{
"NDC": [
{
"NDCCode": "82260-496-05",
"PackageDescription": "6 POUCH in 1 CARTON (82260-496-05) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER",
"NDC11Code": "82260-0496-05",
"ProductNDC": "82260-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220217",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019463",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "6.8",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220217",
"SamplePackage": "N",
"IndicationAndUsage": "Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE may be used when a patient is sensitive to the preservative in Timolol Maleate Ophthalmic Solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.",
"Description": "Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. Its molecular formula is C 13H 24N 4O 3SC 4H 4O 4, and 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; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: Timolol Maleate Ophthalmic Solution, which contains the preservative benzalkonium chloride; and Timolol Maleate Ophthalmic Solution, the preservative-free formulation. Preservative-free Timolol Maleate Ophthalmic Solution is supplied in OCUDOSE ®, a unit dose container, as a sterile, isotonic, buffered, aqueous solution of timolol maleate. Each mL of Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE ®0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection."
},
{
"NDCCode": "24208-496-05",
"PackageDescription": "4 POUCH in 1 CARTON (24208-496-05) > 15 CONTAINER in 1 POUCH > .3 mL in 1 CONTAINER",
"NDC11Code": "24208-0496-05",
"ProductNDC": "24208-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20210316",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019463",
"LabelerName": "BAUSCH & LOMB INCORPORATED",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "6.8",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210316",
"SamplePackage": "N",
"IndicationAndUsage": "Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE may be used when a patient is sensitive to the preservative in Timolol Maleate Ophthalmic Solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.",
"Description": "Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4, and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: Timolol Maleate Ophthalmic Solution, which contains the preservative benzalkonium chloride; and Timolol Maleate Ophthalmic Solution, the preservative-free formulation. Preservative-free Timolol Maleate Ophthalmic Solution is supplied in OCUDOSE®, a unit dose container, as a sterile, isotonic, buffered, aqueous solution of timolol maleate. Each mL of Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE® 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection."
},
{
"NDCCode": "50228-496-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-496-05) ",
"NDC11Code": "50228-0496-05",
"ProductNDC": "50228-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216327",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230406",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Tablet is a nondihydropyridine calcium channel blocker indicated for: 1 treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1) , 2 improving exercise tolerance in patients with chronic stable angina. ( 1.2) .",
"Description": "Diltiazem hydrochloride is a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2¬ (dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is. Diltiazem hydrochloride is a white, odorless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water, sparingly soluble in dehydrated alcohol, insoluble in ether. It has a molecular weight of 450.99. Diltiazem hydrochloride extended-release tablets are formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: colloidal silicon dioxide, ethyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide and triethyl citrate."
},
{
"NDCCode": "55111-496-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-496-05) ",
"NDC11Code": "55111-0496-05",
"ProductNDC": "55111-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204345",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201210",
"SamplePackage": "N",
"Description": "Capecitabine, USP is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine, USP has the following structural formula. Capecitabine, USP is a white to off-white crystalline powder. Freely soluble in methanol, soluble in acetonitrile and in ethanol. Sparingly soluble in water. Capecitabine tablets, USP are supplied as biconvex, oblong film-coated tablets for oral use. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in capecitabine tablets, USP include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides."
},
{
"NDCCode": "68001-496-05",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-496-05) ",
"NDC11Code": "68001-0496-05",
"ProductNDC": "68001-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214419",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210430",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).",
"Description": "Venlafaxine extended-release tablets (venlafaxine hydrochloride) are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a off-white to white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended-release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine extended-release tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of venlafaxine extended-release tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. Tablets contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of mannitol, microcrystalline cellulose, povidone, polyethylene glycol, colloidal silicon dioxide, magnesium stearate, cellulose acetate, hypromellose, titanium dioxide and talc. Each tablet strength also contains black iron oxide, hypromellose and propylene glycol as imprinting ink."
