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ANTICHOLIUM physostigmine salicylate .4 mg/mL Injection — NDC 81284-0831-05 package photo

ANTICHOLIUM physostigmine salicylate .4 mg/mL Injection

by Provepharm Inc. · 5 AMPULE in 1 CARTON (81284-831-05) / 5 mL in 1 AMPULE
NDC 81284-0831-05
🏷️ FDA NDC (as labeled) 81284-831-05 billing pads the product segment with a zero
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

🆔 Identity & classification

FDA NDC (as labeled) 81284-831-05
Product NDC 81284-831
11-digit billing NDC 81284083105
NCPDP billing unit ML — per mL (volume)
RxCUI 2666367, 2666374
UNII 2046ZRO9VU
SPL Set ID b90b50e8-c8f1-4f2d-be6e-4d269b8c362c
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-05
Route INTRAVENOUS
Dosage form INJECTION
Substance PHYSOSTIGMINE SALICYLATE
GCN Seq No 028623
GCN 00459
HICL code 001985
Ingredient (HICL) Physostigmine Salicylate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J1
Therapeutic class — intermediate (HIC2) Cholinergics
HIC3 code J1B
Therapeutic class — specific (HIC3) Cholinesterase Inhibitors
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name ANTICHOLIUM 2 MG/5 ML AMPULE
FDB brand name Anticholium
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 81284-831-05 — 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 → 81284-0831-05. 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 Parasympathomimetics class.

Drug family (ATC) Parasympathomimetics, Antidotes
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

LabelerProvepharm Inc.
Labeler code81284
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio13 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 ANTICHOLIUM 2 MG/5 ML AMPULE Ingredient Physostigmine Salicylate
🧪 What is this product?

This is an intravenous injection containing physostigmine salicylate, a cholinesterase inhibitor. Physostigmine is typically used to reverse the effects of certain anticholinergic substances and medications by increasing levels of the neurotransmitter acetylcholine in the body. This product is marketed without an approved FDA application and is available for use during drug shortages.

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 MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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.

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.
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
Anticholium .4 mg/mLthis 81284-0831-05 Provepharm 5 ampules — — 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

🔬 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 ANTICHOLIUM (this brand).

Top reported reactions

Anticholinergic Syndrome2
Neuromuscular Block Prolonged2
Blood Creatine Phosphokinase Increased1
Blood Potassium Increased1
Bradycardia1
Cardiac Arrest1
Hyperthermia Malignant1

Reporter sex

0 reports

Serious outcomes

Life-threatening4
Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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
81284-0831-05 You're viewing this 5 AMPULE in 1 CARTON (81284-831-05) / 5 mL in 1 AMPULE 2023-10-05 Active

🧭 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 ✓ Available
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 For Use In Drug Shortage". 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 81284-831-05, 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: 81284-0831-05, written without dashes as 81284083105. 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 81284-0831-05, the first segment (81284) is the labeler code FDA assigned to Provepharm Inc.; the middle segment (0831) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Provepharm Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Provepharm Inc. 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🆘 Overdosage 📦 How Supplied / Storage and Handling 📦 Storage and Handling
🎯 Indications and Usage 86 words ▾

Indications: ANTICHOLIUM ® is indicated for: 1. the use as an antidote and/or antagonist in case of intoxication with and/or overdose of: alcohol tropane alkaloids (hyoscyamine, atropine, scopolamine, as e.g. in brugmansia, datura, atropa belladonna) amanita pantherina and amanita muscaria tricyclic antidepressants (amitriptyline, imipramine, trimipramine, clomipramine, doxepine) antiemetics/antihistamines (phenothiazine, thioridazine, chlorpromazine, promethazine, diphenhydramine, dimenhydrinate) neuroleptic drugs (especially butyrophenones) benzodiazepines tolterodine, oxybutynine amantadine, diphenhydramine baclofen 4-hydroxybutyric acid (GHB) inhalation anesthetics ketamine 3-quinuclidinyl benzilate 2. the treatment of postoperative disorders: Central anticholinergic syndrome (CAS) Delayed postoperative awakening Shivering

⏱️ Dosage and Administration 196 words ▾

Dosage and Administration: Use in adults: For the treatment of postoperative awakening disorders: Slowly inject physostigmine intravenously at a dose of 0.04 mg/kg bodyweight (approx. 1 mg/min), the maximum individual dose is 2 mg. In case of insufficient effect, give subsequent injections after 5 to 20 minutes at the earliest, after a positive evaluation of the effect of the first injection.

In cases of intoxication: Adults: Slowly inject 0.04 mg/kg bodyweight (2 mg) of physostigmine salicylate intravenously and subsequently inject 1-4 mg every 20 minutes. Repeat the effective dose if the intoxication symptoms recur, also in the form of a continuous infusion if deemed useful. Use in children and adolescents: In cases of intoxication: Infants: Start with a low dose of 0.5 mg of physostigmine salicylate administered intravenously, repeat this dose every 5 minutes up to the overall dose of 2 mg, as long as the toxic, anticholinergic symptoms continue to persist, and no cholinergic symptoms occur.

Method of administration: Intravenously slowly or as brief infusion in 50 ml physiological saline solution over 10-15 minutes. A general criterion for adequate physostigmine dosing is the recognizable recovery of mental abilities and responsiveness (e.g. specifying name, address, date).

