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Diphenhydramine 50 mg/mL Injection, Solution, 25 vials — NDC 83634-0781-01 package photo

Diphenhydramine 50 mg/mL Injection, Solution, 25 vials

by Avenacy, LLC · 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-781-01) / 1 mL in 1 VIAL, SINGLE-DOSE (83634-781-41)
NDC 83634-0781-01
🏷️ FDA NDC (as labeled) 83634-781-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 83634-781-01
Product NDC 83634-781
11-digit billing NDC 83634078101
NCPDP billing unit ML — per mL (volume)
RxCUI 1723740
UNII TC2D6JAD40
Application # ANDA205336
SPL Set ID 00f862aa-6917-45c7-b6aa-1bebb0a45e14
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-01
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DIPHENHYDRAMINE HYDROCHLORIDE
GPI-14 41200030102010
GCN Seq No 011590
GCN 46013
HICL code 004480
Ingredient (HICL) Diphenhydramine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name DIPHENHYDRAMINE 50 MG/ML VIAL
FDB brand name Diphenhydramine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 83634-781-01 — 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 → 83634-0781-01. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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

LabelerAvenacy, LLC
Application holderAVET LIFESCIENCES PRIVATE LTD
FDA applicationANDA205336 (ANDA)
Labeler code83634
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio29 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.

🩺 Clinical

Label name DIPHENHYDRAMINE 50 MG/ML VIAL Ingredient Diphenhydramine Hcl
📖 What it is MedlinePlus · NLM

Diphenhydramine injection is used to treat allergic reactions, motion sickness and to control abnormal movements in people who have Parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Diphenhydramine injection is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
  • What exactly does diphenhydramine treat?
  • Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
  • It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
📖 Read our full Diphenhydramine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

2 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.934 $23.34 / 25 ml
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.
Medicare Part B allowsASP · J1200 $0.752 / J1200 unit —
NADAC price history (per mL) — tap or hover for the price & month
Aug 2026 $0.934 $0.934
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)83634-781-01
11-digit billing NDC83634-0781-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1200
DescriptorINJECTION, DIPHENHYDRAMINE HCL, UP TO 50 MG
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diphenhydramine Hydrochloride 50 mg/mL 23155-0263-31 Heritage 1 vial $0.790 AP FDA listed save 15%
Diphenhydramine hydrochloride 50 mg/mL 00641-6282-25 Hikma 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mL 23155-0264-41 Heritage 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mL 25021-0481-01 Sagent 25 vials $0.934 AP Availability likely —
Diphenhydramine 50 mg/mL 42571-0337-87 Micro 25 vials $0.934 AP Availability likely —
Diphenhydramine 50 mg/mL 63323-0664-01 Fresenius 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mL 72485-0101-25 Armas 25 vials $0.934 AP Availability likely —
Diphenhydramine 50 mg/mLthis 83634-0781-01 Avenacy, 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mL 00641-0376-25 Hikma 25 vials $0.934 AP Availability likely —
Diphenhydramine Hydrochloride 50 mg/mL 00404-9851-01 Henry 1 vial — AP FDA listed —
Diphenhydramine 50 mg/mL 42571-0169-55 Micro 10 ampules — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 51662-1219-01 HF 1 ml — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 51662-1348-01 HF 1 ml — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 51662-1374-01 HF 1 ml — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 55154-9363-05 Cardinal 5 vials — AP FDA listed —
Diphenhydramine 50 mg/mL 65219-0820-01 Fresenius 25 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 68083-0611-25 Gland 25 vials — AP FDA listed —
Diphenhydramine hydrochloride 50 mg/mL 70518-4455-00 REMEDYREPACK 25 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 70518-4536-00 REMEDYREPACK 25 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 71872-7005-01 Medical 1 vial — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 71872-7180-01 Medical 1 vial — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 71872-7373-01 Medical 1 vial — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 84549-0101-25 ProPharma 1 ml — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 55154-5102-05 Cardinal 5 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 70518-1082-01 REMEDYREPACK 25 vials — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 76045-0235-10 Fresenius 1 syringe — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 42571-0511-56 Micro 1 vial — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 76045-0102-10 Fresenius 1 syringe — AP FDA listed —
Diphenhydramine Hydrochloride 50 mg/mL 85766-0253-25 Sportpharm 25 vials — 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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🔬 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 DIPHENHYDRAMINE (this brand).

