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ATROPINE SULFATE .4 mg/mL Injection, 25 pouches

by HF Acquisition Co LLC, DBA HealthFirst · 25 POUCH in 1 CASE (51662-1311-3) / 1 mL in 1 POUCH (51662-1311-2)
NDC 51662-1311-03
🏷️ FDA NDC (as labeled) 51662-1311-3 billing pads the package segment with a zero
This package
Contains25 pouches Pack sizes2 compare ↓
Also comes in: 20 ml 51662-1311-01
Rx only 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

⚠️
Other active recalls for Atropine Sulfate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0795-2026
Class I · Dec 21, 2023 — Presence of Particulate Matter; identified as glass (Pfizer Inc.) · FDA recall D-0235-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51662-1311-3
Product NDC 51662-1311
11-digit billing NDC 51662131103
RxCUI 1190776
UNII 03J5ZE7KA5
SPL Set ID 77935b57-fcf6-c88a-e053-2a91aa0a0a80
Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-10-06
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION
Substance ATROPINE SULFATE
Why two NDCs? The FDA registers this code as 51662-1311-3 — 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 → 51662-1311-03. 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 Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes
How it works Cholinergic Muscarinic Antagonists, Cholinergic 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

LabelerHF Acquisition Co LLC, DBA HealthFirst
Labeler code51662
First marketedOct 2018
Product typeHuman Prescription Drug
Portfolio333 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

📗 Our plain-language guide HelloPharmacist
  • Atropine works by blocking a nerve signal that, when overactive, can cause a dangerously slow heart rate, flooding secretions, or — in poisoning — life-threatening over-stimulation...
  • Why am I being given atropine — what does it actually do?
  • It's very common to notice a dry mouth, blurred vision, light sensitivity, a faster heartbeat, flushing, or difficulty urinating — those are expected effects of how atropine works...
  • What side effects should I expect, and which ones mean I need to call for help?
📖 Read our full Atropine guide →
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.

  • 9 mg / 1 mL 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.
  • 9 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII O40UQP6WCF
    A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
  • 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.

4 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 ml
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atropine Sulfate .4 mg/mL 00404-9804-20 Henry 1 vial — AP FDA listed —
Atropine Sulfate .4 mg/mL 00641-6251-10 Hikma 10 vials — AP FDA listed —
Atropine Sulfate .4 mg/mL 16729-0512-43 Accord 1 vial — AP FDA listed —
Atropine Sulfate .4 mg/mLthis 51662-1311-03 HF 25 pouches — — FDA listed —
Atropine Sulfate .4 mg/mL 51662-1619-01 HF 20 ml — AP FDA listed —
Atropine Sulfate .4 mg/mL 63323-0580-20 Fresenius 10 vials — AP FDA listed —
Atropine Sulfate .4 mg/mL 70069-0481-10 Somerset 10 vials — AP FDA listed —
Atropine Sulfate .4 mg/mL 70518-4188-00 REMEDYREPACK 10 vials — AP FDA listed —
Atropine Sulfate .4 mg/mL 70518-4329-00 REMEDYREPACK 10 vials — AP FDA listed —
Atropine Sulfate .4 mg/mL 71872-7037-01 Medical 1 vial — — FDA listed —
Atropine Sulfate .4 mg/mL 71872-7316-01 Medical 1 vial — AP FDA listed —
Atropine Sulfate .4 mg/mL 71872-7355-01 Medical 1 vial — AP FDA listed —
Atropine Sulfate .4 mg/mL 84549-0580-20 ProPharma 20 ml — AP FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2018
On the market since
Oct 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Atropine Sulfate — the program that covers self-administered drugs. 7 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 Atropine Sulfate. 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
$2.44M
Claims incl. refills
57.2K
Beneficiaries
42.2K
Spend / beneficiary
$57.89
Spend / claim
$42.70
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 Atropine Sulfate — the ingredient across all brands.

