{
"NDC": [
{
"NDCCode": "64679-604-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (64679-604-16) ",
"NDC11Code": "64679-0604-16",
"ProductNDC": "64679-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19850104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088864",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "15; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19850104",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7.0%. Inactive Ingredients: artificial pineapple flavor, artificial raspberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Yellow No. 6, glycerin, sucrose, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-Methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C 18H 25NOHBrH 2O, and the following structural formula:. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10 H-Phenothiazine-10-ethanamine, N, N, α-trimethyl-, monohydrochloride, (±)-. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17H 20N 2SHCl, and the following structural formula:."
},
{
"NDCCode": "64679-608-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (64679-608-16) ",
"NDC11Code": "64679-0608-16",
"ProductNDC": "64679-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19821115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087953",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19821115",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.",
"Description": "Each 5 mL (teaspoonful) of Promethazine contains 6.25 mg of promethazine HCl. The inactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, glycerin, sucrose, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sodium propionate. Promethazine HCl is a racemic compound; the molecular formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol."
},
{
"NDCCode": "64679-716-03",
"PackageDescription": "16 BLISTER PACK in 1 CARTON (64679-716-03) > 8 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64679-0716-03",
"ProductNDC": "64679-716",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078865",
"LabelerName": "Wockhardt USA LLC.",
"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": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110414",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules, USP are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine 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 as follows:. Venlafaxine hydrochloride, USP is a white to off-white powder, freely soluble in water and in methanol, soluble in anhydrous ethanol and practically insoluble in acetone. Venlafaxine hydrochloride extended-release capsule is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, colloidal anhydrous silica, ethyl cellulose, gelatin, methacrylic acid copolymer type C, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The 37.5 mg and 75 mg capsules also contain D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. The 150 mg capsule also contains D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. Meets USP Dissolution Test 8."
},
{
"NDCCode": "64679-717-03",
"PackageDescription": "16 BLISTER PACK in 1 CARTON (64679-717-03) > 8 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64679-0717-03",
"ProductNDC": "64679-717",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078865",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110414",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules, USP are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine 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 as follows:. Venlafaxine hydrochloride, USP is a white to off-white powder, freely soluble in water and in methanol, soluble in anhydrous ethanol and practically insoluble in acetone. Venlafaxine hydrochloride extended-release capsule is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, colloidal anhydrous silica, ethyl cellulose, gelatin, methacrylic acid copolymer type C, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The 37.5 mg and 75 mg capsules also contain D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. The 150 mg capsule also contains D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. Meets USP Dissolution Test 8."
},
{
"NDCCode": "64679-718-03",
"PackageDescription": "16 BLISTER PACK in 1 CARTON (64679-718-03) > 8 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64679-0718-03",
"ProductNDC": "64679-718",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078865",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110414",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules, USP are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine 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 as follows:. Venlafaxine hydrochloride, USP is a white to off-white powder, freely soluble in water and in methanol, soluble in anhydrous ethanol and practically insoluble in acetone. Venlafaxine hydrochloride extended-release capsule is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, colloidal anhydrous silica, ethyl cellulose, gelatin, methacrylic acid copolymer type C, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The 37.5 mg and 75 mg capsules also contain D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. The 150 mg capsule also contains D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. Meets USP Dissolution Test 8."
},
{
"NDCCode": "64679-987-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (64679-987-24) > 90 TABLET, FILM COATED in 1 BOTTLE (64679-987-16) ",
"NDC11Code": "64679-0987-24",
"ProductNDC": "64679-987",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy 24-hr",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079112",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120208",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "50844-604-16",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-16) ",
"NDC11Code": "50844-0604-16",
"ProductNDC": "50844-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204872",
"LabelerName": "L.N.K. International, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170201",
"SamplePackage": "N"
},
{
"NDCCode": "54859-604-16",
"PackageDescription": "473 mL in 1 BOTTLE (54859-604-16) ",
"NDC11Code": "54859-0604-16",
"ProductNDC": "54859-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tusnel Pediatric",
"ProprietaryNameSuffix": "Dm",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Llorens Pharmaceutical International Division, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "5; 75; 2.5",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants , 2 helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold."