},
{
"NDCCode": "68428-496-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-496-05) ",
"NDC11Code": "68428-0496-05",
"ProductNDC": "68428-496",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Melilotus Alba",
"NonProprietaryName": "Melilotus Officinalis Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MELILOTUS OFFICINALIS TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "84522-496-05",
"PackageDescription": "100 g in 1 BOX (84522-496-05) ",
"NDC11Code": "84522-0496-05",
"ProductNDC": "84522-496",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Dark Spot Corrector Cream",
"NonProprietaryName": "Trstay Dark Spot Corrector Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-496-05",
"PackageDescription": "100 g in 1 BOX (84756-496-05) ",
"NDC11Code": "84756-0496-05",
"ProductNDC": "84756-496",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Dark Spot Corrector Cream",
"NonProprietaryName": "Trstay Dark Spot Corrector Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241127",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E �Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241127",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "82260-045-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-045-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0045-05",
"ProductNDC": "82260-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021516",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220623",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "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. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate 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 Timolol Maleate Ophthalmic Solution 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": "82260-103-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-103-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0103-05",
"ProductNDC": "82260-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20230331",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA203510",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is a sterile, clear, colorless, topical mydriatic agent for ophthalmic use. The chemical name is (R)-3-hydroxy-α-[(methylamino)methyl]benzenemethanol hydrochloride. Phenylephrine hydrochloride is represented by the following structural formula. Phenylephrine hydrochloride has a molecular weight of 203.67 and an empirical formula of C9H13NO2-HCl. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% contains: ACTIVE: phenylephrine hydrochloride 25 mg (2.5%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; boric acid, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.5). The solution has a tonicity of 500 mOsm/kg; PRESERVATIVE: benzalkonium chloride 0.01%. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: phenylephrine hydrochloride 100 mg (10%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.5). The solution has a tonicity of 1000 mOsm/kg; PRESERVATIVE: benzalkonium chloride 0.01%."
},
{
"NDCCode": "82260-299-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (82260-299-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "82260-0299-05",
"ProductNDC": "82260-299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20230407",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020583",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230407",
"SamplePackage": "N",
"IndicationAndUsage": "Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.",
"Description": "Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. Active: Loteprednol Etabonate 5 mg (0.5%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. Preservative: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "82260-358-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-358-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0358-05",
"ProductNDC": "82260-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate And Tobramycin",
"NonProprietaryName": "Loteprednol Etabonate And Tobramycin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260109",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050804",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "LOTEPREDNOL ETABONATE; TOBRAMYCIN",
"StrengthNumber": "5; 3",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260109",
"SamplePackage": "N",
"IndicationAndUsage": "Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens. Staphylococci, including S. aureusand S. epidermidis(coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgarisstrains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticusand some Neisseriaspecies.",
"Description": "Loteprednol Etabonate and Tobramycin Ophthalmic Suspension is a sterile, multiple dose topical anti-inflammatory corticosteroid and anti-infective combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below. Loteprednol etabonate. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11 β-hydroxy-3-oxoandrosta-1,4-diene-17 β-carboxylate. Tobramycin. Chemical name. O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxystreptamine. Each mL contains: Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5 to 6.2. The suspension is essentially isotonic with a tonicity of 260 to 320 mOsm/kg."
},
{
"NDCCode": "82260-361-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-361-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0361-05",
"ProductNDC": "82260-361",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loteprednol Etabonate",
"NonProprietaryName": "Loteprednol Etabonate",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240209",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020803",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "LOTEPREDNOL ETABONATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240209",
"SamplePackage": "N",
"IndicationAndUsage": "Loteprednol Etabonate Ophthalmic Suspension, 0.2% is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.",
"Description": "Loteprednol Etabonate Ophthalmic Suspension, 0.2% contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "82260-446-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-446-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0446-05",
"ProductNDC": "82260-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besivance",
"NonProprietaryName": "Besifloxacin",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022308",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "BESIFLOXACIN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260109",
"SamplePackage": "N",
"IndicationAndUsage": "Besifloxacin ophthalmic suspension 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: 1 Aerococcus viridans* , 2 CDC coryneform group G, 3 Corynebacterium pseudodiphtheriticum*, 4 Corynebacterium striatum*, 5 Haemophilus influenzae, 6 Moraxella catarrhalis*, 7 Moraxella lacunata*, 8 Pseudomonas aeruginosa*, 9 Staphylococcus aureus, 10 Staphylococcus epidermidis, 11 Staphylococcus hominis*, 12 Staphylococcus lugdunensis*, 13 Staphylococcus warneri*, 14 Streptococcus mitisgroup , 15 Streptococcus oralis, 16 Streptococcus pneumoniae.",
"Description": "Besifloxacin ophthalmic suspension 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ®†(polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). Each mL of besifloxacin ophthalmic suspension contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8‑chloro fluoroquinolone anti-infective for topical ophthalmic use. Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Besifloxacin hydrochloride is a white to pale yellowish-white powder. Each mL contains. Active:besifloxacin 0.6% (6 mg/mL);. Inactives:polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative:benzalkonium chloride 0.01%. Besifloxacin ophthalmic suspension is an isotonic suspension with an osmolality of approximately 290 mOsm/kg."
