RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "82667-021-05",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (82667-021-05)  / 3.5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "82667-0021-05",
      "ProductNDC": "82667-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Byqlovi",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "FOR SUSPENSION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20240304",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA218158",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260125",
      "SamplePackage": "N",
      "IndicationAndUsage": "BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery.",
      "Description": "BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, that has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β- methylpregna- 1,4-diene-3,20-dione 17-propionate and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32CIFO5 and a molecular weight of 467. BYQLOVI contains a sterile, anti-inflammatory corticosteroid for topical ophthalmic use. Each mL of BYQLOVI contains. ACTIVE: clobetasol propionate 0.5 mg (0.05%). INACTIVES: sodium chloride, hydrogenated soybean lecithin, citric acid, glycerin, poloxamer 407, polyvinyl alcohol, boric acid, edetate disodium dihydrate, methylcellulose, trisodium citrate, and water for injection. PRESERVATIVE: benzalkonium chloride 0.0036%."
    },
    {
      "NDCCode": "82667-021-00",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (82667-021-00)  / 3.5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "82667-0021-00",
      "ProductNDC": "82667-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Byqlovi",
      "NonProprietaryName": "Clobetasol Propionate",
      "DosageFormName": "FOR SUSPENSION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20240304",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA218158",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "CLOBETASOL PROPIONATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260125",
      "SamplePackage": "Y",
      "IndicationAndUsage": "BYQLOVI is indicated for the treatment of post-operative inflammation and pain following ocular surgery.",
      "Description": "BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, that has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β- methylpregna- 1,4-diene-3,20-dione 17-propionate and it has the following structural formula. Clobetasol propionate has the empirical formula C25H32CIFO5 and a molecular weight of 467. BYQLOVI contains a sterile, anti-inflammatory corticosteroid for topical ophthalmic use. Each mL of BYQLOVI contains. ACTIVE: clobetasol propionate 0.5 mg (0.05%). INACTIVES: sodium chloride, hydrogenated soybean lecithin, citric acid, glycerin, poloxamer 407, polyvinyl alcohol, boric acid, edetate disodium dihydrate, methylcellulose, trisodium citrate, and water for injection. PRESERVATIVE: benzalkonium chloride 0.0036%."
    },
    {
      "NDCCode": "82667-011-05",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82667-011-05)  / 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "82667-0011-05",
      "ProductNDC": "82667-011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tobradex St",
      "NonProprietaryName": "Tobramycin / Dexamethasone",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20250331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050818",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "TOBRAMYCIN; DEXAMETHASONE",
      "StrengthNumber": "3; .5",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250331",
      "SamplePackage": "N",
      "IndicationAndUsage": "TOBRADEX ST ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococci, including S. aureusand S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant isolates. Streptococci, including some Group A and other beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris isolates, Haemophilus influenzae, H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, and some Neisseria species.",
      "Description": "TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05% is a sterile, isotonic, white, aqueous antibiotic and steroid suspension with a pH of approximately 5.7 and an osmolality of approximately 290 mOsm/kg. The chemical name of tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy- L-streptamine. It has a molecular formula of C 18H 37N 5O 9and a molecular weight of 467.52 g/mol. The chemical structure is:. The chemical name of dexamethasone is 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. It has a molecular formula of C 22H 29FO 5and a molecular weight of 392.47 g/mol. The chemical structure is:. Each mL of TOBRADEX ST contains: Actives:tobramycin 3 mg and dexamethasone 0.5 mg. Preservative:benzalkonium chloride 0.1 mg. Inactives:edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), propylene glycol, purified water, sodium chloride, sodium sulfate, tyloxapol, and xanthan gum."
    },
    {
      "NDCCode": "82667-012-05",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (82667-012-05)  / 15 mL in 1 BOTTLE, GLASS",
      "NDC11Code": "82667-0012-05",
      "ProductNDC": "82667-012",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Natacyn",
      "NonProprietaryName": "Natamycin",
      "DosageFormName": "SUSPENSION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20241101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050514",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "NATAMYCIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Polyene Antimicrobial [EPC], Polyenes [CS]",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241101",
      "SamplePackage": "N",
      "IndicationAndUsage": "NATACYN (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solanikeratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the in vitroactivity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.",
      "Description": "NATACYN (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration. Each mL of NATACYN (natamycin ophthalmic suspension) contains: Active:natamycin 5% (50 mg). Preservative:benzalkonium chloride 0.02%. Inactive:sodium hydroxide and/or hydrochloric acid (neutralized to adjust the pH), purified water. The active ingredient is represented by the chemical structure. Established Name:Natamycin. Molecular Formula:C 33H 47NO 13. Molecular Weight:665.73 g/mol. Chemical Name:Stereoisomer of 22-[(3-amino-3,6-dideoxy- β-D-mannopyranosyl)oxy]-1,3,26- trihydroxy-12- methyl-10-oxo-6,11,28- trioxatricyclo[22.3.1.05,7] octacosa-8,14,16,18,20-pentaene-25- carboxylic acid. Other:Pimaricin. The pH range is 5.0-7.5."
    },
    {
      "NDCCode": "82667-018-05",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (82667-018-05)  / .05 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "82667-0018-05",
      "ProductNDC": "82667-018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Byooviz",
      "NonProprietaryName": "Ranibizumab-nuna",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVITREAL",
      "StartMarketingDate": "20260101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761202",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "RANIBIZUMAB",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20260101",
      "SamplePackage": "N",
      "IndicationAndUsage": "BYOOVIZ is indicated for the treatment of patients with.",
      "Description": "BYOOVIZ (ranibizumab-nuna) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-nuna binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-nuna, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. BYOOVIZ (ranibizumab-nuna) injection is a sterile, clear to slightly opalescent and colorless to pale yellow solution in a single-dose glass vial for intravitreal use. BYOOVIZ is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL BYOOVIZ (0.5 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5."
