Atropine Sulfate 0.4 mg/mL Injection
Other active recalls for Atropine Sulfate (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Atropine works by blocking certain nerve signals that control things like your heart rate, gland secretions, and muscle activity. Depending on your situation, it might be used to s...
- Why is atropine being given to me — what does it actually do?
- Common effects you might notice include a dry mouth, blurred vision, light sensitivity, a faster heartbeat, flushing or warm skin, and some difficulty urinating. These are expected...
- What side effects should I expect, and which ones should make me call for help?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Atropine Sulfate — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/mL 51662-1311-01 | HF | 20 ml | — | — | 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 | — |
| Atropine Sulfate 0.4 mg/mLthis 00641-6006-10 | Hikma | 10 vials | — | — | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00641-6006-10 You're viewing this | 10 VIAL in 1 CARTON (0641-6006-10) / 20 mL in 1 VIAL (0641-6006-01) | 1971-01-01 | Inactivated by FDA |
🧭 About this NDC listing & data coverage
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 | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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. |
Questions about this listing
Is this NDC FDA-approved?
Why is there no price listed?
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND 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 ▾
DOSAGE AND 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 Atropine Sulfate Solution (mL required) mg required 1 mg per mL 0.4 mg per mL 1 1 0.80 0.80 0.60 0.60 0.50 0.50 0.40 0.40 1 0.30 0.30 0.75 0.25 0.25 0.63 0.20 0.20 0.50 0.18 0.18 0.45 0.15 0.15 0.38 0.12 0.12 0.30 0.10 0.10
0.25These 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.
⛔ Contraindications ▾
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 ▾
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 ▾
ADVERSE REACTIONS Individual tolerance varies greatly, but these systemic doses are likely to produce the following effects: 0.5 mg - Slight dryness of nose and mouth, bradycardia. 1 mg - Greater dryness of nose and mouth, with thirst; slowing, then acceleration of heart; slight mydriasis. 2 mg - Very dry mouth, tachycardia, with palpitation, mydriasis, slight blurring of near vision.
5 mg - Increase in the above symptoms plus disturbance of speech, difficulty in swallowing, headache, hot, dry skin, restlessness with asthenia. 10 mg and over - Above symptoms to extreme degree, plus ataxia, excitement, disorentation, hallucinations, delirium and coma. 65 mg - May be fatal.
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.
🔄 Drug Interactions ▾
Drug Interactions Atropine, by slowing gastric emptying and gastrointestinal mobility, may interfere with the absorption of other medications. The effect of atropine on dryness of the mouth may be increased if it is given with other drugs that have anticholinergic action.
🆘 Overdosage ▾
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 ▾
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 ▾
HOW SUPPLIED 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° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. 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: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised May 2020 462-416-02
📋 Description ▾
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 (C 17 H 23 NO 3 ) 2 •H 2 SO 4 •H 2 O. The structural formula is: structural formula
💬 Information for Patients ▾
Information for Patients Atropine causes dryness of the mouth, and when used with other drugs that can cause dryness of the mouth, the effect is additive. Patients receiving chronic treatment can develop blurred vision, and they should not be involved in activities that require good and clear vision.