Atropine Sulfate
Bausch & Lomb Incorporated
Human Prescription Drug
NDC 24208-825Atropine Sulfate is a human prescription drug labeled by 'Bausch & Lomb Incorporated'. National Drug Code (NDC) number for Atropine Sulfate is 24208-825. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Atropine Sulfate drug includes Atropine Sulfate - 10 mg/g . The currest status of Atropine Sulfate drug is Active.
Drug Information:
| Drug NDC: | 24208-825 |
| 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: | Bausch & Lomb Incorporated |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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 - 10 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| 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: | 30 Sep, 1990 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| 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: | 31 Dec, 2023 |
| 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: | Bausch & Lomb Incorporated
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1190570
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 24208-825-55 | 1 TUBE in 1 CARTON (24208-825-55) / 3.5 g in 1 TUBE | 30 Sep, 1990 | N/A | 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 lanolin oil mineral oil water petrolatum
Indications and Usage:
Indications and usage for mydriasis and/or cycloplegia. for cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.
Warnings:
Warnings in pediatric patients, use with extreme caution. excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. if this occurs, discontinue medication and use appropriate therapy as outlined in overdosage .
General Precautions:
Patient warning: patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. parents should be warned not to get this preparation in their childrenâs mouth and to wash their own hands and the childâs hands following administration.
Dosage and Administration:
Dosage and administration apply a small amount of ointment to the conjunctival sac once or twice a day, or as directed by a physician. for ophthalmic use only
Contraindications:
Contraindications this product should not be used in patients with primary glaucoma or a predisposition to narrow anterior chamber angle glaucoma. this product should not be used in pediatric patients who have previously had a severe systemic reaction to atropine. this product should not be used in those persons showing hypersensitivity to any component of this preparation.
Adverse Reactions:
Adverse reactions prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. severe reactions are manifested by hypotension with progressive respiratory depression. coma and death have been reported in the very young. to report suspected adverse reactions, contact bausch & lomb incorporated at 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Pediatric Use:
Pediatric use: see contraindications and warnings .
Overdosage:
Overdosage systemic atropine toxicity is manifested by flushing and dryness of the skin (a rash may be present in pediatric patients), blurred vision, a rapid and irregular pulse, fever, abdominal distension in infants, mental aberration (hallucinosis) and loss of neuromuscular coordination. atropine poisoning, although distressing, is rarely fatal, even with large doses of atropine, and is self-limited if the cause is recognized and the atropine medication is discontinued. in severe intoxication, physostigmine salicylate may be administered parenterally to provide more prompt relief of the intoxication. give physostigmine salicylate as 1-5 ml iv of dilution containing 1 mg in 5 ml of saline. the smaller dose is for pediatric patients, and injection should take not less than 2 minutes. ekg control is advisable. dosage can be repeated every 5 minutes up to a total dose of 2 mg in pediatric patients and 6 mg in adults every 30 minutes. physostigmine is contraindicated in hypotensive reactions. atropine (1 mg) should be available for immediate injection if physostigmine causes bradycardia, convulsions or bronchoconstriction. in pediatric patients, the body surface must be kept moist. use extreme caution when employing short-acting barbiturates to control excitement.
Description:
Description: atropine sulfate ophthalmic ointment, 1% is a sterile topical anticholinergic for ophthalmic use. the active ingredient is represented by the chemical structural formula: (c 17 h 23 no 3 ) 2 â¢h 2 so 4 â¢h 2 o mol. wt. 694.83 chemical name: benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo -(±)-, sulfate (2:1) (salt), monohydrate. each gram contains: active: atropine sulfate, 1% (10 mg); inactives: lanolin oil, mineral oil, purified water, and white petrolatum. chem_structure.jpg
Clinical Pharmacology:
Chemical pharmacology the anticholinergic effect of this product blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility: no studies have been conducted in animals or in humans to evaluate the potential of these effects. animal reproduction studies have not been performed with atropine. it is also not known whether atropine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. atropine should be given to pregnant women only if clearly needed.
How Supplied:
How supplied atropine sulfate ophthalmic ointment, 1% is supplied in an ophthalmic tip applicator tube in the following size: 3.5 g tubes - ndc 24208-825-55 image 1
Package Label Principal Display Panel:
Package/label principal display panel ndc 24208-825-55 atropine sulfate ophthalmic ointment, 1% (sterile) for ophtalmic use only rx only net. wt. 1/8 oz. (3.5g) bausch + lomb carton.jpg