{
"NDC": [
{
"NDCCode": "24208-830-60",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-830-60) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0830-60",
"ProductNDC": "24208-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin Polymyxin B Sulfates And Dexamethasone",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19950913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064135",
"LabelerName": "Bausch & Lomb Incorporated",
"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": "2024-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950913",
"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, Haemophilus influenzae, Klebsiella/Enterobacterspecies, Neisseriaspecies, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescensand streptococci, including Streptococcus pneumoniae.",
"Description": "Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension, USP is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. 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. The structural formula for polymyxin B sulfate is. Each mL contains:Actives:neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives:hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative)."
},
{
"NDCCode": "24208-580-60",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-580-60) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0580-60",
"ProductNDC": "24208-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin Sulfate",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19940511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064048",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19940511",
"SamplePackage": "N",
"IndicationAndUsage": "Gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms. Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa,and Serratia marcescens.",
"Description": "Gentamicin sulfate ophthalmic solution, USP is a sterile, aqueous solution buffered to approximately pH 7.0 and formulated for ophthalmic use. Each mL contains. Active:gentamicin sulfate, USP (equivalent to 3 mg gentamicin). Inactives:dibasic sodium phosphate, sodium chloride, monobasic sodium phosphate, purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (6.5 - 7.5). Preservative:benzalkonium chloride 0.01%. Gentamicin is an aminoglycoside antibiotic obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, C1a and C2a. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows."
},
{
"NDCCode": "24208-615-77",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (24208-615-77) > 60 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "24208-0615-77",
"ProductNDC": "24208-615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetic Acid",
"NonProprietaryName": "Acetic Acid",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "19940225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040063",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "ACETIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "24208-750-60",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-750-60) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0750-60",
"ProductNDC": "24208-750",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19900930",
"EndMarketingDate": "20160930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "24208-800-60",
"PackageDescription": "60 BLISTER PACK in 1 CARTON (24208-800-60) / 1 INSERT in 1 BLISTER PACK",
"NDC11Code": "24208-0800-60",
"ProductNDC": "24208-800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacrisert",
"NonProprietaryName": "Hydroxypropyl Cellulose",
"DosageFormName": "INSERT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19810601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018771",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "HYDROXYPROPYL CELLULOSE (1600000 WAMW)",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Demulcent Activity [MoA], Demulcent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19810601",
"SamplePackage": "N",
"IndicationAndUsage": "LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. LACRISERT is also indicated for patients with: 1 Exposure keratitisDecreased corneal sensitivityRecurrent corneal erosions.",
"Description": "LACRISERT® (hydroxypropyl cellulose ophthalmic insert) is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye. The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CH2CHOHCH3) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is. The molecular weight is typically 1 × 106. Hydroxypropyl cellulose is an off-white, odorless, tasteless powder. It is soluble in water below 38°C, and in many polar organic solvents such as ethanol, propylene glycol, dioxane, methanol, isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide. Each LACRISERT is 5 mg of hydroxypropyl cellulose. LACRISERT contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long. LACRISERT is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing LACRISERT from the unit dose blister and inserting it into the eye. A spare applicator is included in each package."
},
{
"NDCCode": "24208-960-67",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-960-67) > 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0960-67",
"ProductNDC": "24208-960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19940228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064042",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-12-19"
},
{
"NDCCode": "16590-830-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16590-830-60)",
"NDC11Code": "16590-0830-60",
"ProductNDC": "16590-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072099",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Desipramine hydrochloride is indicated for the treatment of depression.",
"Description": "Desipramine hydrochloride USP is an antidepressant drug of the tricyclic type available as tablets of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg for oral administration. Its chemical name is 5H-Dibenz[bf]azepine-5-propanamine, 10, 11-dihydro-N-methyl-, monohydrochloride. Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), and titanium dioxide."
