NDC 71872-7259-01 — Diazepam 5 mg/mL Injection, Solution

🆔 Identity & classification

FDA NDC (as labeled) 71872-7259-1

Product NDC 71872-7259

11-digit billing NDC 71872725901

RxCUI 309845

UNII Q3JTX2Q7TU

Application # ANDA211998

SPL Set ID c8e95ff5-c177-1ec3-e053-2995a90a6d78

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 2020-07-01

Route INTRAMUSCULAR, INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance DIAZEPAM

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 71872-7259-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71872-7259-01. 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.

🏭 Manufacturer & labeler

LabelerMedical Purchasing Solutions, LLC

Application holderREGCON HOLDINGS LLC

FDA applicationANDA211998 (ANDA)

Labeler code71872

First marketedJul 2020

DEA scheduleCIV

Product typeHuman Prescription Drug

Portfolio250 products on file

🔎 All NDCs from Medical Purchasing Solutions, LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist

📖 Read our full Diazepam guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Diazepam — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Diazepam (244 interactions) — ranked by severity →

1

Nutrient depletion considerations

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

VITAMIN K Insignificant Depletion

🧪 Full Diazepam 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.

🧪 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 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII 8SKN0B0MIM
Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.

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.

💲 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 system	Per mL	Per 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.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Diazepam 5 mg/mL 00404-9762-10	Henry	1 vial	—	—	FDA listed	—
Diazepam 5 mg/mL 00404-9848-10	Henry	1 vial	—	AP	FDA listed	—
Diazepam 5 mg/mL 00409-3213-12	Hospira,	10 vials	—	AP	FDA listed	—
Diazepam 5 mg/mL 00641-6243-10	Hikma	10 vials	—	—	FDA listed	—
Diazepam 5 mg/mL 69339-0137-95	Natco	5 vials	—	AP	Discontinued	—
Diazepam 5 mg/mLthis 71872-7259-01	Medical	1 vial	—	AP	FDA listed	—
Diazepam 5 mg/mL 71872-7260-01	Medical	1 vial	—	AP	FDA listed	—
Diazepam 5 mg/mL 00409-1273-32	Hospira,	10 cartridges	—	AP	FDA listed	—
Diazepam 5 mg/mL 00404-9769-02	Henry	1 syringe	—	AP	FDA listed	—
Diazepam 5 mg/mL 00641-6244-10	Hikma	10 syringes	—	AP	FDA listed	—
Diazepam 5 mg/mL 25021-0618-72	Sagent	10 syringes	—	AP	FDA listed	—
Diazepam 5 mg/mL 00641-6283-25	Hikma	25 vials	—	—	FDA listed	—
Diazepam 5 mg/mL 72572-0175-10	Civica,	10 syringes	—	AP	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

🏛️

2020

On the market since

Jul 2020

📍

2026

Currently FDA-listed

6 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

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

Where does this data come from?

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

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

Medicare Part D (outpatient prescription) spending for Diazepam — the program that covers self-administered drugs. 16 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 Diazepam. 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

$4.44M

Claims incl. refills

704.6K

Beneficiaries

418.2K

Spend / beneficiary

$10.63

Spend / claim

$6.31

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Toxicity To Various Agents9,514

Drug Abuse7,212

Nausea6,288

Fatigue5,838

Pain5,269

Anxiety5,086

Somnolence5,077

Age at onset

Neonate288

Infant115

Child301

Adolescent354

Adult9,363

Elderly3,178

Reporter sex

Male · 42%

Female · 57%

Unknown · 1%

Serious outcomes

Hospitalization42,064

Death22,957

Life-threatening8,335

Disabling4,084

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71872-7259-01 You're viewing this	1 VIAL, MULTI-DOSE in 1 BAG (71872-7259-1) / 10 mL in 1 VIAL, MULTI-DOSE	2021-07-07	Active

🧭 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)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 71872-7259-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71872-7259-01, written without dashes as 71872725901. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 71872-7259-01, the first segment (71872) is the labeler code FDA assigned to Medical Purchasing Solutions, LLC; the middle segment (7259) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Medical Purchasing Solutions, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Medical Purchasing Solutions, 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.

📄 Full prescribing information FDA SPL

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

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🚨 Boxed Warning 66 words ▾

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see WARNINGS , PRECAUTIONS; Drug Interactions ]. Reserve concomitant prescribing of these drugs for use in 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.