Top reported reactions

Diarrhoea3,500
Nausea2,326
Fatigue2,111
Death1,470
Vomiting1,432
Pain1,348
Dyspnoea1,214

Age at onset

Neonate56
Infant89
Child77
Adolescent49
Adult1,559
Elderly1,378

Reporter sex

26,510 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization10,628
Death3,747
Life-threatening1,841
Disabling545
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2,233 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
51662-1311-01 20 mL in 1 VIAL, MULTI-DOSE (51662-1311-1) 2018-10-06 Active
51662-1311-03 You're viewing this 25 POUCH in 1 CASE (51662-1311-3) / 1 mL in 1 POUCH (51662-1311-2) 2020-09-04 Active

Pack size FAQ

What quantity is in NDC 51662-1311-03?
NDC 51662-1311-03 contains 25 pouches — 25 pouch in 1 case / 1 ml in 1 pouch.
What is the difference between NDC 51662-1311-03 and NDC 51662-1311-01?
Both are ATROPINE SULFATE .4 mg/mL Injection — the drug itself is identical. NDC 51662-1311-03 is the 25 pouches package, while NDC 51662-1311-01 is the 20 ml package.
What NDC number is used to bill for this package of ATROPINE SULFATE .4 mg/mL Injection?
Bill NDC 51662-1311-03 — the 11-digit billing format is 51662131103. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 — Not published for this NDC No photo available yet for this listing.
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 51662-1311-3, 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: 51662-1311-03, written without dashes as 51662131103. 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 51662-1311-03, the first segment (51662) is the labeler code FDA assigned to HF Acquisition Co LLC, DBA HealthFirst; the middle segment (1311) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 ml (51662-1311-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 109 words ▾

INDICATIONS & USAGE Atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. It is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine sulfate given with morphine may be indicated.

Atropine sulfate is indicated for relaxation of the upper gastrointestinal tract and colon during hypotonic radiography. Atropine is used as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of aminata and in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare “nerve gases”. Large doses relieve the muscarine-like symptoms and some of the central nervous system manifestations.

⏱️ Dosage and Administration 209 words ▾

DOSAGE & ADMINISTRATION The usual dose of atropine sulfate is 0.4 to 0.6 mg. Suggested dosages for pediatric patients are as follows: 7 - 16 lbs. – 0.1 mg 40 - 65 lbs. – 0.3 mg 17 - 24 lbs. – 0.15 mg 65 - 90 lbs. – 0.4 mg 24 - 40 lbs. – 0.2 mg Over 90 lbs. – 0.4 to 0.6 mg Table of Dosage Equivalents These doses may be exceeded in certain cases. For hypotonic radiography of the gastrointestinal tract, the usual adult dose is 1 mg intramuscularly.

Adults suspected of contact with organic phosporous insecticides of the parathion type should be given atropine sulfate 0.8 mg intramuscularly. If an atropine effect is not apparent within 30 minutes or if definite symptoms of the poisoning occur (nausea, vomiting, diarrhea, pupillary constriction, pulmonary edema, fasciculations of eyelids and tongue, jerky ocular movements and excessive sweating, salivation and bronchial secretion), atropine sulfate 2 mg should be given intramuscularly at hourly intervals until signs of atropinization are observed.

Up to 2 or 3 times of this dose (4 to 6 mg) may be required in severe cases. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DOSAGE

⛔ Contraindications 54 words ▾

CONTRAINDICATIONS Conditions at which inhibition of postganglionic cholinergic nerves are undesirable, such as glaucoma and tachycardia. Also contraindicated in asthma, because the parenteral dose which might relieve asthma would have an excessive drying effect upon mucous plugs in the bronchi. Prostatic hypertrophy, while not a contraindication, requires special attention to signs of urinary retention.

⚠️ Warnings 109 words ▾

WARNINGS Atropine is a highly potent drug and due care is essential to avoid overdosage, especially with intravenous administration. Pediatric populations are more susceptible than adults to the toxic effects of anticholinergic agents. Atropine I.V. decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.

Atropine is not removed by dialysis. This drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children. This product contains Benzyl Alcohol which has been associated with a fatal gasping syndrome in infants and neonates.

