NDC 53020-265 Dapiprazole

Dapiprazole

NDC Product Code 53020-265

NDC Code: 53020-265

Proprietary Name: Dapiprazole What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dapiprazole What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 53020 - Baradaina, Llc
    • 53020-265 - Dapiprazole

NDC 53020-265-01

Package Description: 1 KIT in 1 CARTON * 5 mL in 1 VIAL (53020-245-01) * 5 mL in 1 VIAL (53020-255-01)

NDC Product Information

Dapiprazole with NDC 53020-265 is a a human prescription drug product labeled by Baradaina, Llc. The generic name of Dapiprazole is dapiprazole. The product's dosage form is kit and is administered via form.

Labeler Name: Baradaina, Llc

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MANNITOL (UNII: 3OWL53L36A)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
  • WATER (UNII: 059QF0KO0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Baradaina, Llc
Labeler Code: 53020
FDA Application Number: ANDA204902 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-31-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dapiprazole Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description:

For ophthalmic use only.Dapiprazole hydrochloride is an alpha-adrenergic blocking agent.Dapiprazole hydrochloride is 5,6,7,8-tetrahydro-3-[2-(4-


o .tolyl-1-piperazinyl)ethyl]-


s -triazolo[4,3-a]pyridine hydrochloride.


Dapiprazole hydrochloride has the empirical formula C


19H


27N


5 • HCl and a molecular weight of 361.93.


The structural formula for dapiprazole hydrochloride is:Dapiprazole hydrochloride is a sterile, white, lyophilized powder soluble in water.Dapiprazole hydrochloride ophthalmic solution, 0.5% is a clear, colorless, slightly viscous solution for topical application. Each mL (when reconstituted as directed) contains 5 mg of dapiprazole hydrochloride as the active ingredient.The reconstituted solution has a pH of approximately 6.6 and an osmolarity of approximately 415 mOsm.The inactive ingredients include: mannitol (2%), sodium chloride, hydroxypropyl methylcellulose (0.4%), edetate sodium (0.01%), sodium phosphate dibasic, sodium phosphate monobasic, water for injection, and benzalkonium chloride (0.01%) as a preservative.Dapiprazole hydrochloride ophthalmic solution, 0.5% is supplied in a kit consisting of one vial of dapiprazole hydrochloride (25 mg), one vial of diluent (5 mL) and one dropper for dispensing.

Clinical Pharmacology:

Dapiprazole hydrochloride ophthalmic solution acts through blocking the alpha-adrenergic receptors in smooth muscle. Dapiprazole hydrochloride ophthalmic solution produces miosis through an effect on the dilator muscle of the iris.Dapiprazole hydrochloride ophthalmic solution does not have any significant activity on ciliary muscle contraction and, therefore does not induce a significant change in the anterior chamber depth or the thickness of the lens.Dapiprazole hydrochloride ophthalmic solution has demonstrated safe and rapid reversal of mydriasis produced by phenylephrine and to a lesser degree tropicamide. In patients with decreased accommodative amplitude due to treatment with tropicamide, dapiprazole hydrochloride ophthalmic solution partially restores the accommodative amplitude. This activity is not only due to its miotic effect but also to a direct effect on accommodation.Eye color affects the rate of pupillary constriction. In individuals with brown irides, the rate of pupillary constriction may be slightly slower than in individuals with blue or green irides. Eye color does not appear to affect the final pupil size.Dapiprazole hydrochloride ophthalmic solution does not significantly alter intraocular pressure in normotensive eyes or in eyes with elevated intraocular pressure.

Indications And Usage:

Dapiprazole hydrochloride ophthalmic solution is indicated in the treatment of iatrogenically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents. Dapiprazole hydrochloride ophthalmic solution is not indicated for the reduction of intraocular pressure or in the treatment of open angle glaucoma.

Contraindications:

Miotics are contraindicated where constriction is undesirable; such as acute iritis, and in those subjects showing hypersensitivity to any component of this preparation.

Warning:

For Topical Ophthalmic Use Only. NOT FOR INJECTION. Do not touch the dropper up to lids or any surface, as this may contaminate the solution. Dapiprazole hydrochloride ophthalmic solution should not be used in the same patient more frequently than once a week.

Information To Patients:

Miosis may cause difficulty in dark adaptation and may reduce the field of vision. Patients should exercise caution when involved in night driving or other activities in poor illumination.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

Dapiprazole has been shown to significantly increase the incidence of liver tumors in rats after continuous dietary administration for 104 weeks. This effect was found only in male rats treated with the highest dose administered in the study, i.e., 300 mg/kg/day, (80,000 times the human dose) and was not observed in male and female rats at doses of 30 and 100 mg/kg/day and female rats at doses of 300 mg/kg/day.Negative results have been reported on the mutagenicity and impairment of fertility studies with dapiprazole hydrochloride.

Pregnancy:

Reproduction studies have been performed in rats and rabbits at doses up to 128,000 (rat) and 27,000 (rabbit) times the human ophthalmic dose and revealed no evidence of impaired fertility or harm to the fetus due to dapiprazole hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dapiprazole hydrochloride ophthalmic solution is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients below the age of 4 have not been established.

Adverse Reactions:

In controlled studies the most frequent reaction to dapiprazole was conjunctival injection lasting 20 minutes in over 80% of patients. Burning on instillation of dapiprazole hydrochloride ophthalmic solution was reported in approximately half of all patients. Reactions occurring in 10% to 40% of patients included ptosis, lid erythema, lid edema, chemosis, itching, punctate keratitis, corneal edema, browache, photophobia and headaches. Other reactions reported less frequently included dryness of eyes, tearing and blurring of vision.

Dosage And Administration:

Two drops followed 5 minutes later by an additional 2 drops applied topically to the conjunctiva of each eye should be administered after the ophthalmic examination to reverse the diagnostic mydriasis. Dapiprazole hydrochloride ophthalmic solution should not be used in the same patient more frequently than once per week.

Directions For Preparing Eyedrops:

  • Use aseptic technique.Tear off aluminum seals, remove and discard rubber plugs from both drug and diluent vialsPour diluent into drug vial.Remove dropper assembly from its sterile wrapping and attach to the drug vial.Shake container for several minutes to ensure mixing.

How Supplied:

Dapiprazole hydrochloride ophthalmic solution, 0.5% - Sterile is supplied as an outer package (NDC 53020-265-01) containing:NDC 53020-255-01 single vial of dapiprazole hydrochloride (25 mg) lyophilized powderNDC 53020-245-01 single vial of diluent (5 mL)Single dropper for dispensing

Storage And Stability Of Eyedrops:

Once the ophthalmic solution has been reconstituted it may be stored at 20° - 25°C (68° - 77°F) [See USP Controlled Temperature] for 21 days. Discard any solution that is not clear and colorless.Updated: February 2019Manufactured by: Exela Pharma Sciences, LLC


Lenoir, NC 28645


Manufactured For:Baradaina, LLC


8780 W. Golf Road, Suite 304


Niles , Illinois 60714


Rx only

Principal Display-Container Label

SterileDapiprazole HCI Ophthalmic Solution 0.5% E Y E D R O P SRx only


For Use in the Eyes


5 mL


(when diluent is added)


​​



BARADAINA, LLC

* Please review the disclaimer below.

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