🎯 Indications and Usage 198 words ▾

INDICATIONS AND USAGE Diazepam is indicated for the management of anxiety disorders or for 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. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures. (See WARNINGS .) Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Injectable diazepam is a useful adjunct in status epilepticus and severe recurrent convulsive seizures.

Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg intramuscular or intravenous, depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required.

(See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS .) For dosage in infants above the age of 30 days and children, see the specific indications below.

When intravenous use is indicated, facilities for respiratory assistance should be readily available. Intramuscular: Diazepam Injection, USP should be injected deeply into the muscle. Intravenous use: (See WARNINGS , particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given.

Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation. Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion container.

If it is not feasible to administer diazepam directly intravenous, it may be injected slowly through the infusion tubing as close as possible to the vein insertion. Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see PRECAUTIONS ).

NOTE: Solution may appear colorless to light yellow. USUAL ADULT DOSAGE DOSAGE RANGE IN CHILDREN (Intravenous administration should be made slowly) Moderate Anxiety Disorders and Symptoms of Anxiety 2 mg to 5 mg, intramuscular or intravenous Repeat in 3 to 4 hours, if necessary. Severe Anxiety Disorders and Symptoms of Anxiety 5 mg to 10 mg, intramuscular or intravenous Repeat in 3 to 4 hours, if necessary.

Acute Alcohol Withdrawal: As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. 10 mg, intramuscular or intravenous initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures.

Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures. Titrate intravenous dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure.

Generally 10 mg or less is adequate, but up to 20 mg intravenous may be given, particularly when concomitant narcotics are omitted. If intravenous cannot be used, 5 mg to 10 mg intramuscular approximately 30 minutes prior to the procedure. Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.

5 mg to 10 mg, intramuscular or intravenous initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required. For tetanus in infants over 30 days of age, 1 mg to 2 mg intramuscular or intravenous, slowly, repeated every 3 to 4 hours as necessary.

In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available. Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the intravenous route is by far preferred.

This injection should be administered slowly. However, if intravenous administration is impossible, the intramuscular route may…

⛔ Contraindications 28 words ▾

CONTRAINDICATIONS Injectable diazepam is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; and open angle glaucoma unless patients are receiving appropriate therapy.

⚠️ Warnings ~3 min read ▾

WARNINGS Concomitant use of benzodiazepines, including diazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

If a decision is made to prescribe diazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when diazepam is used with opioids [see PRECAUTIONS; Drug Interactions ]. When used intravenously, the following procedures should be undertaken to reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, and, rarely, vascular impairment; the solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given; do not use small veins, such as those on the dorsum of the hand or wrist; extreme care should be taken to avoid intra-arterial administration or extravasation.

Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion container. If it is not feasible to administer diazepam directly intravenous, it may be injected slowly through the infusion tubing as close as possible to the vein insertion. Extreme care must be used in administering Diazepam Injection, particularly by the intravenous route, to the elderly, to very ill patients and to those with limited pulmonary reserve because of the possibility that apnea and/or cardiac arrest may occur.

Concomitant use of barbiturates, alcohol or other central nervous system depressants increases depression with increased risk of apnea. Resuscitative equipment including that necessary to support respiration should be readily available. When diazepam is used with a narcotic analgesic, the dosage of the narcotic should be reduced by at least one-third and administered in small increments.

In some cases the use of a narcotic may not be necessary. Diazepam Injection should not be administered to patients in shock, coma, or in acute alcoholic intoxication with depression of vital signs. As is true of most CNS-acting drugs, patients receiving diazepam should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.

Tonic status epilepticus has been precipitated in patients treated with intravenous diazepam for petit mal status or petit mal variant status. Usage in Pregnancy: An increased risk of congenital malformations associated with the use of minor tranquilizers (diazepam, meprobamate and chlordiazepoxide) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided.

The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. In humans, measurable amounts of diazepam were found in maternal and cord blood, indicating placental transfer of the drug.

Until additional information is available, diazepam injection is not recommended for obstetrical use. Pediatric Use: Efficacy and safety of parenteral diazepam has not been established in the neonate (30 days or less of age). Prolonged central nervous system depression has been observed in neonates, apparently due to inability to biotransform diazepam into inactive metaboli…

🤒 Adverse Reactions 165 words ▾

ADVERSE REACTIONS Side effects most commonly reported were drowsiness, fatigue and ataxia; venous thrombosis and phlebitis at the site of injection. Other adverse reactions less frequently reported include: CNS: confusion, depression, dysarthria, headache, hypoactivity, slurred speech, syncope, tremor, vertigo. G.I.: constipation, nausea.