},
{
"NDCCode": "82260-466-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-466-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0466-05",
"ProductNDC": "82260-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besivance",
"NonProprietaryName": "Besifloxacin",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022308",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "BESIFLOXACIN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260109",
"SamplePackage": "N",
"IndicationAndUsage": "Besifloxacin ophthalmic suspension 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: 1 Aerococcus viridans* , 2 CDC coryneform group G, 3 Corynebacterium pseudodiphtheriticum*, 4 Corynebacterium striatum*, 5 Haemophilus influenzae, 6 Moraxella catarrhalis*, 7 Moraxella lacunata*, 8 Pseudomonas aeruginosa*, 9 Staphylococcus aureus, 10 Staphylococcus epidermidis, 11 Staphylococcus hominis*, 12 Staphylococcus lugdunensis*, 13 Staphylococcus warneri*, 14 Streptococcus mitisgroup , 15 Streptococcus oralis, 16 Streptococcus pneumoniae.",
"Description": "Besifloxacin ophthalmic suspension 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ®†(polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). Each mL of besifloxacin ophthalmic suspension contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8‑chloro fluoroquinolone anti-infective for topical ophthalmic use. Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Besifloxacin hydrochloride is a white to pale yellowish-white powder. Each mL contains. Active:besifloxacin 0.6% (6 mg/mL);. Inactives:polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative:benzalkonium chloride 0.01%. Besifloxacin ophthalmic suspension is an isotonic suspension with an osmolality of approximately 290 mOsm/kg."
},
{
"NDCCode": "82260-630-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0630-05",
"ProductNDC": "82260-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bepotastine Besilate",
"NonProprietaryName": "Bepotastine Besilate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20210528",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022288",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "BEPOTASTINE BESYLATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210528",
"SamplePackage": "N",
"IndicationAndUsage": "Bepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H 1receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.",
"Description": "Bepotastine Besilate Ophthalmic Solution, 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepotastine Besilate Ophthalmic Solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is. Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine Besilate Ophthalmic Solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of Bepotastine Besilate Ophthalmic Solution, 1.5% is approximately 295 mOsm/kg. Each mL of Bepotastine Besilate Ophthalmic Solution, 1.5% contains: 1 Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine), 2 Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP, 3 Preservative: benzalkonium chloride 0.005%."
},
{
"NDCCode": "82260-734-05",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (82260-734-05) / 5 mL in 1 BOTTLE, GLASS",
"NDC11Code": "82260-0734-05",
"ProductNDC": "82260-734",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorescein Sodium And Benoxinate Hydrochloride",
"NonProprietaryName": "Fluorescein Sodium And Benoxinate Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20200320",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA211039",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE",
"StrengthNumber": "2.6; 4.4",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200320",
"SamplePackage": "N",
"IndicationAndUsage": "Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent.",
"Description": "Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a sterile solution containing a disclosing agent in combination with a short-acting ester anesthetic for topical ophthalmic use. Fluorescein sodium is represented by the following structural formula. Chemical Name: 3’,6’ Dihydroxy-3H-spiro[isobenzofuran-1,9-xanthen]-3-one disodium salt. Benoxinate hydrochloride is represented by the following structural formula. Chemical Name: 2-(Diethylamino) ethyl 4-amino-3-butoxybenzoate hydrochloride. Each mL of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution 0.3%/0.4% contains: 1 Active ingredients:fluorescein sodium 2.6 mg (0.3%) equivalent to fluorescein 2.3 mg (0.2%), benoxinate hydrochloride 4.4 mg (0.4%) equivalent to benoxinate 3.9 mg (0.4%) , 2 Preservative:chlorobutanol 12.6 mg (1.3%) , 3 Inactive ingredients:povidone, hydrochloric acid, boric acid, water for injection. Hydrochloric acid may be added to adjust pH (4.3 – 5.3). ."
},
{
"NDCCode": "82260-812-05",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 5 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "82260-0812-05",
"ProductNDC": "82260-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018086",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol Maleate Ophthalmic Solution is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. Its molecular formula is C 13H 24N 4O 3SC 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolality is 260-340 mOsm/kg. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and purified water. Benzalkonium chloride 0.01% is added as preservative."
},
{
"NDCCode": "82260-813-05",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "82260-0813-05",
"ProductNDC": "82260-813",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018086",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol Maleate Ophthalmic Solution is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. Its molecular formula is C 13H 24N 4O 3SC 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolality is 260-340 mOsm/kg. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and purified water. Benzalkonium chloride 0.01% is added as preservative."
},
{
"NDCCode": "82260-819-05",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "82260-0819-05",
"ProductNDC": "82260-819",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20180214",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020330",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180214",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Sterile Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. 25°. [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C 13H 24N 4O 3SC 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; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol Maleate Ophthalmic Gel Forming Solution forms a gel that is subsequently removed by the flow of tears."