    },
    {
      "NDCCode": "82667-100-05",
      "PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (82667-100-05) ",
      "NDC11Code": "82667-0100-05",
      "ProductNDC": "82667-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Maxitrol",
      "NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
      "DosageFormName": "SUSPENSION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19641115",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050023",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
      "StrengthNumber": "3.5; 10000; 1",
      "StrengthUnit": "mg/mL; [USP'U]/mL; mg/mL",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-10-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231101",
      "SamplePackage": "N",
      "IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli,Haemophilusinfluenzae,Klebsiella/Enterobacterspecies, Neisseriaspecies, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescensand S treptococci, including Streptococcus pneumoniae.",
      "Description": "MAXITROL ®(neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is:. Molecular Weight = 392.45 g/mol. C22H29FO5. Established name:dexamethasone. Chemical name:pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. Neomycin B (R 1=H, R 2=CH 2NH 2). Neomycin C (R 1=CH 2NH 2, R 2=H). The structural formula for polymyxin B sulfate is. Each mL of MAXITROL ®(neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) contains: Actives:neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives:benzalkonium chloride 0.004% (preservative), hydrochloric acid and/or sodium hydroxide (to adjust pH), hypromellose 2910 0.5%, polysorbate 20, purified water, sodium chloride."
    },
    {
      "NDCCode": "82667-200-05",
      "PackageDescription": "5 POUCH in 1 CARTON (82667-200-05)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "82667-0200-05",
      "ProductNDC": "82667-200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Iopidine 1%",
      "NonProprietaryName": "Apraclonidine Hydrochloride Ophthalmic Solution",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20230801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019779",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "APRACLONIDINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260501",
      "SamplePackage": "N",
      "IndicationAndUsage": "IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.",
      "Description": "IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off‑white powder and is highly soluble in water. Its chemical name is 2-[(4‑amino-2,6 dichlorophenyl)imino] imidazolidine monohydrochloride with an empirical formula of C 9H 11Cl 3N 4and a molecular weight of 281.6. The chemical structure of apraclonidine hydrochloride is:. Each mL of IOPIDINE 1% Ophthalmic Solution contains:. Actives: apraclonidine hydrochloride 11.5 mg equivalent to apraclonidine base 10 mg. Inactives:sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4‑7.8), purified water and benzalkonium chloride 0.01% (preservative). Osmolality is 260‑320 mOsm."
    },
    {
      "NDCCode": "82667-300-05",
      "PackageDescription": "5 POUCH in 1 CARTON (82667-300-05)  / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL",
      "NDC11Code": "82667-0300-05",
      "ProductNDC": "82667-300",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Iheezo",
      "NonProprietaryName": "Chloroprocaine Hydrochloride Ophthalmic Gel",
      "DosageFormName": "GEL",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20220927",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216227",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "CHLOROPROCAINE HYDROCHLORIDE",
      "StrengthNumber": "24",
      "StrengthUnit": "mg/800mg",
      "Pharm_Classes": "Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260302",
      "SamplePackage": "N",
      "IndicationAndUsage": "IHEEZO TMis indicated for ocular surface anesthesia.",
      "Description": "IHEEZO TMis a sterile, single-patient‑use ophthalmic gel preparation for topical ocular anesthesia containing chloroprocaine hydrochloride as the active pharmaceutical ingredient. Chloroprocaine hydrochloride is an ester anesthetic. It is a water-soluble white crystalline powder and its chemical name is 2-(Diethylamino)ethyl 4‑amino-2-chlorobenzoate monohydrochloride. The molecular weight is 307.22 and the molecular formula is C 13H 19ClN 2O 2·HCl. It is represented by the following structural formula:. IHEEZO TMcontains:. Active: 30 mg of chloroprocaine hydrochloride (equivalent to 26 mg of chloroprocaine) per gram of gel. Inactive ingredients: Hydroxyethyl Cellulose (HEC), and Water for Injection. The pH may be adjusted to 3.0 to 5.0 with Hydrochloric Acid. This product does not contain an antimicrobial preservative."
    },
    {
      "NDCCode": "82667-600-05",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05)  / 5 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "82667-0600-05",
      "ProductNDC": "82667-600",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Maxidex",
      "NonProprietaryName": "Dexamethasone",
      "DosageFormName": "FOR SUSPENSION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20250407",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA013422",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "DEXAMETHASONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250407",
      "SamplePackage": "N",
      "IndicationAndUsage": "Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.",
      "Description": "MAXIDEX (dexamethasone ophthalmic suspension) 0.1% is an adrenocortical steroid prepared as a sterile topical ophthalmic suspension. The active ingredient is represented by the chemical structure. Chemical name: Pregna-1,4-diene-3,20-dione,9-fluoro-11,17,21-trihydroxy-16-methyl-,(11β,16α)-. Each mL of MAXIDEX (dexamethasone ophthalmic suspension) 0.1% contains: Active:dexamethasone 0.1%. Preservative:benzalkonium chloride 0.01%. Vehicle:hypromellose 0.5%. Inactives:citric acid and/or sodium hydroxide (to adjust pH), dibasic sodium phosphate, edetate disodium, polysorbate 80, purified water, and sodium chloride."