},
{
"NDCCode": "21695-830-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (21695-830-60)",
"NDC11Code": "21695-0830-60",
"ProductNDC": "21695-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fexmid",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071611",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fexmid is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms: namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Fexmid should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "30142-830-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (30142-830-60) > 60 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "30142-0830-60",
"ProductNDC": "30142-830",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna S",
"NonProprietaryName": "Docusate Sodium, Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190131",
"EndMarketingDate": "20250530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "The Kroger Co.",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190131",
"EndMarketingDatePackage": "20250530",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in 6-12 hours."
},
{
"NDCCode": "35356-830-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (35356-830-60)",
"NDC11Code": "35356-0830-60",
"ProductNDC": "35356-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090659",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "41520-830-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (41520-830-60) > 60 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "41520-0830-60",
"ProductNDC": "41520-830",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna S Orange",
"NonProprietaryName": "Docusate Sodium Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190228",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Care One (American Sales Company)",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190228",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "45865-830-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (45865-830-60) ",
"NDC11Code": "45865-0830-60",
"ProductNDC": "45865-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091103",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150727",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C 17H 17ClN 6O 3. Eszopiclone has a single chiral center with an ( S)-configuration. It has the following chemical structure:. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg)."
},
{
"NDCCode": "55700-830-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (55700-830-60) ",
"NDC11Code": "55700-0830-60",
"ProductNDC": "55700-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074569",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191211",
"SamplePackage": "N",
"IndicationAndUsage": "Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).",
"Description": "Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula. C15H10ClN3O3 M.W. 315.72."
},
{
"NDCCode": "58411-830-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-830-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0830-60",
"ProductNDC": "58411-830",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum Spf 25 Sunscreen 3n1 Sand",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Mercier Cosmetics",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.53; 2.55; 2.55; 1.53",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "61919-830-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (61919-830-60) ",
"NDC11Code": "61919-0830-60",
"ProductNDC": "61919-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levertiracetam",
"NonProprietaryName": "Levertiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078993",
"LabelerName": "Direct_Rx",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190603",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Partial Onset Seizures. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. [Chemical Structure]. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red. Meets USP dissolution test 2."
},
{
"NDCCode": "63187-830-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (63187-830-60) ",
"NDC11Code": "63187-0830-60",
"ProductNDC": "63187-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091497",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2022-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170403",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.",
"Description": "Losartan potassium is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium tablets, USP, 25 mg, 50 mg and 100 mg, contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Losartan potassium tablets USP, 25 mg and 50 mg meet USP Dissolution Test 1 and Losartan potassium tablets USP, 100 mg meet USP dissolution Test 3."
},
{
"NDCCode": "66721-830-60",
"PackageDescription": "20 kg in 1 DRUM (66721-830-60) ",
"NDC11Code": "66721-0830-60",
"ProductNDC": "66721-830",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lenacapavir",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220817",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Yuhan Chemical Inc",
"SubstanceName": "LENACAPAVIR",
"StrengthNumber": "20",
"StrengthUnit": "kg/20kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "17-AUG-22"
},
{
"NDCCode": "71205-830-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-830-60) ",
"NDC11Code": "71205-0830-60",
"ProductNDC": "71205-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19860723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089424",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3). , 4 Treatment of primary hyperaldosternism for: (1.4).oShort-term preoperative treatment oLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Spironolactone tablets, 25 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, docusate sodium 85%/sodium benzoate 15%, entrapped peppermint flavor, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Spironolactone tablets, 50 mg and 100 mg contain the following inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, docusate sodium 85%/sodium benzoate 15%, entrapped peppermint flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "71610-830-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-830-60) ",
"NDC11Code": "71610-0830-60",
"ProductNDC": "71610-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"ProprietaryNameSuffix": "10 Mg",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078414",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241219",
"SamplePackage": "N",
"Description": "Amlodipine besylate tablets are the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "76420-830-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76420-830-60) ",
"NDC11Code": "76420-0830-60",
"ProductNDC": "76420-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208170",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240702",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
},
{
"NDCCode": "80725-830-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (80725-830-60) ",
"NDC11Code": "80725-0830-60",
"ProductNDC": "80725-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Droxia",
"NonProprietaryName": "Hydroxyurea",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250911",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016295",
"LabelerName": "Waylis Therapeutics LLC",
"SubstanceName": "HYDROXYUREA",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite [EPC], Urea [CS]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250911",
"SamplePackage": "N",
"IndicationAndUsage": "DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises.",
"Description": "DROXIA® (hydroxyurea capsules, USP) is available for oral use as capsules containing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients include citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules). Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH4N2O2 and it has a molecular weight of 76.05. Its structural formula is."
