Atropine Sulfate
Henry Schein, Inc.
Human Prescription Drug
NDC 0404-9820Atropine Sulfate is a human prescription drug labeled by 'Henry Schein, Inc.'. National Drug Code (NDC) number for Atropine Sulfate is 0404-9820. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Atropine Sulfate drug includes Atropine Sulfate - .4 mg/mL . The currest status of Atropine Sulfate drug is Active.
Drug Information:
| Drug NDC: | 0404-9820 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Atropine Sulfate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Atropine Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Henry Schein, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ATROPINE SULFATE - .4 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 09 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Aug, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 29 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Henry Schein, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1666781
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | 03J5ZE7KA5
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Anticholinergic [EPC]
Cholinergic Antagonists [MoA]
Cholinergic Muscarinic Antagonist [EPC]
Cholinergic Muscarinic Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0404-9820-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9820-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 09 Jan, 2022 | 31 Aug, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Atropine sulfate atropine sulfate atropine sulfate atropine
Indications and Usage:
Indications and usage 1. in the treatment of parkinsonism. rigidity and tremor relieved by the apparently selective depressant action. 2. in the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon. 3. to relieve hypertonicity of the uterine muscle. 4. to relax the spasm of biliary and uretered colic and bronchial spasm. 5. to diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders. 6. to control the crying and laughing episodes in patients with brain lesions. 7. in cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal eeg patterns, stupor and neurological signs. 8. in the management of peptic ulcer. 9. in anesthesia to control excessive salivation and bronchial secretions. 10. to control rhinorrhea of acute rhinitis or hay fever. 11. as an antidote for pilocarpine, physostigmine, iso
Read more...flurophate, choline esters, certain species of aminata and in cases of anticholinesterase insecticide poisoning. 12. in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare ânerve gasesâ, large doses of atropine relieve the muscarine-like symptoms and some of the central-nervous-system manifestations. adults suspected of contact with organic phosphorus insecticides of the parathion type should be given atropine sulfate, 0.8 mg, intramuscularly. if an atropine effect is not apparent within thirty 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 two or three times this dose (4 to 6 mg) may be required in severe cases. removing contaminated clothing, washing the skin, and commencing artificial respiration and supportive therapy are also indicated.
Warnings:
Warnings this drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children.
Dosage and Administration:
Dosage and administration the usual adult dose of atropine is 0.4 to 0.6 mg. suggested doses for children are as follows: 7-16 pounds 0.1 mg 17-24 pounds 0.15 mg 24-40 pounds 0.2 mg 40-65 pounds 0.3 mg 65-90 pounds 0.4 mg over 90 pounds 0.4 to 0.6 m as indicated previously, however, these doses may be considerably exceeded in certain cases. parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
Contraindications:
Contraindications conditions in 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.
Adverse Reactions:
Adverse reactions toxic effects from overdosage of atropine are not uncommon, especially in children. 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; flushed, dry skin. 5 mg ⢠increase in 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, disorientation, 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
Read more... condition, recovery is usual. in the treatment of atropine poisoning, respiratory assistance and symptomatic support are indicated. pilocarpine is sometimes given but is of limited value.
Description:
Description atropine sulfate injection, usp is a sterile, isotonic solution of atropine sulfate in water for injection q.s. sodium chloride added for isotonicity. ph adjusted with sulfuric acid. preservative free. atropine is a white crystalline alkaloid which may be extracted from belladonna root and hyoscyamine or may be produced synthetically. it is used in the form of atropine sulfate because this compound has much greater solubility in water. the structural formula of atropine is as follows: molecular formula molecular weight c17h23no3 289.37 formula
Clinical Pharmacology:
Clinical pharmacology atropine has two actions. the most important therapeutic action is the inhibition of smooth muscle and glands innervated by postganglionic cholinergic nerves. atropine also has central-nervous system activity, which may be stimulating or depressing depending upon the dose.
How Supplied:
How supplied product no. concentration vial/ampule size ndc 0517-0805-25 0.4 mg/0.5 ml 0.5 ml ampule packed in boxes of 25 ndc 0517-0101-25 1.0 mg/1 ml 1 ml ampule packed in boxes of 25 ndc 0517-0401-25 0.4 mg/1 ml 1 ml single dose vial packed in boxes of 25 ndc 0517-1010-25 1.0 mg/1 ml 1 ml single dose vial packed in boxes of 25 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). in1010 rev. 1/09 mg #7603 american regent, inc. shirley, ny 11967
Package Label Principal Display Panel:
Sample package label label1.jpg