    },
    {
      "NDCCode": "82667-015-24",
      "PackageDescription": "1 POUCH in 1 CARTON (82667-015-24)  / 30 VIAL, SINGLE-USE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-USE",
      "NDC11Code": "82667-0015-24",
      "ProductNDC": "82667-015",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zerviate",
      "NonProprietaryName": "Cetirizine",
      "DosageFormName": "FOR SOLUTION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20250430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA208694",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "CETIRIZINE",
      "StrengthNumber": "2.4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZERVIATE ® (cetirizine ophthalmic solution) 0.24% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.",
      "Description": "ZERVIATE ® is a sterile ophthalmic solution containing cetirizine, which is a histamine-1 (H1) receptor antagonist, for topical administration to the eyes. Cetirizine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 461.8 and a molecular formula of C 21H 25ClN 2O 32HCl. The chemical structure is presented below:. Chemical Name. ( RS)-2-[2-[4-[(4-Chlorophenyl) phenylmethyl] piperazin-1-yl] ethoxy] acetic acid, dihydrochloride. Each mL of ZERVIATE ® contains an active ingredient [cetirizine 2.40 mg (equivalent to 2.85 mg of cetirizine hydrochloride)] and the following inactive ingredients: benzalkonium chloride 0.010% (preservative); glycerin; sodium phosphate, dibasic; edetate disodium; polyethylene glycol 400; polysorbate 80; hypromellose; hydrochloric acid/sodiumhydroxide (to adjust pH); and water for injection. ZERVIATE ®solution has a pH of approximately 7.0 and osmolality of approximately 300 mOsm/kg."
    },
    {
      "NDCCode": "82667-200-01",
      "PackageDescription": "12 POUCH in 1 CARTON (82667-200-01)  / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "82667-0200-01",
      "ProductNDC": "82667-200",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Iopidine 1%",
      "NonProprietaryName": "Apraclonidine Hydrochloride Ophthalmic Solution",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20230801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019779",
      "LabelerName": "Harrow Eye, LLC",
      "SubstanceName": "APRACLONIDINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-05-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230801",
      "SamplePackage": "N",
      "IndicationAndUsage": "IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.",
      "Description": "IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off‑white powder and is highly soluble in water. Its chemical name is 2-[(4‑amino-2,6 dichlorophenyl)imino] imidazolidine monohydrochloride with an empirical formula of C 9H 11Cl 3N 4and a molecular weight of 281.6. The chemical structure of apraclonidine hydrochloride is:. Each mL of IOPIDINE 1% Ophthalmic Solution contains:. Actives: apraclonidine hydrochloride 11.5 mg equivalent to apraclonidine base 10 mg. Inactives:sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4‑7.8), purified water and benzalkonium chloride 0.01% (preservative). Osmolality is 260‑320 mOsm."
    },
    {
      "NDCCode": "10402-021-05",
      "PackageDescription": "5 kg in 1 DRUM (10402-021-05)",
      "NDC11Code": "10402-0021-05",
      "ProductNDC": "10402-021",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cephalothin Sodium",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110628",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Antibioticos do Brasil Ltda.",
      "SubstanceName": "CEPHALOTHIN SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2019-11-09",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "11084-021-05",
      "PackageDescription": "3.78 L in 1 BOTTLE, PLASTIC (11084-021-05) ",
      "NDC11Code": "11084-0021-05",
      "ProductNDC": "11084-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foam",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "SC Johnson Professional USA Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "g/L",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170801",
      "SamplePackage": "N",
      "IndicationAndUsage": "for handwashing to reduce bacteria on the skin."
    },
    {
      "NDCCode": "11086-021-05",
      "PackageDescription": "284 g in 1 PACKAGE (11086-021-05) ",
      "NDC11Code": "11086-0021-05",
      "ProductNDC": "11086-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triple",
      "ProprietaryNameSuffix": "Medicated For Diaper Rash",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131030",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Summers Laboratories Inc",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "12.8",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20131030",
      "SamplePackage": "N",
      "IndicationAndUsage": "HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS."
    },
    {
      "NDCCode": "11086-021-15",
      "PackageDescription": "1 TUBE in 1 BOX (11086-021-15)  > 99 g in 1 TUBE (11086-021-05)",
      "NDC11Code": "11086-0021-15",
      "ProductNDC": "11086-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triple",
      "ProprietaryNameSuffix": "Medicated For Diaper Rash",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20131030",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "Summers Laboratories Inc",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "12.8",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-21",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "13107-021-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (13107-021-05) ",
      "NDC11Code": "13107-0021-05",
      "ProductNDC": "13107-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120411",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201013",
      "LabelerName": "Aurolife Pharma, LLC",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "10; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120411",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy[ see WARNINGS], reserve opioid analgesics, including hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
      "Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4, 5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table.Each hydrocodone bitartrate and acetaminophen tablet contains. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Meets USP Dissolution Test 1."
    },
    {
      "NDCCode": "13668-021-05",
      "PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-021-05) ",
      "NDC11Code": "13668-0021-05",
      "ProductNDC": "13668-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alfuzosin Hydrochloride",
      "NonProprietaryName": "Alfuzosin Hydrochloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110718",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079054",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20110718",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "16714-021-05",
      "PackageDescription": "500 TABLET in 1 BOTTLE (16714-021-05)",
      "NDC11Code": "16714-0021-05",
      "ProductNDC": "16714-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091214",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078213",
      "LabelerName": "Northstar RxLLC",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-09-05"
    },
    {
      "NDCCode": "16864-021-05",
      "PackageDescription": "454 g in 1 JAR (16864-021-05) ",
      "NDC11Code": "16864-0021-05",
      "ProductNDC": "16864-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Triple Diaper Rash",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Advantice Health, LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "12.8",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-03-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210515",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps treat and prevent diaper rash. protects chafed skin due to diaper rash and helps protect from wetness."