💊 Dosage Forms and Strengths 28 words ▾

Composition: Anticholium is available in 5 mL ampules, each mL containing 0.4 mg physostigmine salicylate in a vehicle composed of sodium edetate (Ph. Eur.) and water for injection.

⛔ Contraindications 95 words ▾

Contraindications: ANTICHOLIUM ® should not be used in the presence of hypersensitivity to physostigmine salicylate, bronchial asthma, ulcers associated with tissue destruction (gangrene), coronary heart disease, constipation (mechanical obstipation), mechanical ischuria (urinary retention), hereditary form of muscle atrophy (myotonic dystrophy), closed traumatic brain injuries, intestinal obstruction, spasms in the urinary tract collection system, inactivation of nerve and muscle cells after administration of drugs to relax the muscles (depolarization block after depolarizing muscle relaxants), in case of intoxication due to “irreversibly acting” cholinesterase inhibitors (drugs used to treat dementia), intoxication with phosphoric acid esters or barbiturates.

⚠️ Warnings and Cautions 106 words ▾

Precautions: Talk to your doctor before you are given ANTICHOLIUM ® if you suffer from diabetes mellitus, slowed heart rate (bradycardia), disturbances of the atrioventricular conduction system, Parkinson’s disease or ulcerative colitis. Hypersensitivity reactions may occur after administration of this medicine. These reactions may vary individually and may also cause life-threatening conditions.

It is recommended to have emergency medication and medical aids ready. A risk/benefit analysis should be performed, and discontinuation of treatment should be considered. Acute cardiac arrest may be possible during treatment with tricyclic antidepressants; therefore, Anticholium should only be considered as an antidote for this indication while the patient has continuous ECG monitoring.

🤒 Adverse Reactions 70 words ▾

Adverse Reactions: Like all medicines, ANTICHOLIUM ® can cause side effects, although not everybody gets them. System organ class Frequency: Unknown Immune system disorders Hypersensitivity reactions Endocrine disorders Hypersalivation Heart diseases Changes of the heart rate (both bradycardia and tachycardia), sinoatrial block Vascular diseases Low blood pressure (hypotension) Respiratory, thoracic and mediastinal disorders Spasms of the respiratory tract (broncho spasms) Gastrointestinal disorders Nausea, vomiting Skin and subcutaneous tissue disorders Sweating

🔄 Drug Interactions 61 words ▾

Interactions: Tell your doctor or pharmacist if you are taking/ using, have recently taken/used or intend to take/ use any other medicines. In case of simultaneous administration of other cholinesterase inhibitors (e.g. medicines for the treatment of dementia), caution should be exercised because of the potentiating effect. In intoxication with depolarizing muscle relaxants of the suxamethonium type, ANTICHOLIUM ® is contraindicated!

👥 Use in Specific Populations 128 words ▾

Usage in pregnancy: Pregnancy and breast-feeding Pregnancy: There is no experience with the use of ANTICHOLIUM ® in pregnant women. Physostigmine, the active substance contained in ANTICHOLIUM ® , passes into the placenta. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, birth and postnatal development.

The potential risk for humans is unknown. For this reason, ANTICHOLIUM ® may only be administered to pregnant women if deemed absolutely necessary by the attending doctor. Breast-feeding: There is no experience with the use of ANTICHOLIUM ® during breastfeeding.

It is not known whether physostigmine, the active substance contained in ANTICHOLIUM ® , is excreted in human breast milk. For this reason, ANTICHOLIUM ® may only be used during breastfeeding if deemed absolutely necessary by the attending doctor.

🤰 Pregnancy 70 words ▾

Pregnancy: There is no experience with the use of ANTICHOLIUM ® in pregnant women. Physostigmine, the active substance contained in ANTICHOLIUM ® , passes into the placenta. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, birth and postnatal development.

The potential risk for humans is unknown. For this reason, ANTICHOLIUM ® may only be administered to pregnant women if deemed absolutely necessary by the attending doctor.

🆘 Overdosage 102 words ▾

Overdosage: Intravenous administration of atropine up to normalization of the symptoms. Normally, half the amount of the administered physostigmine salicylate is sufficient. In case of intoxication, measures to prevent absorption are to be started immediately (such as gastric lavage, administration of medicinal charcoal and laxatives).

The following information is intended for healthcare professionals: Overdose emergency measures, symptoms, antidotes In cases of intoxication, measures to prevent absorption such as gastric lavage, administration of medicinal charcoal and laxatives are to be started immediately. An overdose of ANTICHOLIUM ® can cause bradycardia, hypersalivation, vomiting, and generalized tonic-clonic seizures. Patients should be closely monitored by ECG.

📦 How Supplied / Storage and Handling 22 words ▾

How Supplied: ANTICHOLIUM ® is a clear, colorless to slightly reddish solution in glass ampules. Pack containing 5 ampules with 5 ml.

📦 Storage and Handling 66 words ▾

Storage Conditions: Store this medicine protected from light in the outer packaging, not above 25°C. In undamaged container: 3 years The infusion solution should be used immediately after preparation. Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton/label after EXP. The expiry date refers to the last day of that month.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81284-0612-10 · Provepharm 81286-0101-10 · UNITRADE →
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.