},
{
"NDCCode": "60432-604-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (60432-604-16) ",
"NDC11Code": "60432-0604-16",
"ProductNDC": "60432-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19850104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088864",
"LabelerName": "Morton Grove Pharmaceuticals, Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "15; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19850104",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7.0%. Inactive Ingredients: artificial pineapple flavor, artificial raspberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Yellow No. 6, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-Methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)-. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCl, and the following structural formula."
},
{
"NDCCode": "66915-604-16",
"PackageDescription": "65 g in 1 JAR (66915-604-16)",
"NDC11Code": "66915-0604-16",
"ProductNDC": "66915-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Spf 28",
"NonProprietaryName": "Zinc Oxide 11.6%, Titanium Dioxide 0.67%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131202",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CoValence, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".0067; .116",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2015-08-21",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "70338-604-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (70338-604-16) ",
"NDC11Code": "70338-0604-16",
"ProductNDC": "70338-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "MedZone Products, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".625",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "71321-604-16",
"PackageDescription": "473 mL in 1 BOTTLE (71321-604-16) ",
"NDC11Code": "71321-0604-16",
"ProductNDC": "71321-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oral Citrate Solution",
"NonProprietaryName": "Citric Acid And Sodium Citrate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240221",
"EndMarketingDate": "20260212",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Brandywine Pharmaceuticals, LLC",
"SubstanceName": "CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": "640; 490",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240221",
"EndMarketingDatePackage": "20260212",
"SamplePackage": "N",
"IndicationAndUsage": "Oral Citrate Solution is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long-term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). Oral Citrate Solution is also effective in treatment for acidosis of certain renal tubular disorders.",
"Description": "The product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution."
},
{
"NDCCode": "11673-604-85",
"PackageDescription": "1 BOTTLE in 1 CARTON (11673-604-85) > 250 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "11673-0604-85",
"ProductNDC": "11673-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072096",
"LabelerName": "Target Corporation",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090603",
"SamplePackage": "N"
},
{
"NDCCode": "11673-604-93",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (11673-604-93) ",
"NDC11Code": "11673-0604-93",
"ProductNDC": "11673-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072096",
"LabelerName": "Target Corporation",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170210",
"SamplePackage": "N"
},
{
"NDCCode": "13537-604-18",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-604-18) > 30 g in 1 BOTTLE (13537-604-17)",
"NDC11Code": "13537-0604-18",
"ProductNDC": "13537-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
"ProprietaryNameSuffix": "(medium 5) - Brown",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140428",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13537-604-20",
"PackageDescription": "1 TUBE in 1 BOX (13537-604-20) > 3 g in 1 TUBE (13537-604-19)",
"NDC11Code": "13537-0604-20",
"ProductNDC": "13537-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
"ProprietaryNameSuffix": "(medium 5) - Brown",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140428",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-604-18",
"PackageDescription": "1 BOTTLE in 1 BOX (14783-604-18) > 30 g in 1 BOTTLE (14783-604-17)",
"NDC11Code": "14783-0604-18",
"ProductNDC": "14783-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
"ProprietaryNameSuffix": "(medium 5) - Brown",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140428",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-604-20",
"PackageDescription": "1 TUBE in 1 BOX (14783-604-20) > 3 g in 1 TUBE (14783-604-19)",
"NDC11Code": "14783-0604-20",
"ProductNDC": "14783-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
"ProprietaryNameSuffix": "(medium 5) - Brown",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140428",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "24909-604-10",
"PackageDescription": "10 g in 1 JAR (24909-604-10)",
"NDC11Code": "24909-0604-10",
"ProductNDC": "24909-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fastrin Aches And Pain Deep Relief",
"NonProprietaryName": "Menthol, Camphor",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "MENTHOL; CAMPHOR (SYNTHETIC)",