    },
    {
      "NDCCode": "23155-021-05",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (23155-021-05) ",
      "NDC11Code": "23155-0021-05",
      "ProductNDC": "23155-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketoprofen",
      "NonProprietaryName": "Ketoprofen",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200128",
      "EndMarketingDate": "20220131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074014",
      "LabelerName": "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.",
      "SubstanceName": "KETOPROFEN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200128",
      "EndMarketingDatePackage": "20220131",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "25225-021-05",
      "PackageDescription": "500 g in 1 BOTTLE, PLASTIC (25225-021-05)",
      "NDC11Code": "25225-0021-05",
      "ProductNDC": "25225-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunkissed Honeydew Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101113",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Unique Holding Group Inc",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "31722-021-05",
      "PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-021-05) ",
      "NDC11Code": "31722-0021-05",
      "ProductNDC": "31722-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Divalproex Sodium",
      "NonProprietaryName": "Divalproex Sodium",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230923",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215527",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "DIVALPROEX SODIUM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230926",
      "SamplePackage": "N",
      "IndicationAndUsage": "Divalproex sodium extended-release tablets are indicated for:   Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 1.1)   Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2)   Prophylaxis of migraine headaches ( 1.3).",
      "Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure.   Divalproex sodium USP occurs as a white to off-white powder with a characteristic odor.  Divalproex sodium extended-release tablets USP 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid.  Inactive Ingredients  Hypromellose, microcrystalline cellulose, silicon dioxide. The film-coating contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.  FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "42806-021-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42806-021-05)",
      "NDC11Code": "42806-0021-05",
      "ProductNDC": "42806-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Citalopram",
      "NonProprietaryName": "Citalopram",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110520",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077045",
      "LabelerName": "Epic Pharma, LLC",
      "SubstanceName": "CITALOPRAM HYDROBROMIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "44397-021-05",
      "PackageDescription": "6900 L in 1 CYLINDER (44397-021-05)",
      "NDC11Code": "44397-0021-05",
      "ProductNDC": "44397-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrous Oxide",
      "NonProprietaryName": "Nitrous Oxide",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19740101",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205704",
      "LabelerName": "Argyle Welding Supply Company, Inc.",
      "SubstanceName": "NITROUS OXIDE",
      "StrengthNumber": "99",
      "StrengthUnit": "L/100L",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "45861-021-05",
      "PackageDescription": "5 kg in 1 DRUM (45861-021-05)",
      "NDC11Code": "45861-0021-05",
      "ProductNDC": "45861-021",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20130509",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Pharmaceutica North America, Inc",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "49643-021-05",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-021-05) ",
      "NDC11Code": "49643-0021-05",
      "ProductNDC": "49643-021",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Sisal",
      "NonProprietaryName": "Sisal",
      "DosageFormName": "INJECTION",
      "RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740312",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102211",
      "LabelerName": "Allermed Laboratories, Inc.",
      "SubstanceName": "AGAVE SISALANA FIBER",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Fiber Allergenic Extract [EPC], Plant Proteins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19740312",
      "SamplePackage": "N",
      "IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
      "Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
    },
    {
      "NDCCode": "49781-021-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49781-021-05)  > 150 mL in 1 BOTTLE",
      "NDC11Code": "49781-0021-05",
      "ProductNDC": "49781-021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Leader Childrens Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140305",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074937",
      "LabelerName": "Cardinal Health",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "50383-021-05",
      "PackageDescription": "1 BOTTLE in 1 CARTON (50383-021-05)  > 5 mL in 1 BOTTLE",
      "NDC11Code": "50383-0021-05",
      "ProductNDC": "50383-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Timolol Maleate",
      "NonProprietaryName": "Timolol Maleate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20020910",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075163",
      "LabelerName": "Akorn",
      "SubstanceName": "TIMOLOL MALEATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20020910",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "52119-021-05",
      "PackageDescription": "5 kg in 1 DRUM (52119-021-05) ",
      "NDC11Code": "52119-0021-05",
      "ProductNDC": "52119-021",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Melatonin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20190701",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Swati Spentose Private Limited",
      "SubstanceName": "MELATONIN",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "01-JUL-19"
    },
    {
      "NDCCode": "53746-021-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (53746-021-05) ",
      "NDC11Code": "53746-0021-05",
      "ProductNDC": "53746-021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Escitalopram Oxalate",
      "NonProprietaryName": "Escitalopram Oxalate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170517",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205619",
      "LabelerName": "Amneal Pharmaceuticals of New York LLC",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-11-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170517",
      "SamplePackage": "N",
      "IndicationAndUsage": "Escitalopram tablets are indicated for the treatment of: : 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. , 2 generalized anxiety disorder (GAD) in adults. .",
      "Description": "Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    }
  ]
}
                    

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    <ProprietaryName>Byqlovi</ProprietaryName>