},
{
"NDCCode": "82260-920-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-920-05) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0920-05",
"ProductNDC": "82260-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracaine Hydrochloride",
"NonProprietaryName": "Tetracaine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA210821",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "TETRACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.",
"Description": "Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a sterile, clear, colorless, topical local anesthetic for ophthalmic use only containing tetracaine hydrochloride as the active pharmaceutical ingredient. Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-, 2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C 15H 24N 2O 2● HCl and it is represented by the chemical structure:. Tetracaine hydrochloride is a fine, white, crystalline, odorless powder with a molecular weight of 300.83. Active ingredient:tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine). Preservative:chlorobutanol 0.4%. Inactive ingredients:boric acid, edetate disodium dihydrate, potassium chloride, water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH (3.7 – 6.0)."
},
{
"NDCCode": "82260-045-25",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-045-25) / 2.5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0045-25",
"ProductNDC": "82260-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021516",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220623",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "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. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate 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 Timolol Maleate Ophthalmic Solution 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": "82260-602-03",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82260-602-03) / 3 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82260-0602-03",
"ProductNDC": "82260-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bromfenac Ophthalmic Solution",
"NonProprietaryName": "Bromfenac Sodium",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240108",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA203168",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "BROMFENAC SODIUM",
"StrengthNumber": ".7",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240108",
"SamplePackage": "N",
"IndicationAndUsage": "Bromfenac Ophthalmic Solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.",
"Description": "Bromfenac Ophthalmic Solution 0.07% is a sterile, nonsteroidal anti-inflammatory drug (NSAID) for topical ophthalmic use. Each mL of Bromfenac Ophthalmic Solution contains 0.805 mg bromfenac sodium sesquihydrate (equivalent to 0.7 mg bromfenac free acid). The USAN name for bromfenac sodium sesquihydrate is bromfenac sodium. Bromfenac sodium is designated chemically as sodium [2-amino-3-(4-bromobenzoyl) phenyl] acetate sesquihydrate, with an empirical formula of C 15H 11BrNNaO 3 1½H 2O. The chemical structure for bromfenac sodium sesquihydrate is:. Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17. Bromfenac Ophthalmic Solution ophthalmic solution is supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The osmolality of Bromfenac Ophthalmic Solution is approximately 300 mOsmol/kg. Each mL of Bromfenac Ophthalmic Solution contains. Active:Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free acid 0.07%. Inactives:boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH, and water for injection, USP. Preservative:benzalkonium chloride 0.005%."
},
{
"NDCCode": "82260-813-10",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "82260-0813-10",
"ProductNDC": "82260-813",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018086",
"LabelerName": "Bausch & Lomb Americas Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol Maleate Ophthalmic Solution is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. Its molecular formula is C 13H 24N 4O 3SC 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolality is 260-340 mOsm/kg. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and purified water. Benzalkonium chloride 0.01% is added as preservative."
},
{
"NDCCode": "0009-0039-06",
"PackageDescription": "25 VIAL in 1 CARTON (0009-0039-06) / 1 mL in 1 VIAL (0009-0039-05) ",
"NDC11Code": "00009-0039-06",
"ProductNDC": "0009-0039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-medrol",
"NonProprietaryName": "Methylprednisolone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19590402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011856",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19590402",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
},
{
"NDCCode": "24236-496-20",
"PackageDescription": "100 TABLET in 1 CANISTER (24236-496-20)",
"NDC11Code": "24236-0496-20",
"ProductNDC": "24236-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trihexyphenidyl Hydrochloride",
"NonProprietaryName": "Trihexyphenidyl Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040337",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TRIHEXYPHENIDYL HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-05-01"
},
{
"NDCCode": "31722-496-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (31722-496-18) ",
"NDC11Code": "31722-0496-18",
"ProductNDC": "31722-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219332",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250520",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).",
"Description": "Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxabantablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxzolidin-5-yl}methyl)thiophene-2-carboxamide. The molecular formula of rivaroxaban is C19H18C1N3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxy propyl methyl cellulose, sodium lauryl sulfate and magnesium stearate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Aquarius Prime Yellow, containing hypromellose, D&C yellow no.10 aluminum lake, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "31722-496-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (31722-496-60) ",
"NDC11Code": "31722-0496-60",
"ProductNDC": "31722-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219332",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250520",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).",
"Description": "Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxabantablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxzolidin-5-yl}methyl)thiophene-2-carboxamide. The molecular formula of rivaroxaban is C19H18C1N3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxy propyl methyl cellulose, sodium lauryl sulfate and magnesium stearate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Aquarius Prime Yellow, containing hypromellose, D&C yellow no.10 aluminum lake, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "45802-496-14",
"PackageDescription": "1 TUBE in 1 CARTON (45802-496-14) / 15 g in 1 TUBE",
"NDC11Code": "45802-0496-14",
"ProductNDC": "45802-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077770",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150514",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "45802-496-96",
