NDC 59651-066 Olopatadine Hydrochloride

Olopatadine Hydrochloride

NDC Product Code 59651-066

NDC Code: 59651-066

Proprietary Name: Olopatadine Hydrochloride 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: Olopatadine Hydrochloride 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

  • 59651 - Aurobindo Pharma Limited
    • 59651-066 - Olopatadine Hydrochloride

NDC 59651-066-05

Package Description: 1 BOTTLE in 1 CARTON > 2.5 mL in 1 BOTTLE

NDC Product Information

Olopatadine Hydrochloride with NDC 59651-066 is a a human prescription drug product labeled by Aurobindo Pharma Limited. The generic name of Olopatadine Hydrochloride is olopatadine hydrochloride. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Aurobindo Pharma Limited

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Olopatadine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OLOPATADINE HYDROCHLORIDE 2 mg/mL

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.

  • POVIDONE K30 (UNII: U725QWY32X)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Histamine Release - [PE] (Physiologic Effect)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Inhibitor - [EPC] (Established Pharmacologic Class)

Product Labeler Information

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

Labeler Name: Aurobindo Pharma Limited
Labeler Code: 59651
FDA Application Number: ANDA209995 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: 04-04-2019 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.

Olopatadine Hydrochloride 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

1 Indications And Usage

Olopatadine Hydrochloride Ophthalmic Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

2 Dosage And Administration

The recommended dose is one drop in each affected eye once a day.

3 Dosage Forms And Strengths

Ophthalmic solution 0.2%: each mL contains 2.22 mg of olopatadine hydrochloride.

4 Contraindications

None.

5 Warnings And Precautions

5.1    For topical ocular use only. Not for injection or oral use.5.2    Contamination of Tip and SolutionAs with any eye drop, to prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.5.3    Contact Lens UsePatients should be advised not to wear a contact lens if their eye is red.Olopatadine Hydrochloride Ophthalmic Solution, 0.2% should not be used to treat contact lens related irritation. The preservative in Olopatadine Hydrochloride Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling Olopatadine Hydrochloride Ophthalmic Solution, 0.2% before they insert their contact lenses.

6 Adverse Reactions

Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%.The following adverse experiences have been reported in 5% or less of patients:Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus.Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion.Some of these events were similar to the underlying disease being studied.

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the MROHD, during organogenesis showed a decrease in live fetuses. In addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. Further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

8.3 Nursing Mothers

Olopatadine has been identified in the milk of nursing rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olopatadine Hydrochloride Ophthalmic Solution, 0.2% is administered to a nursing mother.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

8.5 Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

11 Description

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is a sterile, clear, colorless to pale yellow ophthalmic solution containing olopatadine for topical administration to the eyes. Olopatadine hydrochloride USP is a white crystalline water-soluble powder with a molecular weight of 373.88 and a molecular formula of C21H23NO3 • HCl.The chemical structure is presented below: Chemical Name: 11-[(Z)-3-(Dimethylamino) propylidene]-6-11-dihydrodibenz[b,e] oxepin-2-acetic acid, hydrochlorideEach mL of Olopatadine Hydrochloride Ophthalmic Solution, USP contains: Active: 2.22 mg olopatadine hydrochloride USP equivalent to 2 mg olopatadine. Inactives: povidone; dibasic sodium phosphate; sodium chloride; edetate disodium; benzalkonium chloride 0.01% (preservative); hydrochloric acid/sodium hydroxide (adjust pH); and water for injection. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.

12.1 Mechanism Of Action

Olopatadine is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.

12.3 Pharmacokinetics

Systemic bioavailability data upon topical ocular administration of Olopatadine Hydrochloride Ophthalmic Solution are not available. Following topical ocular administration of olopatadine 0.15% ophthalmic solution in man, olopatadine was shown to have a low systemic exposure. Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (< 0.5 ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The elimination half-life in plasma following oral dosing was 8 to 12 hours, and elimination was predominantly through renal excretion. Approximately 60 to 70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Olopatadine administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 40 µL drop size and a 50 kg person, these doses were approximately 150,000 and 50,000 times higher than the maximum recommended ocular human dose (MROHD). No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test. Olopatadine administered to male and female rats at oral doses of approximately 100,000 times MROHD level resulted in a slight decrease in the fertility index and reduced implantation rate; no effects on reproductive function were observed at doses of approximately 15,000 times the MROHD level.

14 Clinical Studies

Results from clinical studies of up to 12 weeks duration demonstrate that Olopatadine Hydrochloride Ophthalmic Solution when dosed once a day is effective in the treatment of ocular itching associated with allergic conjunctivitis.

16 How Supplied/Storage And Handling

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is a clear, colorless to pale yellow solution supplied in a 5 mL white opaque LDPE bottle with LDPE nozzle and white color HDPE cap with a tamper-evident ring. 2.5 mL fill in 5 mL bottle                             NDC 59651-066-05 Storage Store at 2° to 25°C (36° to 77°F)

17 Patient Counseling Information

17.1  Topical Ophthalmic Use Only For topical ophthalmic administration only.17.2 Sterility of Dropper Tip Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.17.3 Concomitant Use of Contact Lenses Patients should be advised not to wear a contact lens if their eyes are red. Patients should be advised that Olopatadine Hydrochloride Ophthalmic Solution should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Olopatadine Hydrochloride Ophthalmic Solution. The preservative in Olopatadine Hydrochloride Ophthalmic Solution benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted following administration of Olopatadine Hydrochloride Ophthalmic Solution. Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by:Aurobindo Pharma LimitedHyderabad-500038, India

* Please review the disclaimer below.

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