🤒 Adverse Reactions 52 words ▾

ADVERSE REACTIONS Individual tolerance varies greatly, but these systemic doses are likely to produce the following effects: A scarlatiniform rash may occur. Atropine may produce fever, particularly in children, through inhibition of heat loss by evaporation. Although large doses of atropine may cause an alarming condition, recovery is usual. ADVERSE EVENT TABEL

🆘 Overdosage 159 words ▾

OVERDOSAGE Toxic doses from atropine are not uncommon, especially in children. Symptoms The principle manifestations of poisoning with atropine are delirium, tachycardia and fever. Treatment In the treatment of atropine poisoning, respiratory assistance and symptomatic support are indicated.

Physostigmine salicylate, 1 to 5 mL of a dilution containing 1 mg per 5 mL of saline, should be administered intravenously. Administer the smaller dose in children and administer in not less than 2 minutes. Monitor with ECG.

Medication can be repeated every 5 minutes for a total dose of 2 mg in children and every 30 minutes for a total dose of 6 mg in adults. The fatal dose of atropine in children may be as low as 10 mg. In an adult, recovery after 1,000 mg of atropine sulfate has been reported.

Death is usually due to paralysis of the medullary centers. The fatality rate is less than 1%. If the patient survives 24 hours, they will probably recover.

🧬 Clinical Pharmacology 160 words ▾

CLINICAL PHARMACOLOGY The most important therapeutic action of atropine is the inhibition of smooth muscle and glands innervated by postganglionic cholinergic nerves. It also has central nervous system activity, which may be stimulating or depressing depending upon the dose. Following the administration of usual clinical doses, atropine produces stimulation of the medulla and higher cerebral centers.

This effect is manifested by mild central vagal excitation and moderate respiratory stimulation. Atropine sulfate also acts peripherally as a competitive antagonist of the muscarinic actions of acetylcholine. It does not prevent the release of acetylcholine but antagonizes the effect of acetylcholine on the effector cells.

These actions include vasodilation, drying of the mouth, an increase in the pulse rate, inhibition of contractions of the gastrointestinal tract, ureter, and bladder, and reduction of salivary, bronchial, gastric and sweat gland secretions. Following clinical and larger doses, atropine sulfate causes dilation of the pupils and paralysis of accommodation and, in narrow-angle glaucoma, can increase intraocular pressure.

📦 How Supplied / Storage and Handling 151 words ▾

HOW SUPPLIED ATROPINE SULFATE INJECTION, USP is supplied in the following dosage forms: NDC 51662-1311-1 ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL NDC 51662-1311-2 - 1 Pouch of ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL NDC 51662-1311-3 - Case of 25 pouches of ATROPINE SULFATE INJECTION, USP 8mg/20mL (0.4mg/mL) 20mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Atropine Sulfate Injection, USP is available in the following: 0.4 mg/mL 20 mL multiple dose vial packaged in 10s (NDC 0641-6006-10) Use only if solution is clear and seal intact.

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Manufactured by: WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Revised June 2011 462-416-01 LOGO

📋 Description 107 words ▾

DESCRIPTION Atropine Sulfate Injection, USP is a sterile solution of atropine sulfate in Water for Injection. Each mL contains Atropine Sulfate 0.4 mg; Sodium Chloride 9 mg; Benzyl Alcohol 9 mg; Water for Injection qs; pH may be adjusted with Sulfuric Acid if necessary. pH 3.0-6.5. Atropine Sulfate Injection, USP may be given intramuscularly, intravenously or subcutaneously.

Atropine is a white crystalline alkaloid which may be extracted from belladonna root or may be produced synthetically. It is used as atropine sulfate because this compound has much greater solubility. Atropine sulfate is an anticholinergic drug.

The empirical formula of atropine sulfate is (C17H23NO3)2•H2SO4•H2O. The structural formula is: STRUCTURE

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51662-1310-01 · HF 51662-1312-01 · HF →
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.