"PackageDescription": "1 TUBE in 1 CARTON (45802-496-96) / 60 g in 1 TUBE",
"NDC11Code": "45802-0496-96",
"ProductNDC": "45802-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077770",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150616",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>82260-496-05</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (82260-496-05) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>82260-0496-05</NDC11Code>
<ProductNDC>82260-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220217</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019463</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>6.8</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE may be used when a patient is sensitive to the preservative in Timolol Maleate Ophthalmic Solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.</IndicationAndUsage>
<Description>Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. Its molecular formula is C 13H 24N 4O 3SC 4H 4O 4, and 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; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: Timolol Maleate Ophthalmic Solution, which contains the preservative benzalkonium chloride; and Timolol Maleate Ophthalmic Solution, the preservative-free formulation. Preservative-free Timolol Maleate Ophthalmic Solution is supplied in OCUDOSE ®, a unit dose container, as a sterile, isotonic, buffered, aqueous solution of timolol maleate. Each mL of Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE ®0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>24208-496-05</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (24208-496-05) > 15 CONTAINER in 1 POUCH > .3 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>24208-0496-05</NDC11Code>
<ProductNDC>24208-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20210316</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019463</ApplicationNumber>
<LabelerName>BAUSCH & LOMB INCORPORATED</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>6.8</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE may be used when a patient is sensitive to the preservative in Timolol Maleate Ophthalmic Solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.</IndicationAndUsage>
<Description>Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4, and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: Timolol Maleate Ophthalmic Solution, which contains the preservative benzalkonium chloride; and Timolol Maleate Ophthalmic Solution, the preservative-free formulation. Preservative-free Timolol Maleate Ophthalmic Solution is supplied in OCUDOSE®, a unit dose container, as a sterile, isotonic, buffered, aqueous solution of timolol maleate. Each mL of Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE® 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>50228-496-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-496-05) </PackageDescription>
<NDC11Code>50228-0496-05</NDC11Code>
<ProductNDC>50228-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216327</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Tablet is a nondihydropyridine calcium channel blocker indicated for: 1 treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1) , 2 improving exercise tolerance in patients with chronic stable angina. ( 1.2) .</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2¬ (dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is. Diltiazem hydrochloride is a white, odorless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water, sparingly soluble in dehydrated alcohol, insoluble in ether. It has a molecular weight of 450.99. Diltiazem hydrochloride extended-release tablets are formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: colloidal silicon dioxide, ethyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>55111-496-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-496-05) </PackageDescription>
<NDC11Code>55111-0496-05</NDC11Code>
<ProductNDC>55111-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204345</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Capecitabine, USP is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine, USP has the following structural formula. Capecitabine, USP is a white to off-white crystalline powder. Freely soluble in methanol, soluble in acetonitrile and in ethanol. Sparingly soluble in water. Capecitabine tablets, USP are supplied as biconvex, oblong film-coated tablets for oral use. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in capecitabine tablets, USP include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.</Description>
</NDC>
<NDC>
<NDCCode>68001-496-05</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-496-05) </PackageDescription>
<NDC11Code>68001-0496-05</NDC11Code>
<ProductNDC>68001-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214419</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Venlafaxine extended-release tablets (venlafaxine hydrochloride) are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a off-white to white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended-release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine extended-release tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of venlafaxine extended-release tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. Tablets contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of mannitol, microcrystalline cellulose, povidone, polyethylene glycol, colloidal silicon dioxide, magnesium stearate, cellulose acetate, hypromellose, titanium dioxide and talc. Each tablet strength also contains black iron oxide, hypromellose and propylene glycol as imprinting ink.</Description>
</NDC>
<NDC>
<NDCCode>68428-496-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-496-05) </PackageDescription>
<NDC11Code>68428-0496-05</NDC11Code>
<ProductNDC>68428-496</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Melilotus Alba</ProprietaryName>
<NonProprietaryName>Melilotus Officinalis Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MELILOTUS OFFICINALIS TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84522-496-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84522-496-05) </PackageDescription>
<NDC11Code>84522-0496-05</NDC11Code>
<ProductNDC>84522-496</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Dark Spot Corrector Cream</ProprietaryName>
<NonProprietaryName>Trstay Dark Spot Corrector Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-496-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84756-496-05) </PackageDescription>
<NDC11Code>84756-0496-05</NDC11Code>
<ProductNDC>84756-496</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Dark Spot Corrector Cream</ProprietaryName>
<NonProprietaryName>Trstay Dark Spot Corrector Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241127</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E �Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82260-045-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-045-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0045-05</NDC11Code>