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    <MarketingCategoryName>NDA</MarketingCategoryName>
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    <LabelerName>Harrow Eye, LLC</LabelerName>
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    <StrengthUnit>mg/mL</StrengthUnit>
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    <ProductNDC>82667-011</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tobradex St</ProprietaryName>
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    <MarketingCategoryName>NDA</MarketingCategoryName>
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    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>TOBRAMYCIN; DEXAMETHASONE</SubstanceName>
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    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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    <SamplePackage>N</SamplePackage>
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    <Description>TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05% is a sterile, isotonic, white, aqueous antibiotic and steroid suspension with a pH of approximately 5.7 and an osmolality of approximately 290 mOsm/kg. The chemical name of tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino- 2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy- L-streptamine. It has a molecular formula of C 18H 37N 5O 9and a molecular weight of 467.52 g/mol. The chemical structure is:. The chemical name of dexamethasone is 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. It has a molecular formula of C 22H 29FO 5and a molecular weight of 392.47 g/mol. The chemical structure is:. Each mL of TOBRADEX ST contains: Actives:tobramycin 3 mg and dexamethasone 0.5 mg. Preservative:benzalkonium chloride 0.1 mg. Inactives:edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), propylene glycol, purified water, sodium chloride, sodium sulfate, tyloxapol, and xanthan gum.</Description>
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    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (82667-012-05)  / 15 mL in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>82667-0012-05</NDC11Code>
    <ProductNDC>82667-012</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Natacyn</ProprietaryName>
    <NonProprietaryName>Natamycin</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20241101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050514</ApplicationNumber>
    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>NATAMYCIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Polyene Antimicrobial [EPC], Polyenes [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NATACYN (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solanikeratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the in vitroactivity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.</IndicationAndUsage>
    <Description>NATACYN (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration. Each mL of NATACYN (natamycin ophthalmic suspension) contains: Active:natamycin 5% (50 mg). Preservative:benzalkonium chloride 0.02%. Inactive:sodium hydroxide and/or hydrochloric acid (neutralized to adjust the pH), purified water. The active ingredient is represented by the chemical structure. Established Name:Natamycin. Molecular Formula:C 33H 47NO 13. Molecular Weight:665.73 g/mol. Chemical Name:Stereoisomer of 22-[(3-amino-3,6-dideoxy- β-D-mannopyranosyl)oxy]-1,3,26- trihydroxy-12- methyl-10-oxo-6,11,28- trioxatricyclo[22.3.1.05,7] octacosa-8,14,16,18,20-pentaene-25- carboxylic acid. Other:Pimaricin. The pH range is 5.0-7.5.</Description>
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  <NDC>
    <NDCCode>82667-018-05</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (82667-018-05)  / .05 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>82667-0018-05</NDC11Code>
    <ProductNDC>82667-018</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Byooviz</ProprietaryName>
    <NonProprietaryName>Ranibizumab-nuna</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVITREAL</RouteName>
    <StartMarketingDate>20260101</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761202</ApplicationNumber>
    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>RANIBIZUMAB</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BYOOVIZ is indicated for the treatment of patients with.</IndicationAndUsage>
    <Description>BYOOVIZ (ranibizumab-nuna) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-nuna binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-nuna, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. BYOOVIZ (ranibizumab-nuna) injection is a sterile, clear to slightly opalescent and colorless to pale yellow solution in a single-dose glass vial for intravitreal use. BYOOVIZ is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL BYOOVIZ (0.5 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.</Description>
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  <NDC>
    <NDCCode>82667-100-05</NDCCode>
    <PackageDescription>5 mL in 1 BOTTLE, PLASTIC (82667-100-05) </PackageDescription>
    <NDC11Code>82667-0100-05</NDC11Code>
    <ProductNDC>82667-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Maxitrol</ProprietaryName>
    <NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19641115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050023</ApplicationNumber>
    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE</SubstanceName>
    <StrengthNumber>3.5; 10000; 1</StrengthNumber>
    <StrengthUnit>mg/mL; [USP'U]/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli,Haemophilusinfluenzae,Klebsiella/Enterobacterspecies, Neisseriaspecies, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescensand S treptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
    <Description>MAXITROL ®(neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is:. Molecular Weight = 392.45 g/mol. C22H29FO5. Established name:dexamethasone. Chemical name:pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is. Neomycin B (R 1=H, R 2=CH 2NH 2). Neomycin C (R 1=CH 2NH 2, R 2=H). The structural formula for polymyxin B sulfate is. Each mL of MAXITROL ®(neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) contains: Actives:neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives:benzalkonium chloride 0.004% (preservative), hydrochloric acid and/or sodium hydroxide (to adjust pH), hypromellose 2910 0.5%, polysorbate 20, purified water, sodium chloride.</Description>
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    <NDCCode>82667-200-05</NDCCode>
    <PackageDescription>5 POUCH in 1 CARTON (82667-200-05)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>82667-0200-05</NDC11Code>
    <ProductNDC>82667-200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iopidine 1%</ProprietaryName>
    <NonProprietaryName>Apraclonidine Hydrochloride Ophthalmic Solution</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019779</ApplicationNumber>
    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>APRACLONIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.</IndicationAndUsage>