},
{
"NDCCode": "24208-800-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (24208-800-10) / 1 INSERT in 1 BLISTER PACK",
"NDC11Code": "24208-0800-10",
"ProductNDC": "24208-800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacrisert",
"NonProprietaryName": "Hydroxypropyl Cellulose",
"DosageFormName": "INSERT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19810601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018771",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "HYDROXYPROPYL CELLULOSE (1600000 WAMW)",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Demulcent Activity [MoA], Demulcent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19810601",
"SamplePackage": "N",
"IndicationAndUsage": "LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. LACRISERT is also indicated for patients with: 1 Exposure keratitisDecreased corneal sensitivityRecurrent corneal erosions.",
"Description": "LACRISERT® (hydroxypropyl cellulose ophthalmic insert) is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye. The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CH2CHOHCH3) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is. The molecular weight is typically 1 × 106. Hydroxypropyl cellulose is an off-white, odorless, tasteless powder. It is soluble in water below 38°C, and in many polar organic solvents such as ethanol, propylene glycol, dioxane, methanol, isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide. Each LACRISERT is 5 mg of hydroxypropyl cellulose. LACRISERT contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long. LACRISERT is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing LACRISERT from the unit dose blister and inserting it into the eye. A spare applicator is included in each package."
},
{
"NDCCode": "59651-973-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59651-973-60) ",
"NDC11Code": "59651-0973-60",
"ProductNDC": "59651-973",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208039",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "59651-974-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59651-974-60) ",
"NDC11Code": "59651-0974-60",
"ProductNDC": "59651-974",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208039",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "59651-975-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59651-975-60) ",
"NDC11Code": "59651-0975-60",
"ProductNDC": "59651-975",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208039",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "24208-001-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (24208-001-04) / 113 g in 1 BOTTLE",
"NDC11Code": "24208-0001-04",
"ProductNDC": "24208-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purpose",
"NonProprietaryName": "Octinoxate, Octisalate And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131007",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "7.5; 5; 3",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131007",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps prevent sunburn."
},
{
"NDCCode": "24208-002-01",
"PackageDescription": "6 VIAL, SINGLE-USE in 1 CARTON (24208-002-01) > 1.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "24208-0002-01",
"ProductNDC": "24208-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrase",
"NonProprietaryName": "Hyaluronidase, Ovine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20050201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021640",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "HYALURONIDASE, OVINE",
"StrengthNumber": "200",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "24208-002-02",
"PackageDescription": "2 VIAL, SINGLE-USE in 1 CARTON (24208-002-02) / 1.2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "24208-0002-02",
"ProductNDC": "24208-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitrase",
"NonProprietaryName": "Hyaluronidase, Ovine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20050201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021640",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "HYALURONIDASE (OVINE)",
"StrengthNumber": "200",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050201",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "VITRASE is an endoglycosidase indicated as an adjuvant: 1 in subcutaneous fluid administration for achieving hydration. ( 1.1) , 2 for increasing the dispersion and absorption of other injected drugs. ( 1.2) , 3 for improving resorption of radiopaque agents, in subcutaneous urography. ( 1.3) .",
"Description": "Hyaluronidase is an endoglycosidase. VITRASE is a preparation of purified ovine testicular hyaluronidase, a protein enzyme. Hyaluronidase is composed of two major glycosylated forms, α and β. The exact chemical structure of this enzyme is unknown. VITRASE (hyaluronidase injection) is supplied as a sterile, non-preserved, clear and colorless 1 mL solution in a single-dose vial for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, for retrobulbar use, for soft tissue use, or for subcutaneous use. Each mL contains 200 USP units of hyaluronidase with dibasic potassium phosphate (0.36 mg), lactose monohydrate (0.93 mg), monobasic potassium phosphate (0.23 mg), and sodium chloride (9 mg). The solution has a pH of 6.4 to 7.2."