Top reported reactions

Fatigue7,934
Headache7,601
Nausea6,748
Pain6,599
Infusion Related Reaction5,711
Arthralgia5,403
Toxicity To Various Agents5,094

Age at onset

Neonate84
Infant116
Child1,275
Adolescent905
Adult11,190
Elderly4,461

Reporter sex

80,878 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization26,478
Death15,219
Life-threatening4,233
Disabling1,672
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,889 0
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 NDCDescription Marketing startStatus
83634-0781-01 You're viewing this 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-781-01) / 1 mL in 1 VIAL, SINGLE-DOSE (83634-781-41) 2025-09-01 Active

📄 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 130 words ▾

INDICATIONS AND USAGE Diphenhydramine hydrochloride injection, USP is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. Antihistaminic For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.

Motion Sickness For active treatment of motion sickness. Antiparkinsonism For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases of parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

⏱️ Dosage and Administration 126 words ▾

DOSAGE AND ADMINISTRATION THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride injection, USP is indicated when the oral form is impractical. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Pediatric Patients, Other Than Premature Infants and Neonates 5 mg/kg/24 hours or 150 mg/m 2 /24 hours. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly.

Adults 10 mg to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly; 100 mg if required; maximum daily dosage is 400 mg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 87 words ▾

CONTRAINDICATIONS Use in Neonates or Premature Infants This drug should not be used in neonates or premature infants. Use in Nursing Mothers Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Use as a Local Anesthetic Because of the risk of local necrosis, this drug should not be used as a local anesthetic.

Antihistamines are also Contraindicated in the Following Conditions Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

⚠️ Warnings 100 words ▾

WARNINGS Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder-neck obstruction. Local necrosis has been associated with the use of subcutaneous or intradermal use of intravenous diphenhydramine. Use in Pediatric Patients In pediatric patients, especially, antihistamines in overdosage may cause hallucinations, convulsions or death.

As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young pediatric patient, particularly, they may produce excitation. Use in the Elderly (approximately 60 years or older) Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.

🤒 Adverse Reactions 114 words ▾

ADVERSE REACTIONS The most frequent adverse reactions are italicized. General Urticaria; drug rash; anaphylactic shock; photosensitivity; excessive perspiration; chills; dryness of mouth, nose and throat. Cardiovascular System Hypotension, headache, palpitations, tachycardia, extrasystoles.

Hematologic System Hemolytic anemia, thrombocytopenia, agranulocytosis. Nervous System Sedation, sleepiness, dizziness, disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions. Gastrointestinal System Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation.

Genitourinary System Urinary frequency, difficult urination, urinary retention, early menses. Respiratory System Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness. To report SUSPECTED ADVERSE REACTIONS, contact Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 28 words ▾

Drug Interactions Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.) MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

🤰 Pregnancy 71 words ▾

Pregnancy Teratogenic Effects Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 46 words ▾

Pediatric Use Diphenhydramine should not be used in neonates and premature infants (see CONTRAINDICATIONS ). Diphenhydramine may diminish mental alertness, or in the young pediatric patient, cause excitation. Overdosage may cause hallucinations, convulsions or death (see WARNINGS and OVERDOSAGE ). See also DOSAGE AND ADMINISTRATION section.

🆘 Overdosage 48 words ▾

OVERDOSAGE Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing, and gastrointestinal symptoms may also occur. Stimulants should not be used. Vasopressors may be used to treat hypotension.

🧬 Clinical Pharmacology 81 words ▾

CLINICAL PHARMACOLOGY Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. Diphenhydramine hydrochloride in the injectable form has a rapid onset of action.

Diphenhydramine is widely distributed throughout the body, including the CNS. A portion of the drug is excreted unchanged in the urine, while the rest is metabolized via the liver. Detailed information on the pharmacokinetics of diphenhydramine hydrochloride injection, USP is not available.

📦 How Supplied / Storage and Handling 103 words ▾

HOW SUPPLIED Diphenhydramine Hydrochloride Injection, USP 50 mg per mL is a clear, colorless solution supplied as follows: NDC Diphenhydramine Hydrochloride Injection, USP Package Factor 83634-781-01 50 mg per mL Single-Dose Vial 25 vials per carton Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Keep covered in carton until time of use. Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. AVENACY Mfd. for Avenacy Schaumburg, IL 60173 (USA) Made in India ©2025 Avenacy Revised: May 2025

📦 Storage and Handling 67 words ▾

Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Keep covered in carton until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. AVENACY Mfd. for Avenacy Schaumburg, IL 60173 (USA) Made in India ©2025 Avenacy Revised: May 2025

📋 Description 88 words ▾

DESCRIPTION Diphenhydramine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg in Water for Injection. pH 4.0 to 6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride.

The structural formula is as follows: C 17 H 21 NO • HCl MW 291.82 Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol. Structural Formula

💬 Information for Patients 44 words ▾

Information for Patients Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol. Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances, machinery, etc.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83634-0779-02 · Avenacy, 83634-0801-05 · Avenacy →
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.