    <Description>IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off‑white powder and is highly soluble in water. Its chemical name is 2-[(4‑amino-2,6 dichlorophenyl)imino] imidazolidine monohydrochloride with an empirical formula of C 9H 11Cl 3N 4and a molecular weight of 281.6. The chemical structure of apraclonidine hydrochloride is:. Each mL of IOPIDINE 1% Ophthalmic Solution contains:. Actives: apraclonidine hydrochloride 11.5 mg equivalent to apraclonidine base 10 mg. Inactives:sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4‑7.8), purified water and benzalkonium chloride 0.01% (preservative). Osmolality is 260‑320 mOsm.</Description>
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    <PackageDescription>5 POUCH in 1 CARTON (82667-300-05)  / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL</PackageDescription>
    <NDC11Code>82667-0300-05</NDC11Code>
    <ProductNDC>82667-300</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iheezo</ProprietaryName>
    <NonProprietaryName>Chloroprocaine Hydrochloride Ophthalmic Gel</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220927</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA216227</ApplicationNumber>
    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>CHLOROPROCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>24</StrengthNumber>
    <StrengthUnit>mg/800mg</StrengthUnit>
    <Pharm_Classes>Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260302</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>IHEEZO TMis indicated for ocular surface anesthesia.</IndicationAndUsage>
    <Description>IHEEZO TMis a sterile, single-patient‑use ophthalmic gel preparation for topical ocular anesthesia containing chloroprocaine hydrochloride as the active pharmaceutical ingredient. Chloroprocaine hydrochloride is an ester anesthetic. It is a water-soluble white crystalline powder and its chemical name is 2-(Diethylamino)ethyl 4‑amino-2-chlorobenzoate monohydrochloride. The molecular weight is 307.22 and the molecular formula is C 13H 19ClN 2O 2·HCl. It is represented by the following structural formula:. IHEEZO TMcontains:. Active: 30 mg of chloroprocaine hydrochloride (equivalent to 26 mg of chloroprocaine) per gram of gel. Inactive ingredients: Hydroxyethyl Cellulose (HEC), and Water for Injection. The pH may be adjusted to 3.0 to 5.0 with Hydrochloric Acid. This product does not contain an antimicrobial preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>82667-600-05</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05)  / 5 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>82667-0600-05</NDC11Code>
    <ProductNDC>82667-600</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Maxidex</ProprietaryName>
    <NonProprietaryName>Dexamethasone</NonProprietaryName>
    <DosageFormName>FOR SUSPENSION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250407</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA013422</ApplicationNumber>
    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>DEXAMETHASONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.</IndicationAndUsage>
    <Description>MAXIDEX (dexamethasone ophthalmic suspension) 0.1% is an adrenocortical steroid prepared as a sterile topical ophthalmic suspension. The active ingredient is represented by the chemical structure. Chemical name: Pregna-1,4-diene-3,20-dione,9-fluoro-11,17,21-trihydroxy-16-methyl-,(11β,16α)-. Each mL of MAXIDEX (dexamethasone ophthalmic suspension) 0.1% contains: Active:dexamethasone 0.1%. Preservative:benzalkonium chloride 0.01%. Vehicle:hypromellose 0.5%. Inactives:citric acid and/or sodium hydroxide (to adjust pH), dibasic sodium phosphate, edetate disodium, polysorbate 80, purified water, and sodium chloride.</Description>
  </NDC>
  <NDC>
    <NDCCode>82667-015-24</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (82667-015-24)  / 30 VIAL, SINGLE-USE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>82667-0015-24</NDC11Code>
    <ProductNDC>82667-015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zerviate</ProprietaryName>
    <NonProprietaryName>Cetirizine</NonProprietaryName>
    <DosageFormName>FOR SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250430</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208694</ApplicationNumber>
    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>CETIRIZINE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZERVIATE ® (cetirizine ophthalmic solution) 0.24% is indicated for the treatment of ocular itching associated with allergic conjunctivitis.</IndicationAndUsage>
    <Description>ZERVIATE ® is a sterile ophthalmic solution containing cetirizine, which is a histamine-1 (H1) receptor antagonist, for topical administration to the eyes. Cetirizine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 461.8 and a molecular formula of C 21H 25ClN 2O 32HCl. The chemical structure is presented below:. Chemical Name. ( RS)-2-[2-[4-[(4-Chlorophenyl) phenylmethyl] piperazin-1-yl] ethoxy] acetic acid, dihydrochloride. Each mL of ZERVIATE ® contains an active ingredient [cetirizine 2.40 mg (equivalent to 2.85 mg of cetirizine hydrochloride)] and the following inactive ingredients: benzalkonium chloride 0.010% (preservative); glycerin; sodium phosphate, dibasic; edetate disodium; polyethylene glycol 400; polysorbate 80; hypromellose; hydrochloric acid/sodiumhydroxide (to adjust pH); and water for injection. ZERVIATE ®solution has a pH of approximately 7.0 and osmolality of approximately 300 mOsm/kg.</Description>
  </NDC>
  <NDC>
    <NDCCode>82667-200-01</NDCCode>
    <PackageDescription>12 POUCH in 1 CARTON (82667-200-01)  / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>82667-0200-01</NDC11Code>
    <ProductNDC>82667-200</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Iopidine 1%</ProprietaryName>
    <NonProprietaryName>Apraclonidine Hydrochloride Ophthalmic Solution</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019779</ApplicationNumber>
    <LabelerName>Harrow Eye, LLC</LabelerName>
    <SubstanceName>APRACLONIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.</IndicationAndUsage>
    <Description>IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off‑white powder and is highly soluble in water. Its chemical name is 2-[(4‑amino-2,6 dichlorophenyl)imino] imidazolidine monohydrochloride with an empirical formula of C 9H 11Cl 3N 4and a molecular weight of 281.6. The chemical structure of apraclonidine hydrochloride is:. Each mL of IOPIDINE 1% Ophthalmic Solution contains:. Actives: apraclonidine hydrochloride 11.5 mg equivalent to apraclonidine base 10 mg. Inactives:sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4‑7.8), purified water and benzalkonium chloride 0.01% (preservative). Osmolality is 260‑320 mOsm.</Description>
  </NDC>
  <NDC>
    <NDCCode>10402-021-05</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (10402-021-05)</PackageDescription>
    <NDC11Code>10402-0021-05</NDC11Code>
    <ProductNDC>10402-021</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cephalothin Sodium</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110628</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Antibioticos do Brasil Ltda.</LabelerName>
    <SubstanceName>CEPHALOTHIN SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2019-11-09</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>11084-021-05</NDCCode>
    <PackageDescription>3.78 L in 1 BOTTLE, PLASTIC (11084-021-05) </PackageDescription>