"StrengthNumber": "16; 11",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "24909-604-50",
"PackageDescription": "50 g in 1 TUBE (24909-604-50)",
"NDC11Code": "24909-0604-50",
"ProductNDC": "24909-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fastrin Aches And Pain Deep Relief",
"NonProprietaryName": "Menthol, Camphor",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "MENTHOL; CAMPHOR (SYNTHETIC)",
"StrengthNumber": "16; 11",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "43068-610-09",
"PackageDescription": "1 KIT in 1 CARTON (43068-610-09) * 1 BLISTER PACK in 1 CARTON (43068-606-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-609-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-608-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-607-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-611-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-605-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-604-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-603-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-602-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "43068-0610-09",
"ProductNDC": "43068-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ponvory",
"NonProprietaryName": "Ponesimod",
"DosageFormName": "KIT",
"StartMarketingDate": "20210318",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213498",
"LabelerName": "Vanda Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "PONVORY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "PONVORY (ponesimod) is a sphingosine 1-phosphate receptor modulator. The chemical name for ponesimod is (2Z,5Z)-5-[3-chloro-4-[(2R)-2,3- dihydroxypropoxy]benzylidene]-3-(2-methylphenyl)-2-(propylimino)-1,3-thiazolidin-4-one. It has one chiral center with absolute configuration of (R). Its molecular formula is C23H25ClN2O4S and its molecular weight is 460.97 g/mol. Ponesimod has the following structural formula. Ponesimod is a white to light yellowish powder that is practically insoluble or insoluble in water. PONVORY® (ponesimod) tablets are provided as 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20 mg film-coated tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, silica colloidal anhydrous, and sodium lauryl sulfate. Each tablet coating contains ferrosoferric oxide (included in 4 mg, 5 mg, 8 mg, and 9 mg film-coated tablets), hydroxypropyl methylcellulose 2910, iron oxide red (included in 3 mg, 4 mg, 7 mg, 8 mg, 9 mg, and 10 mg film-coated tablets), iron oxide yellow (included in 3 mg, 5 mg, 7 mg, 9 mg, 10 mg, and 20 mg film-coated tablets), lactose monohydrate, polyethylene glycol 3350, titanium dioxide, and triacetin."
},
{
"NDCCode": "44183-604-30",
"PackageDescription": "1 BOTTLE in 1 BOX (44183-604-30) > 30 mL in 1 BOTTLE",
"NDC11Code": "44183-0604-30",
"ProductNDC": "44183-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cardec",
"NonProprietaryName": "Phenylephrine Hydrochloride And Chlorpheniramine Maleate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110609",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Macoven Pharmaceuticals",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "1; 3.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "55910-604-76",
"PackageDescription": "1 BOTTLE in 1 CARTON (55910-604-76) > 120 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "55910-0604-76",
"ProductNDC": "55910-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072096",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120509",
"SamplePackage": "N"
},
{
"NDCCode": "59923-604-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (59923-604-02) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "59923-0604-02",
"ProductNDC": "59923-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fludarabine Phosphate",
"NonProprietaryName": "Fludarabine Phosphate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090724",
"LabelerName": "Areva Pharmaceuticals",
"SubstanceName": "FLUDARABINE PHOSPHATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191231",
"SamplePackage": "N",
"IndicationAndUsage": "Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for. The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in treatment-naïve or non-refractory CLL patients is not established. (1.1).",
"Description": "Fludarabine Phosphate Injection contains fludarabine phosphate, a nucleotide metabolic inhibitor. Fludarabine phosphate is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9- ß-D-arabinofuranosyladenine (ara-A), that is relatively resistant to deamination by adenosine deaminase. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0- phosphono- ß-D-arabinofuranosyl)(2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C 10H 13FN 5O 7P (MW 365.2) and the structure is provided in Figure 1. Figure 1: Chemical Structure of Fludarabine Phosphate. Each mL contains 25 mg of the active ingredient fludarabine phosphate, 25 mg of mannitol, water for injection, q.s.; and sodium hydroxide to adjust pH to 6.8. The pH range for the final product is 6.0 to 7.1. Fludarabine Phosphate Injection is a sterile solution intended for intravenous administration."
