weight gain, and to seek medical attention if they notice these signs (see PRECAUTIONS: Nursing Mothers ).

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Lorazepam Tablets, USP CIV (lor-A-ze-pam) What is the most important information I should know about lorazepam tablets? Lorazepam tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.

Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking lorazepam tablets with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including lorazepam tablets which can lead to overdose and serious side effects including coma and death.

Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including lorazepam tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.

You can develop an addiction even if you take lorazepam tablets exactly as prescribed by your healthcare provider. Take lorazepam tablets exactly as your healthcare provider prescribed. Do not share your lorazepam tablets with other people.

Keep lorazepam tablets in a safe place and away from children. Physical dependence and withdrawal reactions. Lorazepam tablets can cause physical dependence and withdrawal reactions.

Do not suddenly stop taking lorazepam tablets. Stopping lorazepam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.

Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

Do not take more lorazepam tablets than prescribed or take lorazepam tablets for longer than prescribed. What are lorazepam tablets? Lorazepam tablets are a prescription medicine used: to treat anxiety disorders for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression Lorazepam tablets are a federal controlled substance (CIV) because it contains lorazepam that can be abused or lead to dependence.

Keep lorazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away lorazepam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

It is not known if lorazepam tablets are safe and effective for use in children less than 12 years of age. It is not known if lorazepam tablets are safe and effective for use for longer than 4 months. Do not take lorazepam tablets if you: are allergic to lorazepam, other benzodiazepines, or any of the ingredients in lorazepam tablets.

See the end of this Medication Guide for a complete list of ingredients in lorazepam tablets. Before you… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS In patientswithdepression, a possibility for suicideshould be borne in mind;benzodiazepinesshould not be used in suchpatientswithoutadequateantidepressanttherapy. Lorazepam should be usedwithcaution in patientswithcompromisedrespiratoryfunction(e.g.,COPD,sleepapneasyndrome). Elderly or debilitatedpatientsmay be moresusceptible to the sedativeeffects of lorazepam.Therefore,thesepatientsshould be monitoredfrequentlyandhavetheirdosageadjustedcarefullyaccordingto patientresponse; the initialdosageshould not exceed 2 mg.

Paradoxicalreactionshavebeenoccasionallyreportedduringbenzodiazepineuse.Suchreactionsmay be morelikelytooccur in childrenand the elderly.Shouldtheseoccur,use of the drugshould be discontinued. The usualprecautions for treatingpatientswithimpairedrenal or hepaticfunctionshould be observed.As withallbenzodiazepines, the use of lorazepam mayworsenhepaticencephalopathy;therefore,lorazepam should be usedwithcaution in patientswithseverehepaticinsufficiencyand/orencephalopathy.Dosage for patientswithseverehepaticinsufficiencyshould be adjustedcarefullyaccording to patientresponse;lowerdosesmay be sufficient in suchpatients.

In patientswheregastrointestinal or cardiovasculardisorderscoexistwithanxiety, it shouldbenotedthat lorazepam has not beenshown to be of significantbenefit in treating the gastrointestinal or cardiovascular component. Esophagealdilationoccurred in ratstreatedwithlorazepam formorethan 1 yearat 6 mg/kg/day. The no-effectdose was 1.25 mg/kg/day(approximately 6 times the maximumhumantherapeuticdose of 10 mg/day).

The effect was reversibleonlywhen the treatmentwaswithdrawnwithin 2 months of first observationof the phenomenon. The clinicalsignificance of this is unknown.However,use of lorazepam forprolongedperiodsandingeriatricpatientsrequirescaution,andthereshould be frequentmonitoring for symptoms of upperGIdisease. Safetyandeffectiveness of lorazepam in children of lessthan 12 yearshave not beenestablished.

Information for Patients Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when lorazepam is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see WARNINGS: Risks from Concomitant Use of Opioids and PRECAUTIONS: Drug Interactions ).

Abuse, Misuse, and Addiction Inform patients that the use of lorazepam even at recommended doses, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS: Abuse Misuse, and Addiction and DRUG ABUSE AND DEPENDENCE ).

Withdrawal Reactions Inform patients that the continued use of lorazepam may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of lorazepam may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of lorazepam may require a slow taper (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE ).

Pregnancy Advise pregnant females that use of lorazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, r… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 93 words ▾

Nursing Mothers Risk Summary Lorazepam is present in breast milk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. The effects of lorazepam on milk production are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lorazepam and any potential adverse effects on the breastfed infant from lorazepam or from the underlying maternal condition. Clinical Considerations Infants exposed to lorazepam through breast milk should be monitored for sedation, poor feeding and poor weight gain.

🔒 Drug Abuse and Dependence ~2 min read ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Lorazepam tablets contains lorazepam, a Schedule IV controlled substance. Abuse Lorazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.

Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death.

Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS: Abuse, Misuse, and Addiction ). The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.

The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Dependence Physical Dependence Lorazepam may produce physical dependence from continued therapy.

Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS: Dependence and Withdrawal Reactions ).

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of lorazepam and WARNINGS ). Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor.

More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depressi… [Excerpted — this section continues on DailyMed.]

🔒 Controlled Substance 11 words ▾

Controlled Substance Lorazepam tablets contains lorazepam, a Schedule IV controlled substance.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 24 words ▾

Carcinogenesis and Mutagenesis No evidence of carcinogenic potential emerged in rats during an 18-month study with lorazepam. No studies regarding mutagenesis have been performed.

📄 Package Label / Principal Display Panel 129 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5 mg 100 Tablets Bottle) NDC 13107-083-01 Rx only Lorazepam Tablets, USP 0.5 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5 mg 100 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg 100 Tablets Bottle) NDC 13107-084-01 Rx only Lorazepam Tablets, USP 1 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg 100 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg 100 Tablets Bottle) NDC 13107-085-01 Rx only Lorazepam Tablets, USP 2 mg CIV PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg 100 Tablets Bottle)

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
500 tablets13107-0084-05 118,742 Rx · $943,858
1000 tablets13107-0084-99 28,509 Rx · $287,887
100 tablets13107-0084-01 733 Rx · $5,674
10 tablets this page13107-0084-11 No Medicaid data
10 tablets13107-0084-10 No Medicaid data
Drug total (last 4 qtrs): 147,984 Rx · 6,633,408 units · $1,237,419 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Lorazepam — the program that covers self-administered drugs. 17 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 Lorazepam. 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
$17.62M
Claims incl. refills
1.9M
Beneficiaries
1M
Spend / beneficiary
$17.50
Spend / claim
$9.14
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 Aurolife Pharma 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 4 other package presentations of this same product, including 10 tablets (13107-0084-10), 100 tablets (13107-0084-01), 500 tablets (13107-0084-05). 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?
Aurolife Pharma 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.
← 13107-0083-01 · Aurolife 13107-0085-01 · Aurolife →
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.