    <NDC11Code>11084-0021-05</NDC11Code>
    <ProductNDC>11084-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Antibacterial Foam</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>SC Johnson Professional USA Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>g/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for handwashing to reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11086-021-05</NDCCode>
    <PackageDescription>284 g in 1 PACKAGE (11086-021-05) </PackageDescription>
    <NDC11Code>11086-0021-05</NDC11Code>
    <ProductNDC>11086-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triple</ProprietaryName>
    <ProprietaryNameSuffix>Medicated For Diaper Rash</ProprietaryNameSuffix>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131030</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Summers Laboratories Inc</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>12.8</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11086-021-15</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (11086-021-15)  &gt; 99 g in 1 TUBE (11086-021-05)</PackageDescription>
    <NDC11Code>11086-0021-15</NDC11Code>
    <ProductNDC>11086-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triple</ProprietaryName>
    <ProprietaryNameSuffix>Medicated For Diaper Rash</ProprietaryNameSuffix>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131030</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>Summers Laboratories Inc</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>12.8</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-21</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>13107-021-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (13107-021-05) </PackageDescription>
    <NDC11Code>13107-0021-05</NDC11Code>
    <ProductNDC>13107-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201013</ApplicationNumber>
    <LabelerName>Aurolife Pharma, LLC</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy[ see WARNINGS], reserve opioid analgesics, including hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4, 5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table.Each hydrocodone bitartrate and acetaminophen tablet contains. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Meets USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>13668-021-05</NDCCode>
    <PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-021-05) </PackageDescription>
    <NDC11Code>13668-0021-05</NDC11Code>
    <ProductNDC>13668-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110718</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079054</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ALFUZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110718</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>16714-021-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (16714-021-05)</PackageDescription>
    <NDC11Code>16714-0021-05</NDC11Code>
    <ProductNDC>16714-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078213</ApplicationNumber>
    <LabelerName>Northstar RxLLC</LabelerName>
    <SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-09-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>16864-021-05</NDCCode>
    <PackageDescription>454 g in 1 JAR (16864-021-05) </PackageDescription>
    <NDC11Code>16864-0021-05</NDC11Code>
    <ProductNDC>16864-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Triple Diaper Rash</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210515</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Advantice Health, LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>12.8</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps treat and prevent diaper rash. protects chafed skin due to diaper rash and helps protect from wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>23155-021-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (23155-021-05) </PackageDescription>
    <NDC11Code>23155-0021-05</NDC11Code>
    <ProductNDC>23155-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketoprofen</ProprietaryName>
    <NonProprietaryName>Ketoprofen</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200128</StartMarketingDate>
    <EndMarketingDate>20220131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074014</ApplicationNumber>
    <LabelerName>Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.</LabelerName>
    <SubstanceName>KETOPROFEN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200128</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>25225-021-05</NDCCode>
    <PackageDescription>500 g in 1 BOTTLE, PLASTIC (25225-021-05)</PackageDescription>
    <NDC11Code>25225-0021-05</NDC11Code>
    <ProductNDC>25225-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunkissed Honeydew Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101113</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Unique Holding Group Inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>31722-021-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-021-05) </PackageDescription>
    <NDC11Code>31722-0021-05</NDC11Code>
    <ProductNDC>31722-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Divalproex Sodium</ProprietaryName>
    <NonProprietaryName>Divalproex Sodium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230923</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215527</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DIVALPROEX SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Divalproex sodium extended-release tablets are indicated for:   Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 1.1)   Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2)   Prophylaxis of migraine headaches ( 1.3).</IndicationAndUsage>
    <Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure.   Divalproex sodium USP occurs as a white to off-white powder with a characteristic odor.  Divalproex sodium extended-release tablets USP 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid.  Inactive Ingredients  Hypromellose, microcrystalline cellulose, silicon dioxide. The film-coating contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.  FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42806-021-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42806-021-05)</PackageDescription>
    <NDC11Code>42806-0021-05</NDC11Code>
    <ProductNDC>42806-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077045</ApplicationNumber>
    <LabelerName>Epic Pharma, LLC</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>44397-021-05</NDCCode>
    <PackageDescription>6900 L in 1 CYLINDER (44397-021-05)</PackageDescription>
    <NDC11Code>44397-0021-05</NDC11Code>
    <ProductNDC>44397-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrous Oxide</ProprietaryName>
    <NonProprietaryName>Nitrous Oxide</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19740101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205704</ApplicationNumber>
    <LabelerName>Argyle Welding Supply Company, Inc.</LabelerName>
    <SubstanceName>NITROUS OXIDE</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>45861-021-05</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (45861-021-05)</PackageDescription>
    <NDC11Code>45861-0021-05</NDC11Code>