},
{
"NDCCode": "24208-004-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0004-01",
"ProductNDC": "24208-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Istalol",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20040802",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021516",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040802",
"SamplePackage": "N",
"IndicationAndUsage": "ISTALOL ®is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "ISTALOL (timolol maleate ophthalmic solution) 0.5% is a non-selective beta-adrenergic receptor blocking agent for topical ophthalmic use. Its chemical name is (-)-1-( tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. Its molecular formula is C 13H 24N 4O 3S-C 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. ISTALOL is stable at room temperature. ISTALOL ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in a single strength. It has a pH of 6.5-7.5 and an osmolality of 275-330 mOsm/kg. Each mL of ISTALOL contains the active ingredient 5 mg of timolol (6.8 mg of timolol maleate) with the inactive ingredients benzalkonium chloride (0.05 mg/mL), monobasic sodium phosphate monohydrate, potassium sorbate 0.47%, sodium chloride, sodium hydroxide, and purified water."
},
{
"NDCCode": "24208-004-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0004-02",
"ProductNDC": "24208-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Istalol",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20040802",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021516",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040802",
"SamplePackage": "N",
"IndicationAndUsage": "ISTALOL ®is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "ISTALOL (timolol maleate ophthalmic solution) 0.5% is a non-selective beta-adrenergic receptor blocking agent for topical ophthalmic use. Its chemical name is (-)-1-( tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. Its molecular formula is C 13H 24N 4O 3S-C 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. ISTALOL is stable at room temperature. ISTALOL ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in a single strength. It has a pH of 6.5-7.5 and an osmolality of 275-330 mOsm/kg. Each mL of ISTALOL contains the active ingredient 5 mg of timolol (6.8 mg of timolol maleate) with the inactive ingredients benzalkonium chloride (0.05 mg/mL), monobasic sodium phosphate monohydrate, potassium sorbate 0.47%, sodium chloride, sodium hydroxide, and purified water."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>24208-830-60</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-830-60) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0830-60</NDC11Code>
<ProductNDC>24208-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin Polymyxin B Sulfates And Dexamethasone</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19950913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064135</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</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>2024-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950913</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, Haemophilus influenzae, Klebsiella/Enterobacterspecies, Neisseriaspecies, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescensand streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension, USP is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. 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. The structural formula for polymyxin B sulfate is. Each mL contains:Actives:neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives:hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative).</Description>
</NDC>
<NDC>
<NDCCode>24208-580-60</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-580-60) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0580-60</NDC11Code>
<ProductNDC>24208-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin Sulfate</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19940511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064048</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms. Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa,and Serratia marcescens.</IndicationAndUsage>
<Description>Gentamicin sulfate ophthalmic solution, USP is a sterile, aqueous solution buffered to approximately pH 7.0 and formulated for ophthalmic use. Each mL contains. Active:gentamicin sulfate, USP (equivalent to 3 mg gentamicin). Inactives:dibasic sodium phosphate, sodium chloride, monobasic sodium phosphate, purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (6.5 - 7.5). Preservative:benzalkonium chloride 0.01%. Gentamicin is an aminoglycoside antibiotic obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, C1a and C2a. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>24208-615-77</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (24208-615-77) > 60 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>24208-0615-77</NDC11Code>
<ProductNDC>24208-615</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetic Acid</ProprietaryName>
<NonProprietaryName>Acetic Acid</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>19940225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040063</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>ACETIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>24208-750-60</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-750-60) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0750-60</NDC11Code>
<ProductNDC>24208-750</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<EndMarketingDate>20160930</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>24208-800-60</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 CARTON (24208-800-60) / 1 INSERT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>24208-0800-60</NDC11Code>
<ProductNDC>24208-800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacrisert</ProprietaryName>