<ProductNDC>82260-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021516</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</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>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>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. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate 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 Timolol Maleate Ophthalmic Solution 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>82260-103-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-103-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0103-05</NDC11Code>
<ProductNDC>82260-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20230331</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA203510</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is a sterile, clear, colorless, topical mydriatic agent for ophthalmic use. The chemical name is (R)-3-hydroxy-α-[(methylamino)methyl]benzenemethanol hydrochloride. Phenylephrine hydrochloride is represented by the following structural formula. Phenylephrine hydrochloride has a molecular weight of 203.67 and an empirical formula of C9H13NO2-HCl. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% contains: ACTIVE: phenylephrine hydrochloride 25 mg (2.5%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; boric acid, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.5). The solution has a tonicity of 500 mOsm/kg; PRESERVATIVE: benzalkonium chloride 0.01%. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: phenylephrine hydrochloride 100 mg (10%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.5). The solution has a tonicity of 1000 mOsm/kg; PRESERVATIVE: benzalkonium chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>82260-299-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (82260-299-05) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>82260-0299-05</NDC11Code>
<ProductNDC>82260-299</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loteprednol Etabonate</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20230407</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020583</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.</IndicationAndUsage>
<Description>Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. Active: Loteprednol Etabonate 5 mg (0.5%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. Preservative: Benzalkonium Chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>82260-358-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-358-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0358-05</NDC11Code>
<ProductNDC>82260-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loteprednol Etabonate And Tobramycin</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate And Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260109</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050804</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE; TOBRAMYCIN</SubstanceName>
<StrengthNumber>5; 3</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens. Staphylococci, including S. aureusand S. epidermidis(coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgarisstrains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticusand some Neisseriaspecies.</IndicationAndUsage>
<Description>Loteprednol Etabonate and Tobramycin Ophthalmic Suspension is a sterile, multiple dose topical anti-inflammatory corticosteroid and anti-infective combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below. Loteprednol etabonate. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11 β-hydroxy-3-oxoandrosta-1,4-diene-17 β-carboxylate. Tobramycin. Chemical name. O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxystreptamine. Each mL contains: Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5 to 6.2. The suspension is essentially isotonic with a tonicity of 260 to 320 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>82260-361-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-361-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0361-05</NDC11Code>
<ProductNDC>82260-361</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loteprednol Etabonate</ProprietaryName>
<NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240209</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020803</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loteprednol Etabonate Ophthalmic Suspension, 0.2% is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.</IndicationAndUsage>
<Description>Loteprednol Etabonate Ophthalmic Suspension, 0.2% contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula. Chemical Name. chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate 2 mg (0.2%);. INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>82260-446-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-446-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0446-05</NDC11Code>
<ProductNDC>82260-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besivance</ProprietaryName>
<NonProprietaryName>Besifloxacin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022308</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>BESIFLOXACIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Besifloxacin ophthalmic suspension 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: 1 Aerococcus viridans* , 2 CDC coryneform group G, 3 Corynebacterium pseudodiphtheriticum*, 4 Corynebacterium striatum*, 5 Haemophilus influenzae, 6 Moraxella catarrhalis*, 7 Moraxella lacunata*, 8 Pseudomonas aeruginosa*, 9 Staphylococcus aureus, 10 Staphylococcus epidermidis, 11 Staphylococcus hominis*, 12 Staphylococcus lugdunensis*, 13 Staphylococcus warneri*, 14 Streptococcus mitisgroup , 15 Streptococcus oralis, 16 Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Besifloxacin ophthalmic suspension 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ®†(polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). Each mL of besifloxacin ophthalmic suspension contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8‑chloro fluoroquinolone anti-infective for topical ophthalmic use. Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Besifloxacin hydrochloride is a white to pale yellowish-white powder. Each mL contains. Active:besifloxacin 0.6% (6 mg/mL);. Inactives:polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative:benzalkonium chloride 0.01%. Besifloxacin ophthalmic suspension is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>82260-466-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-466-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0466-05</NDC11Code>
<ProductNDC>82260-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besivance</ProprietaryName>
