Ketorolac Tromethamine


Direct Rx
Human Prescription Drug
NDC 72189-335
Ketorolac Tromethamine is a human prescription drug labeled by 'Direct Rx'. National Drug Code (NDC) number for Ketorolac Tromethamine is 72189-335. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Ketorolac Tromethamine drug includes Ketorolac Tromethamine - 5 mg/mL . The currest status of Ketorolac Tromethamine drug is Active.

Drug Information:

Drug NDC: 72189-335
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: Ketorolac Tromethamine
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: Ketorolac Tromethamine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Direct Rx
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:KETOROLAC TROMETHAMINE - 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: 07 Mar, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jun, 2026
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: ANDA203410
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:Direct Rx
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:860107
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:4EVE5946BQ
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:Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitor [EPC]
Cyclooxygenase Inhibitors [MoA]
Nonsteroidal Anti-inflammatory Drug [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
72189-335-055 mL in 1 BOTTLE (72189-335-05)07 Mar, 2022N/ANo
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:

Ketorolac tromethamine ketorolac tromethamine sodium chloride water benzalkonium chloride sodium hydroxide ketorolac tromethamine ketorolac octoxynol-40 hydrochloric acid edetate disodium

Indications and Usage:

Before you use ketorolac tromethamine ophthalmic solution 0.5% for the first time: 1.check to make sure that the tamper evident ring between the bottle and the cap is not broken ( see figure a). if the tamper evident ring is broken or missing, contact your pharmacist. [img-fig-a] 2.tear off the tamper evident ring ( see figure b). [img-fig-b] 3.to open the bottle, remove the cap by turning it in the counterclockwise direction ( see figure c). [img-fig-c] this instructions for use has been approved by the u.s. food and drug administration. rev.10/2021

Ketorolac tromethamine ophthalmic solution 0.5% is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ketorolac tromethamine ophthalmic solution 0.5% is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Description:

Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-­pyrrole group of nonsteroidal anti-inflammatory drugs (nsaids) for ophthalmic use. its chemical name is (±)-5-benzoyl-2,3-dihydro-1h pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure: ketorolac tromethamine ophthalmic solution 0.5% is supplied as a sterile isotonic aqueous 0.5% solution, with a ph of 7.4. ketorolac tromethamine ophthalmic solution 0.5% is a racemic mixture of r-(+) and s-(-)- ketorolac tromethamine. ketorolac tromethamine may exist in three crystal forms. all forms are equally soluble in water. the pka of ketorolac is 3.5. this white to off-white crystalline substance discolors on prolonged exposure to light. the molecular weight of ketorolac tromethamine is 376.41. the osmolality of ketorolac tromethamine ophthalmic solution 0.5% is 290 mosmol/kg. each ml of ketorolac tromethamine ophthalmic solution contains: active: ketorolac tromethamine 0.5%. preservative: benzalkonium chloride 0.01%. inactives: edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the ph.

Clinical Studies:

Two controlled clinical studies showed that ketorolac tromethamine ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis. two controlled clinical studies showed that patients treated for two weeks with ketorolac tromethamine ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle. results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

How Supplied:

Ketorolac tromethamine ophthalmic solution 0.5% is supplied sterile, in white opaque ldpe bottles with white opaque ldpe nozzles with hdpe grey caps as follows. 3 ml in 5 ml bottle ndc 42571-137-31 5 ml in 5 ml bottle ndc 42571-137-25 10 ml in 10 ml bottle ndc 42571-137-26 storage: store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature].

Package Label Principal Display Panel:

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