<NonProprietaryName>Hydroxypropyl Cellulose</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19810601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018771</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>HYDROXYPROPYL CELLULOSE (1600000 WAMW)</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Demulcent Activity [MoA], Demulcent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. LACRISERT is also indicated for patients with: 1 Exposure keratitisDecreased corneal sensitivityRecurrent corneal erosions.</IndicationAndUsage>
<Description>LACRISERT® (hydroxypropyl cellulose ophthalmic insert) is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye. The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CH2CHOHCH3) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is. The molecular weight is typically 1 × 106. Hydroxypropyl cellulose is an off-white, odorless, tasteless powder. It is soluble in water below 38°C, and in many polar organic solvents such as ethanol, propylene glycol, dioxane, methanol, isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide. Each LACRISERT is 5 mg of hydroxypropyl cellulose. LACRISERT contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long. LACRISERT is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing LACRISERT from the unit dose blister and inserting it into the eye. A spare applicator is included in each package.</Description>
</NDC>
<NDC>
<NDCCode>24208-960-67</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-960-67) > 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0960-67</NDC11Code>
<ProductNDC>24208-960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064042</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>16590-830-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16590-830-60)</PackageDescription>
<NDC11Code>16590-0830-60</NDC11Code>
<ProductNDC>16590-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072099</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Desipramine hydrochloride is indicated for the treatment of depression.</IndicationAndUsage>
<Description>Desipramine hydrochloride USP is an antidepressant drug of the tricyclic type available as tablets of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg for oral administration. Its chemical name is 5H-Dibenz[bf]azepine-5-propanamine, 10, 11-dihydro-N-methyl-, monohydrochloride. Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-830-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (21695-830-60)</PackageDescription>
<NDC11Code>21695-0830-60</NDC11Code>
<ProductNDC>21695-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fexmid</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071611</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fexmid is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms: namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Fexmid should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>30142-830-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (30142-830-60) > 60 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>30142-0830-60</NDC11Code>
<ProductNDC>30142-830</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna S</ProprietaryName>
<NonProprietaryName>Docusate Sodium, Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190131</StartMarketingDate>
<EndMarketingDate>20250530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>The Kroger Co.</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190131</StartMarketingDatePackage>
<EndMarketingDatePackage>20250530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in 6-12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35356-830-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (35356-830-60)</PackageDescription>
<NDC11Code>35356-0830-60</NDC11Code>
<ProductNDC>35356-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090659</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41520-830-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (41520-830-60) > 60 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>41520-0830-60</NDC11Code>
<ProductNDC>41520-830</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna S Orange</ProprietaryName>
<NonProprietaryName>Docusate Sodium Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190228</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Care One (American Sales Company)</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190228</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45865-830-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (45865-830-60) </PackageDescription>
<NDC11Code>45865-0830-60</NDC11Code>
<ProductNDC>45865-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091103</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C 17H 17ClN 6O 3. Eszopiclone has a single chiral center with an ( S)-configuration. It has the following chemical structure:. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg).</Description>
</NDC>
<NDC>
<NDCCode>55700-830-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (55700-830-60) </PackageDescription>
<NDC11Code>55700-0830-60</NDC11Code>
<ProductNDC>55700-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074569</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula. C15H10ClN3O3 M.W. 315.72.</Description>
</NDC>
<NDC>
<NDCCode>58411-830-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-830-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0830-60</NDC11Code>
<ProductNDC>58411-830</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum Spf 25 Sunscreen 3n1 Sand</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laura Mercier Cosmetics</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.53; 2.55; 2.55; 1.53</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61919-830-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (61919-830-60) </PackageDescription>
<NDC11Code>61919-0830-60</NDC11Code>
<ProductNDC>61919-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levertiracetam</ProprietaryName>