<NonProprietaryName>Besifloxacin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260109</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022308</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>BESIFLOXACIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Besifloxacin ophthalmic suspension 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: 1 Aerococcus viridans* , 2 CDC coryneform group G, 3 Corynebacterium pseudodiphtheriticum*, 4 Corynebacterium striatum*, 5 Haemophilus influenzae, 6 Moraxella catarrhalis*, 7 Moraxella lacunata*, 8 Pseudomonas aeruginosa*, 9 Staphylococcus aureus, 10 Staphylococcus epidermidis, 11 Staphylococcus hominis*, 12 Staphylococcus lugdunensis*, 13 Staphylococcus warneri*, 14 Streptococcus mitisgroup , 15 Streptococcus oralis, 16 Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Besifloxacin ophthalmic suspension 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ®†(polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). Each mL of besifloxacin ophthalmic suspension contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8‑chloro fluoroquinolone anti-infective for topical ophthalmic use. Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Besifloxacin hydrochloride is a white to pale yellowish-white powder. Each mL contains. Active:besifloxacin 0.6% (6 mg/mL);. Inactives:polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative:benzalkonium chloride 0.01%. Besifloxacin ophthalmic suspension is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>82260-630-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0630-05</NDC11Code>
<ProductNDC>82260-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bepotastine Besilate</ProprietaryName>
<NonProprietaryName>Bepotastine Besilate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20210528</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022288</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>BEPOTASTINE BESYLATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H 1receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.</IndicationAndUsage>
<Description>Bepotastine Besilate Ophthalmic Solution, 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of Bepotastine Besilate Ophthalmic Solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is. Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine Besilate Ophthalmic Solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of Bepotastine Besilate Ophthalmic Solution, 1.5% is approximately 295 mOsm/kg. Each mL of Bepotastine Besilate Ophthalmic Solution, 1.5% contains: 1 Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine), 2 Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP, 3 Preservative: benzalkonium chloride 0.005%.</Description>
</NDC>
<NDC>
<NDCCode>82260-734-05</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (82260-734-05) / 5 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>82260-0734-05</NDC11Code>
<ProductNDC>82260-734</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorescein Sodium And Benoxinate Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluorescein Sodium And Benoxinate Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20200320</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA211039</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.6; 4.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent.</IndicationAndUsage>
<Description>Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a sterile solution containing a disclosing agent in combination with a short-acting ester anesthetic for topical ophthalmic use. Fluorescein sodium is represented by the following structural formula. Chemical Name: 3’,6’ Dihydroxy-3H-spiro[isobenzofuran-1,9-xanthen]-3-one disodium salt. Benoxinate hydrochloride is represented by the following structural formula. Chemical Name: 2-(Diethylamino) ethyl 4-amino-3-butoxybenzoate hydrochloride. Each mL of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution 0.3%/0.4% contains: 1 Active ingredients:fluorescein sodium 2.6 mg (0.3%) equivalent to fluorescein 2.3 mg (0.2%), benoxinate hydrochloride 4.4 mg (0.4%) equivalent to benoxinate 3.9 mg (0.4%) , 2 Preservative:chlorobutanol 12.6 mg (1.3%) , 3 Inactive ingredients:povidone, hydrochloric acid, boric acid, water for injection. Hydrochloric acid may be added to adjust pH (4.3 – 5.3). .</Description>
</NDC>
<NDC>
<NDCCode>82260-812-05</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (82260-812-05) / 5 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>82260-0812-05</NDC11Code>
<ProductNDC>82260-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018086</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol Maleate Ophthalmic Solution is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. Its molecular formula is C 13H 24N 4O 3SC 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolality is 260-340 mOsm/kg. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and purified water. Benzalkonium chloride 0.01% is added as preservative.</Description>
</NDC>
<NDC>
<NDCCode>82260-813-05</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (82260-813-05) / 5 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>82260-0813-05</NDC11Code>
<ProductNDC>82260-813</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018086</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</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>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol Maleate Ophthalmic Solution is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. Its molecular formula is C 13H 24N 4O 3SC 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolality is 260-340 mOsm/kg. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and purified water. Benzalkonium chloride 0.01% is added as preservative.</Description>
</NDC>
<NDC>
<NDCCode>82260-819-05</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>82260-0819-05</NDC11Code>
<ProductNDC>82260-819</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20180214</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020330</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</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>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Sterile Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. 25°. [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C 13H 24N 4O 3SC 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; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol Maleate Ophthalmic Gel Forming Solution forms a gel that is subsequently removed by the flow of tears.</Description>
</NDC>
<NDC>
<NDCCode>82260-920-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-920-05) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0920-05</NDC11Code>
<ProductNDC>82260-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA210821</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>TETRACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.</IndicationAndUsage>
<Description>Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a sterile, clear, colorless, topical local anesthetic for ophthalmic use only containing tetracaine hydrochloride as the active pharmaceutical ingredient. Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-, 2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C 15H 24N 2O 2● HCl and it is represented by the chemical structure:. Tetracaine hydrochloride is a fine, white, crystalline, odorless powder with a molecular weight of 300.83. Active ingredient:tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine). Preservative:chlorobutanol 0.4%. Inactive ingredients:boric acid, edetate disodium dihydrate, potassium chloride, water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH (3.7 – 6.0).</Description>