    <ProductNDC>45861-021</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20130509</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Pharmaceutica North America, Inc</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49643-021-05</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-021-05) </PackageDescription>
    <NDC11Code>49643-0021-05</NDC11Code>
    <ProductNDC>49643-021</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Sisal</ProprietaryName>
    <NonProprietaryName>Sisal</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740312</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102211</ApplicationNumber>
    <LabelerName>Allermed Laboratories, Inc.</LabelerName>
    <SubstanceName>AGAVE SISALANA FIBER</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Fiber Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19740312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
    <Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
  </NDC>
  <NDC>
    <NDCCode>49781-021-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49781-021-05)  &gt; 150 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>49781-0021-05</NDC11Code>
    <ProductNDC>49781-021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Leader Childrens Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140305</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074937</ApplicationNumber>
    <LabelerName>Cardinal Health</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>50383-021-05</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (50383-021-05)  &gt; 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>50383-0021-05</NDC11Code>
    <ProductNDC>50383-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20020910</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075163</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020910</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52119-021-05</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (52119-021-05) </PackageDescription>
    <NDC11Code>52119-0021-05</NDC11Code>
    <ProductNDC>52119-021</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Melatonin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190701</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Swati Spentose Private Limited</LabelerName>
    <SubstanceName>MELATONIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JUL-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>53746-021-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (53746-021-05) </PackageDescription>
    <NDC11Code>53746-0021-05</NDC11Code>
    <ProductNDC>53746-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205619</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram tablets are indicated for the treatment of: : 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. , 2 generalized anxiety disorder (GAD) in adults. .</IndicationAndUsage>
    <Description>Escitalopram tablet contains escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate and insoluble in heptane. Escitalopram tablets, USP are film-coated, round tablets containing 6.387 mg, 12.774 mg, 25.549 mg escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyanisole, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>82667-021-05</NDCCode><ProprietaryName>Byqlovi</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>82667-021-00</NDCCode><ProprietaryName>Byqlovi</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>82667-011-05</NDCCode><ProprietaryName>Tobradex St</ProprietaryName><NonProprietaryName>Tobramycin / Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>82667-012-05</NDCCode><ProprietaryName>Natacyn</ProprietaryName><NonProprietaryName>Natamycin</NonProprietaryName></NDC><NDC><NDCCode>82667-018-05</NDCCode><ProprietaryName>Byooviz</ProprietaryName><NonProprietaryName>Ranibizumab-nuna</NonProprietaryName></NDC><NDC><NDCCode>82667-100-05</NDCCode><ProprietaryName>Maxitrol</ProprietaryName><NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>82667-200-05</NDCCode><ProprietaryName>Iopidine 1%</ProprietaryName><NonProprietaryName>Apraclonidine Hydrochloride Ophthalmic Solution</NonProprietaryName></NDC><NDC><NDCCode>82667-300-05</NDCCode><ProprietaryName>Iheezo</ProprietaryName><NonProprietaryName>Chloroprocaine Hydrochloride Ophthalmic Gel</NonProprietaryName></NDC><NDC><NDCCode>82667-600-05</NDCCode><ProprietaryName>Maxidex</ProprietaryName><NonProprietaryName>Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>82667-015-24</NDCCode><ProprietaryName>Zerviate</ProprietaryName><NonProprietaryName>Cetirizine</NonProprietaryName></NDC><NDC><NDCCode>82667-200-01</NDCCode><ProprietaryName>Iopidine 1%</ProprietaryName><NonProprietaryName>Apraclonidine Hydrochloride Ophthalmic Solution</NonProprietaryName></NDC><NDC><NDCCode>10402-021-05</NDCCode><NonProprietaryName>Cephalothin Sodium</NonProprietaryName></NDC><NDC><NDCCode>11084-021-05</NDCCode><ProprietaryName>Antibacterial Foam</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>11086-021-05</NDCCode><ProprietaryName>Triple</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>11086-021-15</NDCCode><ProprietaryName>Triple</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>13107-021-05</NDCCode><ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>13668-021-05</NDCCode><ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName><NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16714-021-05</NDCCode><ProprietaryName>Propranolol Hydrochloride</ProprietaryName><NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16864-021-05</NDCCode><ProprietaryName>Triple Diaper Rash</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>23155-021-05</NDCCode><ProprietaryName>Ketoprofen</ProprietaryName><NonProprietaryName>Ketoprofen</NonProprietaryName></NDC><NDC><NDCCode>25225-021-05</NDCCode><ProprietaryName>Sunkissed Honeydew Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>31722-021-05</NDCCode><ProprietaryName>Divalproex Sodium</ProprietaryName><NonProprietaryName>Divalproex Sodium</NonProprietaryName></NDC><NDC><NDCCode>42806-021-05</NDCCode><ProprietaryName>Citalopram</ProprietaryName><NonProprietaryName>Citalopram</NonProprietaryName></NDC><NDC><NDCCode>44397-021-05</NDCCode><ProprietaryName>Nitrous Oxide</ProprietaryName><NonProprietaryName>Nitrous Oxide</NonProprietaryName></NDC><NDC><NDCCode>45861-021-05</NDCCode><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>49643-021-05</NDCCode><ProprietaryName>Sisal</ProprietaryName><NonProprietaryName>Sisal</NonProprietaryName></NDC><NDC><NDCCode>49781-021-05</NDCCode><ProprietaryName>Leader Childrens Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>50383-021-05</NDCCode><ProprietaryName>Timolol Maleate</ProprietaryName><NonProprietaryName>Timolol Maleate</NonProprietaryName></NDC><NDC><NDCCode>52119-021-05</NDCCode><NonProprietaryName>Melatonin</NonProprietaryName></NDC><NDC><NDCCode>53746-021-05</NDCCode><ProprietaryName>Escitalopram Oxalate</ProprietaryName><NonProprietaryName>Escitalopram Oxalate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
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      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
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}
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