<NonProprietaryName>Levertiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078993</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Partial Onset Seizures. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. [Chemical Structure]. Levetiracetam USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red. Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>63187-830-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (63187-830-60) </PackageDescription>
<NDC11Code>63187-0830-60</NDC11Code>
<ProductNDC>63187-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091497</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium tablets, USP, 25 mg, 50 mg and 100 mg, contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Losartan potassium tablets USP, 25 mg and 50 mg meet USP Dissolution Test 1 and Losartan potassium tablets USP, 100 mg meet USP dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>66721-830-60</NDCCode>
<PackageDescription>20 kg in 1 DRUM (66721-830-60) </PackageDescription>
<NDC11Code>66721-0830-60</NDC11Code>
<ProductNDC>66721-830</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lenacapavir</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220817</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Yuhan Chemical Inc</LabelerName>
<SubstanceName>LENACAPAVIR</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>kg/20kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-AUG-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71205-830-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-830-60) </PackageDescription>
<NDC11Code>71205-0830-60</NDC11Code>
<ProductNDC>71205-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089424</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3). , 4 Treatment of primary hyperaldosternism for: (1.4).oShort-term preoperative treatment oLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .</IndicationAndUsage>
<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Spironolactone tablets, 25 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, docusate sodium 85%/sodium benzoate 15%, entrapped peppermint flavor, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Spironolactone tablets, 50 mg and 100 mg contain the following inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, docusate sodium 85%/sodium benzoate 15%, entrapped peppermint flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71610-830-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-830-60) </PackageDescription>
<NDC11Code>71610-0830-60</NDC11Code>
<ProductNDC>71610-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<ProprietaryNameSuffix>10 Mg</ProprietaryNameSuffix>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078414</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Amlodipine besylate tablets are the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its structural formula is:. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>76420-830-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76420-830-60) </PackageDescription>
<NDC11Code>76420-0830-60</NDC11Code>
<ProductNDC>76420-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208170</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>80725-830-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (80725-830-60) </PackageDescription>
<NDC11Code>80725-0830-60</NDC11Code>
<ProductNDC>80725-830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Droxia</ProprietaryName>
<NonProprietaryName>Hydroxyurea</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250911</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016295</ApplicationNumber>
<LabelerName>Waylis Therapeutics LLC</LabelerName>
<SubstanceName>HYDROXYUREA</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite [EPC], Urea [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises.</IndicationAndUsage>
<Description>DROXIA® (hydroxyurea capsules, USP) is available for oral use as capsules containing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients include citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules). Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH4N2O2 and it has a molecular weight of 76.05. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>24208-800-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (24208-800-10) / 1 INSERT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>24208-0800-10</NDC11Code>
<ProductNDC>24208-800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacrisert</ProprietaryName>
<NonProprietaryName>Hydroxypropyl Cellulose</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19810601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018771</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>HYDROXYPROPYL CELLULOSE (1600000 WAMW)</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Demulcent Activity [MoA], Demulcent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. LACRISERT is also indicated for patients with: 1 Exposure keratitisDecreased corneal sensitivityRecurrent corneal erosions.</IndicationAndUsage>
<Description>LACRISERT® (hydroxypropyl cellulose ophthalmic insert) is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye. The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CH2CHOHCH3) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is. The molecular weight is typically 1 × 106. Hydroxypropyl cellulose is an off-white, odorless, tasteless powder. It is soluble in water below 38°C, and in many polar organic solvents such as ethanol, propylene glycol, dioxane, methanol, isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide. Each LACRISERT is 5 mg of hydroxypropyl cellulose. LACRISERT contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long. LACRISERT is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing LACRISERT from the unit dose blister and inserting it into the eye. A spare applicator is included in each package.</Description>
</NDC>
<NDC>
<NDCCode>59651-973-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59651-973-60) </PackageDescription>