G.U.: incontinence, changes in libido, urinary retention. Cardiovascular: bradycardia, cardiovascular collapse, hypotension. EENT: blurred vision, diplopia, nystagmus.

Skin: urticaria, skin rash. Other: hiccups, changes in salivation, neutropenia, jaundice. Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported; should these occur, use of the drug should be discontinued.

Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known significance. In peroral endoscopic procedures, coughing, depressed respiration, dyspnea, hyperventilation, laryngospasm and pain in throat or chest have been reported. Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy.

🧬 Clinical Pharmacology 95 words ▾

CLINICAL PHARMACOLOGY In animals, diazepam appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. Diazepam, unlike chlorpromazine and reserpine, has no demonstrable peripheral autonomic blocking action, nor does it produce extrapyramidal side effects; however, animals treated with diazepam do have a transient ataxia at higher doses. Diazepam was found to have transient cardiovascular depressor effects in dogs.

Long-term experiments in rats revealed no disturbances of endocrine function. Injections into animals have produced localized irritation of tissue surrounding injection sites and some thickening of veins after intravenous use.

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

HOW SUPPLIED Diazepam Injection, USP 50 mg/10 mL is a clear, colorless to slightly yellow solution supplied in 10 mL multiple-dose vial. Unit of Sale Concentration Each NDC 69339-137-10 Carton of 10 50 mg/10 mL (5 mg/mL) NDC 69339-137-01 NDC 69339-137-05 Carton of 5 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. ANIMAL PHARMACOLOGY Oral LD 50 of diazepam is 720 mg/kg in mice and 1240 mg/kg in rats.

Intraperitoneal administration of 400 mg/kg to a monkey resulted in death on the sixth day. Reproduction Studies: A series of rat reproduction studies was performed with diazepam in oral doses of 1, 10, 80 and 100 mg/kg given for periods ranging from 60228 days prior to mating. At 100 mg/kg there was a decrease in the number of pregnancies and surviving offspring in these rats.

These effects may be attributable to prolonged sedative activity, resulting in lack of interest in mating and lessened maternal nursing and care of the young. Neonatal survival of rats at doses lower than 100 mg/kg was within normal limits. Several neonates, both controls and experimentals, in these rat reproduction studies showed skeletal or other defects.

Further studies in rats at doses up to and including 80 mg/kg/day did not reveal significant teratological effects on the offspring. Rabbits were maintained on doses of 1, 2, 5 and 8 mg/kg from day 6 through day 18 of gestation. No adverse effects on reproduction and no teratological changes were noted.

07/2019 Manufactured by: Corden Pharma S.p.A. Viale dellIndustria, 3 20867 Caponago (MB), Italy Distributed by: DASH Pharmaceuticals, LLC 2 Park Way Upper Saddle River, NJ 07458

📋 Description 85 words ▾

DESCRIPTION Diazepam Injection, USP is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. Each milliliter (mL) contains 5 mg diazepam; 40% propylene glycol; 10% alcohol; 5% sodium benzoate and benzoic acid added as buffers; and 1.5% benzyl alcohol added as a preservative. pH 6.6 (6.2 to 6.9). Note: Solution may appear colorless to light yellow.

Diazepam is a benzodiazepine derivative chemically designated as 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with the following molecular structure: Molecular Structure of Diazepam Injection

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

sedative: A substance with a calming effect that can also cause drowsiness.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diplopia: Double vision, or seeing two images of a single object.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysarthria: Slurred or slow speech caused by weakness or poor control of the muscles used for speaking.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

extravasation: The accidental leaking of an injected medicine out of the vein into the surrounding tissue, which can cause pain, swelling, or tissue damage.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intramuscular: An injection given deep into a muscle; often written as IM.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

laryngospasm: A sudden spasm of the vocal cords that briefly closes the voice box and makes it hard to breathe or speak.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

status epilepticus: A seizure that lasts a long time, or repeated seizures without recovery in between, which is a medical emergency.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urinary retention: Being unable to empty the bladder fully or at all.

urticaria: Raised, itchy welts on the skin, commonly called hives.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

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