Proparacaine Hydrochloride
Sandoz Inc.
Human Prescription Drug
NDC 61314-016Proparacaine Hydrochloride is a human prescription drug labeled by 'Sandoz Inc.'. National Drug Code (NDC) number for Proparacaine Hydrochloride is 61314-016. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Proparacaine Hydrochloride drug includes Proparacaine Hydrochloride - 5 mg/mL . The currest status of Proparacaine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 61314-016 |
| 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: | Proparacaine Hydrochloride |
| 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: | Proparacaine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sandoz Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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: | PROPARACAINE HYDROCHLORIDE - 5 mg/mL
|
| 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: | ANDA |
| 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: | 05 Jun, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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. |
| Application Number: | ANDA080027 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Sandoz Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1191013
|
| 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. |
| UPC: | 0361314016010
|
| UPC stands for Universal Product Code. |
| UNII: | U96OL57GOY
|
| 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: | Local Anesthesia [PE]
Local Anesthetic [EPC]
|
| 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 |
|---|
| 61314-016-01 | 1 BOTTLE in 1 CARTON (61314-016-01) / 15 mL in 1 BOTTLE | 05 Jun, 2000 | 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:
Proparacaine hydrochloride proparacaine hydrochloride proparacaine hydrochloride proparacaine benzalkonium chloride glycerin water hydrochloric acid sodium hydroxide label carton
Indications and Usage:
Indications and usage proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.
Warnings:
Warnings not for injection - for topical ophthalmic use only. prolonged use of a topical ocular anesthetic is not recommended. it may produce permanent corneal opacification with accompanying visual loss.
Dosage and Administration:
Dosage and administration usual dosage: removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating. short corneal and conjunctival procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses. note: proparacaine hydrochloride ophthalmic solution should be clear to straw-color. if the solution becomes darker, discard the solution.
Contraindications:
Contraindications proparacaine hydrochloride ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.
Adverse Reactions:
Adverse reactions occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. a rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported. allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has also been reported.
Use in Pregnancy:
Pregnancy pregnancy category c: animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution 0.5%. it is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.
Geriatric Use:
Geriatric use no overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients
Description:
Description proparacaine hydrochloride ophthalmic solution 0.5% is a topical local anesthetic for ophthalmic use. the active ingredient is represented by the structural formula: established name: proparacaine hydrochloride chemical name: benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride. molecular weight: 330.85 each ml contains: active: proparacaine hydrochloride 5mg 0.5%. preservative: benzalkonium chloride (0.01%). inactives: glycerin; and purified water. the ph may be adjusted with hydrochloric acid and/or sodium hydroxide. chemical
Clinical Pharmacology:
Clinical pharmacology proparacaine hydrochloride ophthalmic solution is a rapidly-acting topical anesthetic, with induced anesthesia lasting approximately 10-20 minutes.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility in males or females.
How Supplied:
How supplied proparacaine hydrochloride ophthalmic solution 0.5% is supplied in 15 ml drop-tainer* dispensers. ndc 61314-016-01 storage: bottle must be stored in unit carton to protect contents from light. store bottles under refrigeration at 2° - 8°c (36° - 46°f). rx only
Package Label Principal Display Panel:
Principal display panel ndc 61314-016-01 proparacaine hydrochloride ophthalmic solution, usp 0.5% rx only sterile 15 ml precaution: not for injection. for topical ophthalmic use only. do not touch dropper tip to any surface, as this may contaminate the solution. usual dosage: 1 or 2 drops. read enclosed insert. storage: store between 2° to 8°c (36° to 46°f). proparacaine hydrochloride ophthalmic solution should be clear to straw-color. if the solution becomes darker, discard the solution. bottles must be stored in unit carbon to protect from light. ingredients: each ml contains: active: proparacaine hydrochloride 5 mg (0.5%). preservative: benzalkonium chloride 0.01%. inactives: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust ph), purified water. manufactured by alcon laboratories, inc. manufactured by alcon laboratories, inc. fort worth, texas 76134 for sandoz inc., princeton, nj 08540 product of switzerland 9014663-1017 rev.10/2017 ndc 61314-016-01 proparacaine hydrochloride ophthalmic solution, usp 0.5% rx only sterile 15 ml sandoz ingredients: each ml contains: active: proparacaine hydrochloride 5 mg (0.5%). precaution: not for injection. for topical ophthalmic use only. do not touch dropper tip to any surface as this may contaminate the solution. usual dosage: 1 or 2 drops. read enclosed insert. storage: store between 2º-8ºc (36º-46ºf). bottles must be stored in unit carton to protect from light. proparacaine hydrochloride ophthalmic solution should be clear to straw-color. if the solution becomes darker, discard the solution. manufactured by alcon laboratories, inc. fort worth, texas 76134 for sandoz inc. princeton, nj 08540 rev. 04-2012 lot/exp.: h14233-0216