<NDC11Code>59651-0973-60</NDC11Code>
<ProductNDC>59651-973</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208039</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>59651-974-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59651-974-60) </PackageDescription>
<NDC11Code>59651-0974-60</NDC11Code>
<ProductNDC>59651-974</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208039</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>59651-975-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59651-975-60) </PackageDescription>
<NDC11Code>59651-0975-60</NDC11Code>
<ProductNDC>59651-975</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208039</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>24208-001-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24208-001-04) / 113 g in 1 BOTTLE</PackageDescription>
<NDC11Code>24208-0001-04</NDC11Code>
<ProductNDC>24208-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purpose</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131007</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>7.5; 5; 3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24208-002-01</NDCCode>
<PackageDescription>6 VIAL, SINGLE-USE in 1 CARTON (24208-002-01) > 1.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>24208-0002-01</NDC11Code>
<ProductNDC>24208-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrase</ProprietaryName>
<NonProprietaryName>Hyaluronidase, Ovine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021640</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>HYALURONIDASE, OVINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>24208-002-02</NDCCode>
<PackageDescription>2 VIAL, SINGLE-USE in 1 CARTON (24208-002-02) / 1.2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>24208-0002-02</NDC11Code>
<ProductNDC>24208-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitrase</ProprietaryName>
<NonProprietaryName>Hyaluronidase, Ovine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021640</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>HYALURONIDASE (OVINE)</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050201</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VITRASE is an endoglycosidase indicated as an adjuvant: 1 in subcutaneous fluid administration for achieving hydration. ( 1.1) , 2 for increasing the dispersion and absorption of other injected drugs. ( 1.2) , 3 for improving resorption of radiopaque agents, in subcutaneous urography. ( 1.3) .</IndicationAndUsage>
<Description>Hyaluronidase is an endoglycosidase. VITRASE is a preparation of purified ovine testicular hyaluronidase, a protein enzyme. Hyaluronidase is composed of two major glycosylated forms, α and β. The exact chemical structure of this enzyme is unknown. VITRASE (hyaluronidase injection) is supplied as a sterile, non-preserved, clear and colorless 1 mL solution in a single-dose vial for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, for retrobulbar use, for soft tissue use, or for subcutaneous use. Each mL contains 200 USP units of hyaluronidase with dibasic potassium phosphate (0.36 mg), lactose monohydrate (0.93 mg), monobasic potassium phosphate (0.23 mg), and sodium chloride (9 mg). The solution has a pH of 6.4 to 7.2.</Description>
</NDC>
<NDC>
<NDCCode>24208-004-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0004-01</NDC11Code>
<ProductNDC>24208-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Istalol</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20040802</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021516</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</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>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ISTALOL ®is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>ISTALOL (timolol maleate ophthalmic solution) 0.5% is a non-selective beta-adrenergic receptor blocking agent for topical ophthalmic use. Its chemical name is (-)-1-( tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. Its molecular formula is C 13H 24N 4O 3S-C 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. ISTALOL is stable at room temperature. ISTALOL ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in a single strength. It has a pH of 6.5-7.5 and an osmolality of 275-330 mOsm/kg. Each mL of ISTALOL contains the active ingredient 5 mg of timolol (6.8 mg of timolol maleate) with the inactive ingredients benzalkonium chloride (0.05 mg/mL), monobasic sodium phosphate monohydrate, potassium sorbate 0.47%, sodium chloride, sodium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>24208-004-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0004-02</NDC11Code>
<ProductNDC>24208-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Istalol</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20040802</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021516</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</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>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ISTALOL ®is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>ISTALOL (timolol maleate ophthalmic solution) 0.5% is a non-selective beta-adrenergic receptor blocking agent for topical ophthalmic use. Its chemical name is (-)-1-( tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. Its molecular formula is C 13H 24N 4O 3S-C 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. ISTALOL is stable at room temperature. ISTALOL ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in a single strength. It has a pH of 6.5-7.5 and an osmolality of 275-330 mOsm/kg. Each mL of ISTALOL contains the active ingredient 5 mg of timolol (6.8 mg of timolol maleate) with the inactive ingredients benzalkonium chloride (0.05 mg/mL), monobasic sodium phosphate monohydrate, potassium sorbate 0.47%, sodium chloride, sodium hydroxide, and purified water.</Description>
</NDC>
</NDCList>