Olopatadine Hydrochloride Ophthalmic Solution
Olopatadine Hydrochloride Ophthalmic
Rugby Laboratories
Human Otc Drug
NDC 0536-1307Olopatadine Hydrochloride Ophthalmic Solution also known as Olopatadine Hydrochloride Ophthalmic is a human otc drug labeled by 'Rugby Laboratories'. National Drug Code (NDC) number for Olopatadine Hydrochloride Ophthalmic Solution is 0536-1307. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Olopatadine Hydrochloride Ophthalmic Solution drug includes Olopatadine Hydrochloride - 2 mg/mL . The currest status of Olopatadine Hydrochloride Ophthalmic Solution drug is Active.
Drug Information:
| Drug NDC: | 0536-1307 |
| 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: | Olopatadine Hydrochloride Ophthalmic Solution |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Olopatadine Hydrochloride Ophthalmic |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rugby Laboratories |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | 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: | OLOPATADINE HYDROCHLORIDE - 2 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: | 15 Jan, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 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: | ANDA209752 |
| 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: | Rugby Laboratories
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1111343
|
| 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: | 2XG66W44KF
|
| 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: | Decreased Histamine Release [PE]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Inhibitor [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 |
|---|
| 0536-1307-23 | 1 BOTTLE, PLASTIC in 1 CARTON (0536-1307-23) / 2.5 mL in 1 BOTTLE, PLASTIC | 15 Jan, 2021 | 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. |
Purpose:
Purpose antihistamine
Product Elements:
Olopatadine hydrochloride ophthalmic solution olopatadine hydrochloride ophthalmic olopatadine hydrochloride olopatadine benzalkonium chloride sodium phosphate, dibasic, anhydrous edetate disodium hydrochloric acid povidone k30 sodium chloride sodium hydroxide water carton
Indications and Usage:
Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
Warnings:
Warnings for external use only
Do Not Use:
Warnings for external use only
When Using:
When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use do not wear a contact lens if your eye is red
Dosage and Administration:
Directions adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily, no more than once per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use children under 2 years of age: consult a doctor
Stop Use:
Stop use and ask doctor if you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours
Package Label Principal Display Panel:
Principal display panel olopatadine hydrochloride ophthalmic solution, usp 0.2%