</NDC>
<NDC>
<NDCCode>82260-045-25</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-045-25) / 2.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0045-25</NDC11Code>
<ProductNDC>82260-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021516</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</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>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>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. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate 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 Timolol Maleate Ophthalmic Solution 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>82260-602-03</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82260-602-03) / 3 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82260-0602-03</NDC11Code>
<ProductNDC>82260-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bromfenac Ophthalmic Solution</ProprietaryName>
<NonProprietaryName>Bromfenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240108</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA203168</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</LabelerName>
<SubstanceName>BROMFENAC SODIUM</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bromfenac Ophthalmic Solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.</IndicationAndUsage>
<Description>Bromfenac Ophthalmic Solution 0.07% is a sterile, nonsteroidal anti-inflammatory drug (NSAID) for topical ophthalmic use. Each mL of Bromfenac Ophthalmic Solution contains 0.805 mg bromfenac sodium sesquihydrate (equivalent to 0.7 mg bromfenac free acid). The USAN name for bromfenac sodium sesquihydrate is bromfenac sodium. Bromfenac sodium is designated chemically as sodium [2-amino-3-(4-bromobenzoyl) phenyl] acetate sesquihydrate, with an empirical formula of C 15H 11BrNNaO 3 1½H 2O. The chemical structure for bromfenac sodium sesquihydrate is:. Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17. Bromfenac Ophthalmic Solution ophthalmic solution is supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The osmolality of Bromfenac Ophthalmic Solution is approximately 300 mOsmol/kg. Each mL of Bromfenac Ophthalmic Solution contains. Active:Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free acid 0.07%. Inactives:boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH, and water for injection, USP. Preservative:benzalkonium chloride 0.005%.</Description>
</NDC>
<NDC>
<NDCCode>82260-813-10</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (82260-813-10) / 10 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>82260-0813-10</NDC11Code>
<ProductNDC>82260-813</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018086</ApplicationNumber>
<LabelerName>Bausch & Lomb Americas Inc.</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>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol Maleate Ophthalmic Solution is a non-selective beta-adrenergic receptor blocking agent. 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. The optical rotation of timolol maleate is:. Its molecular formula is C 13H 24N 4O 3SC 4H 4O 4and its structural formula is:. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Ophthalmic Solution is stable at room temperature. Timolol Maleate Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. Each mL of Timolol Maleate Ophthalmic Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolality is 260-340 mOsm/kg. Each mL of Timolol Maleate Ophthalmic Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and purified water. Benzalkonium chloride 0.01% is added as preservative.</Description>
</NDC>
<NDC>
<NDCCode>0009-0039-06</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (0009-0039-06) / 1 mL in 1 VIAL (0009-0039-05) </PackageDescription>
<NDC11Code>00009-0039-06</NDC11Code>
<ProductNDC>0009-0039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19590402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011856</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19590402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. SOLU-MEDROL is available in preservative and preservative-free formulations. When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
</NDC>
<NDC>
<NDCCode>24236-496-20</NDCCode>
<PackageDescription>100 TABLET in 1 CANISTER (24236-496-20)</PackageDescription>
<NDC11Code>24236-0496-20</NDC11Code>
<ProductNDC>24236-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trihexyphenidyl Hydrochloride</ProprietaryName>
<NonProprietaryName>Trihexyphenidyl Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040337</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TRIHEXYPHENIDYL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-05-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>31722-496-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (31722-496-18) </PackageDescription>
<NDC11Code>31722-0496-18</NDC11Code>
<ProductNDC>31722-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219332</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).</IndicationAndUsage>
<Description>Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxabantablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxzolidin-5-yl}methyl)thiophene-2-carboxamide. The molecular formula of rivaroxaban is C19H18C1N3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxy propyl methyl cellulose, sodium lauryl sulfate and magnesium stearate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Aquarius Prime Yellow, containing hypromellose, D&C yellow no.10 aluminum lake, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-496-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-496-60) </PackageDescription>
<NDC11Code>31722-0496-60</NDC11Code>
<ProductNDC>31722-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219332</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 2 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8).</IndicationAndUsage>
<Description>Rivaroxaban, USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxabantablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxzolidin-5-yl}methyl)thiophene-2-carboxamide. The molecular formula of rivaroxaban is C19H18C1N3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablet, USP contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxy propyl methyl cellulose, sodium lauryl sulfate and magnesium stearate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets, USP 2.5 mg is Aquarius Prime Yellow, containing hypromellose, D&C yellow no.10 aluminum lake, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>45802-496-14</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-496-14) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0496-14</NDC11Code>
<ProductNDC>45802-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077770</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>45802-496-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-496-96) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0496-96</NDC11Code>
<ProductNDC>45802-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077770</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum. The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
</NDCList>