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Diphenhydramine 50 mg/mL Injection, Solution, 25 vials — NDC 63323-0664-16 package photo

Diphenhydramine 50 mg/mL Injection, Solution, 25 vials

by Fresenius Kabi USA, LLC · 25 VIAL in 1 TRAY (63323-664-16) / 1 mL in 1 VIAL (63323-664-41)
NDC 63323-0664-16
🏷️ FDA NDC (as labeled) 63323-664-16 billing pads the product segment with a zero
This package
Contains25 vials Cost per mL$0.9336 NADAC Per package$23.34 / 25 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $181.58/unit — full pricing hub ↓
Also comes in: 25 vials 63323-0664-01
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 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) 63323-664-16
Product NDC 63323-664
11-digit billing NDC 63323066416
NCPDP billing unit ML — per mL (volume)
RxCUI 1723740
UNII TC2D6JAD40
UPC 0363323664411
Application # ANDA040466
SPL Set ID fc574e74-1fdc-4a61-a1ed-492ae43faed2
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 2002-08-01
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DIPHENHYDRAMINE HYDROCHLORIDE
GPI-14 41200030102010
GPI class diphenhydrAMINE HCl
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 63323-664-16 — 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 → 63323-0664-16. 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

LabelerFresenius Kabi USA, LLC
Application holderAPP PHARMACEUTICALS LLC
FDA applicationANDA040466 (ANDA)
Labeler code63323
First marketedAug 2002
Product typeHuman Prescription Drug
Portfolio554 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 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 $181.58 $4,539.57 / 25 ml
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
Nov 2021 Aug 2022 Jan 2026 Aug 2026 $1.047 $0.855
▼ Down 11% over the last 21 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)63323-664-16
11-digit billing NDC63323-0664-16
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 / pkg25 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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/mLthis 63323-0664-16 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/mL 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

🏛️
2002
On the market since
Aug 2002
📍
2026
Currently FDA-listed
24 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 63323-0664-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
12.9K
Units reimbursed last 4 qtrs
22K
Gross reimbursed last 4 qtrs
$3.99M
Avg / prescription
$309.09
Avg / unit
$181.58
Latest quarter Q4 2025
4KRx
Medicaid pays / mL
$181.58
gross reimbursed
vs
NADAC / mL
$0.9336
acquisition cost
=
Spread
+$180.65
+19350% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
89% MCO
Fee-for-service · 1,364 Rx Managed care · 11,537 Rx
State Medicaid map
Alaska: no data reported AK Maine: 11 units · 0.8 per 100k residents ME Washington: 12 units · 0.2 per 100k residents WA Idaho: no data reported ID Montana: 15 units · 1.3 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,042 units · 5.3 per 100k residents NY Vermont: no data reported VT New Hampshire: 471 units · 33.6 per 100k residents NH Oregon: no data reported OR Nevada: 1,888 units · 59.1 per 100k residents NV Wyoming: no data reported WY South Dakota: 224 units · 24.4 per 100k residents SD Iowa: 155 units · 4.8 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 2,239 units · 19.0 per 100k residents OH Pennsylvania: 2,543 units · 19.6 per 100k residents PA New Jersey: 464 units · 5.0 per 100k residents NJ Massachusetts: 448 units · 6.4 per 100k residents MA California: 2,523 units · 6.5 per 100k residents CA Utah: 24 units · 0.7 per 100k residents UT Colorado: 14 units · 0.2 per 100k residents CO Nebraska: 93 units · 4.7 per 100k residents NE Missouri: 14 units · 0.2 per 100k residents MO Kentucky: 490 units · 10.8 per 100k residents KY West Virginia: 235 units · 13.3 per 100k residents WV Virginia: 81 units · 0.9 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 720 units · 9.7 per 100k residents AZ New Mexico: 46 units · 2.2 per 100k residents NM Kansas: 219 units · 7.4 per 100k residents KS Arkansas: no data reported AR Tennessee: 26 units · 0.4 per 100k residents TN North Carolina: 5,650 units · 52.1 per 100k residents NC South Carolina: 375 units · 7.0 per 100k residents SC Delaware: no data reported DE Oklahoma: 26 units · 0.6 per 100k residents OK Louisiana: no data reported LA Mississippi: 201 units · 6.8 per 100k residents MS Alabama: 20 units · 0.4 per 100k residents AL Georgia: 58 units · 0.5 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 824 units · 2.7 per 100k residents TX Florida: 810 units · 3.6 per 100k residents FL
Units reimbursed · per 100k residents
0.259.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nevada 59.1 /100k
2 North Carolina 52.1 /100k
3 New Hampshire 33.6 /100k
4 South Dakota 24.4 /100k
5 Pennsylvania 19.6 /100k
6 Ohio 19.0 /100k
7 West Virginia 13.3 /100k
8 Kentucky 10.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.
25 vials63323-0664-01 103,336 Rx · $5,925,893
25 vials this page63323-0664-16 12,901 Rx · $3,987,555
Drug total (last 4 qtrs): 116,237 Rx · 169,899 units · $9,913,448 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Per unit Per pack Marketing startStatus
63323-0664-01 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-664-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-664-00) $0.9336 / mL $23.34 2002-08-01 Active
63323-0664-16 You're viewing this 25 VIAL in 1 TRAY (63323-664-16) / 1 mL in 1 VIAL (63323-664-41) $0.9336 / mL $23.34 2002-08-01 Active

