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Diphenhydramine Hydrochloride 50 mg/mL Injection, Solution, 25 vials — NDC 25021-0481-01 package photo

Diphenhydramine Hydrochloride 50 mg/mL Injection, Solution, 25 vials

by Sagent Pharmaceuticals · 25 VIAL in 1 CARTON (25021-481-01) / 1 mL in 1 VIAL
NDC 25021-0481-01
🏷️ FDA NDC (as labeled) 25021-481-01 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) 25021-481-01
Product NDC 25021-481
11-digit billing NDC 25021048101
NCPDP billing unit ML — per mL (volume)
RxCUI 1723740
UNII TC2D6JAD40
Application # ANDA218448
SPL Set ID 6533e629-a27b-4489-8fa3-7de32fbf809e
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 2025-01-15
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 25021-481-01 — 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 → 25021-0481-01. 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

LabelerSagent Pharmaceuticals
Application holderGLAND PHARMA LTD
FDA applicationANDA218448 (ANDA)
Labeler code25021
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio209 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 $41.87 $1,046.84 / 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
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.946 $0.934
▼ Down 1% over the last 9 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)25021-481-01
11-digit billing NDC25021-0481-01
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/mLthis 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/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

🏛️
2025
On the market since
Jan 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.

🗺️ 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 25021-0481-01, 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 – Q1 2026 · 5 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
14.5K
Units reimbursed last 4 qtrs
19.4K
Gross reimbursed last 4 qtrs
$813.3K
Avg / prescription
$56.14
Avg / unit
$41.8743
Latest quarter Q1 2026
5.2KRx
Medicaid pays / mL
$41.8743
gross reimbursed
vs
NADAC / mL
$0.9336
acquisition cost
=
Spread
+$40.9407
+4385% 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 ⓘ
16% FFS 84% MCO
Fee-for-service · 2,259 Rx Managed care · 12,228 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 16 units · 0.2 per 100k residents WA Idaho: 763 units · 38.8 per 100k residents ID Montana: no data reported MT North Dakota: 326 units · 41.6 per 100k residents ND Minnesota: 355 units · 6.2 per 100k residents MN Wisconsin: 181 units · 3.1 per 100k residents WI Michigan: no data reported MI New York: 937 units · 4.8 per 100k residents NY Vermont: no data reported VT New Hampshire: 109 units · 7.8 per 100k residents NH Oregon: 142 units · 3.4 per 100k residents OR Nevada: 73 units · 2.3 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 296 units · 9.2 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 1,793 units · 15.2 per 100k residents OH Pennsylvania: 1,426 units · 11.0 per 100k residents PA New Jersey: 105 units · 1.1 per 100k residents NJ Massachusetts: 579 units · 8.3 per 100k residents MA California: 3,015 units · 7.7 per 100k residents CA Utah: no data reported UT Colorado: 1,294 units · 22.0 per 100k residents CO Nebraska: 497 units · 25.1 per 100k residents NE Missouri: 151 units · 2.4 per 100k residents MO Kentucky: 570 units · 12.6 per 100k residents KY West Virginia: 15 units · 0.8 per 100k residents WV Virginia: 224 units · 2.6 per 100k residents VA Maryland: 10 units · 0.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 160 units · 7.6 per 100k residents NM Kansas: 236 units · 8.0 per 100k residents KS Arkansas: no data reported AR Tennessee: 166 units · 2.3 per 100k residents TN North Carolina: 2,094 units · 19.3 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 117 units · 2.9 per 100k residents OK Louisiana: 638 units · 13.9 per 100k residents LA Mississippi: 194 units · 6.6 per 100k residents MS Alabama: 278 units · 5.4 per 100k residents AL Georgia: 36 units · 0.3 per 100k residents GA D.C.: 156 units · 23.0 per 100k residents DC Hawaii: no data reported HI Texas: 812 units · 2.7 per 100k residents TX Florida: 1,488 units · 6.6 per 100k residents FL
Units reimbursed · per 100k residents
0.241.6
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 North Dakota 41.6 /100k
2 Idaho 38.8 /100k
3 Nebraska 25.1 /100k
4 D.C. 23.0 /100k
5 Colorado 22.0 /100k
6 North Carolina 19.3 /100k
7 Ohio 15.2 /100k
8 Louisiana 13.9 /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.

🔬 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 HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Fatigue16,399
Nausea14,606
Headache14,003
Pain11,969
Dyspnoea11,085
Pruritus10,525
Infusion Related Reaction9,947

Age at onset

Neonate106
Infant195
Child1,828
Adolescent1,476
Adult20,867
Elderly9,044

Reporter sex

171,992 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization49,087
Life-threatening7,190
Disabling3,673
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,771 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
25021-0481-01 You're viewing this 25 VIAL in 1 CARTON (25021-481-01) / 1 mL in 1 VIAL 2025-01-15 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 129 words ▾

INDICATIONS AND USAGE Diphenhydramine Hydrochloride Injection 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 124 words ▾

DOSAGE AND ADMINISTRATION THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine Hydrochloride Injection 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 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 119 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 Sagent Pharmaceuticals at 1-866-625-1618 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 80 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 is not available.

📦 How Supplied / Storage and Handling 104 words ▾

HOW SUPPLIED DiphenhydrAMINE Hydrochloride Injection, USP is supplied as follows: NDC DiphenhydrAMINE Hydrochloride Injection, USP (50 mg per mL) Package Factor 25021-481-01 50 mg per 1 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. Retain in carton until time of use. Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2024 Sagent Pharmaceuticals May 2024 SAGENT Pharmaceuticals ®

📦 Storage and Handling 71 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. Retain in carton until time of use. Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2024 Sagent Pharmaceuticals May 2024 SAGENT Pharmaceuticals ®

📋 Description 88 words ▾

DESCRIPTION Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride USP 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 • HCI 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 ↗
← 25021-0477-01 · Sagent 25021-0500-02 · Sagent →
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.