This pack effectively ties for the lowest per-mL cost of the 2 priced pack sizes ($0.9336 NADAC).

This pack accounts for about 11% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 63323-0664-16?
NDC 63323-0664-16 contains 25 vials — 25 vial in 1 tray / 1 ml in 1 vial.
What is the difference between NDC 63323-0664-16 and NDC 63323-0664-01?
Both are Diphenhydramine 50 mg/mL Injection, Solution — the drug itself is identical. NDC 63323-0664-16 is the 25 vials package, while NDC 63323-0664-01 is the 25 vials package.
What NDC number is used to bill for this package of Diphenhydramine 50 mg/mL Injection, Solution?
Bill NDC 63323-0664-16 — the 11-digit billing format is 63323066416. 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.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE: Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in 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.

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 127 words ▾

DOSAGE AND ADMINISTRATION: THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride in the injectable form is indicated when the oral form is impractical. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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 hr or 150 mg/m 2 /24 hr. 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 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.

⛔ Contraindications 173 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.

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 161 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 hydrochloride. 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.

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 129 words ▾

ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The most frequent adverse reactions are underscored. 1.

General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat. 2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles.

3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. 4.

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. 5. GI System: Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation.

6. GU System: Urinary frequency, difficult urination, urinary retention, early menses. 7.

Respiratory System: Thickening of bronchial secretions , tightness of chest or throat and wheezing, nasal stuffiness.

🆘 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 hydrochloride 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 is not available.

📦 How Supplied / Storage and Handling 121 words ▾

HOW SUPPLIED: DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as: Product Code Unit of Sale Strength Each RF660401 NDC 65219-820-01 Unit of 25 50 mg per mL 1 mL fill in a 2 mL vial. NDC 65219-820-00 1 mL Single Dose Vial This Product Contains an RFID. 660401 NDC 63323-664-01 Unit of 25 50 mg per mL 1 mL fill in a 2 mL vial.

NDC 63323-664-00 1 mL Single Dose Vial It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution. The container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light. Keep from freezing.

📋 Description 80 words ▾

DESCRIPTION: Diphenhydramine hydrochloride is an antihistamine drug having the chemical name 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. It occurs as a white, crystalline powder, is freely soluble in water and alcohol. The structural formula is as follows: C 17 H 21 NO•HCl M.W.

291.82 Diphenhydramine hydrochloride in the parenteral form is a sterile, pyrogen-free solution available in a concentration of 50 mg of diphenhydramine hydrochloride per mL. pH 4.0 to 6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. Structural Formula

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