},
{
"NDCCode": "60687-604-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-604-01) / 1 TABLET in 1 BLISTER PACK (60687-604-11) ",
"NDC11Code": "60687-0604-01",
"ProductNDC": "60687-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211231",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202800",
"LabelerName": "American Health Packaging",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211231",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia,, 2 Have not been tolerated, or are not expected to be tolerated.",
"Description": "Acetaminophen and codeine phosphate tablets, are supplied in tablet form for oral administration. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C 8H 9NO 2 M.W. 151.16. Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α- ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. C 18H 21NO 3H 3PO 41/2 H 2O M.W. 406.37. Each tablet contains: Acetaminophen............................300 mg Codeine Phosphate........................15 mg (Warning: May be habit forming). OR. Acetaminophen............................300 mg Codeine Phosphate........................30 mg (Warning: May be habit forming). OR. Acetaminophen............................300 mg Codeine Phosphate........................60 mg (Warning: May be habit forming). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and stearic acid."
},
{
"NDCCode": "64850-604-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (64850-604-01) ",
"NDC11Code": "64850-0604-01",
"ProductNDC": "64850-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210484",
"LabelerName": "Elite Laboratories, Inc.",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180806",
"SamplePackage": "N",
"IndicationAndUsage": "Methadone Hydrochloride Tablets are indicated for the. 1. Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use : 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Methadone Hydrochloride Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic. (1).",
"Description": "Methadone Hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a fine white powder. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of methadone hydrochloride. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose and pregelatinized starch."
},
{
"NDCCode": "64980-604-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (64980-604-01) ",
"NDC11Code": "64980-0604-01",
"ProductNDC": "64980-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090767",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam, USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (dark pink), and 1,000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below:250 mg tablets: FD&C Blue #2/Indigo Carmine Aluminum Lake500 mg tablets: Iron Oxide Yellow750 mg tablets: FD&C Red #40/Allura Red A C Aluminum Lake."
},
{
"NDCCode": "64980-604-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (64980-604-12) ",
"NDC11Code": "64980-0604-12",
"ProductNDC": "64980-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090767",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam, USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (dark pink), and 1,000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below:250 mg tablets: FD&C Blue #2/Indigo Carmine Aluminum Lake500 mg tablets: Iron Oxide Yellow750 mg tablets: FD&C Red #40/Allura Red A C Aluminum Lake."
},
{
"NDCCode": "64980-604-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64980-604-50) ",
"NDC11Code": "64980-0604-50",
"ProductNDC": "64980-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090767",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240610",
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"IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam, USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (dark pink), and 1,000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below:250 mg tablets: FD&C Blue #2/Indigo Carmine Aluminum Lake500 mg tablets: Iron Oxide Yellow750 mg tablets: FD&C Red #40/Allura Red A C Aluminum Lake."
},
{
"NDCCode": "68001-604-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-604-00) ",
"NDC11Code": "68001-0604-00",
"ProductNDC": "68001-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Macrocrystals",
"NonProprietaryName": "Nitrofurantoin Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217272",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231011",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiellaand Enterobacterspecies. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula:C 8H 6N 4O 5 Molecular Weight:238.16 g/mole. 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione. Inactive Ingredients:Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide. Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac."
}
]
}
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<NDCList>
<NDC>
<NDCCode>64679-604-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (64679-604-16) </PackageDescription>
<NDC11Code>64679-0604-16</NDC11Code>
<ProductNDC>64679-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19850104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088864</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7.0%. Inactive Ingredients: artificial pineapple flavor, artificial raspberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Yellow No. 6, glycerin, sucrose, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-Methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C 18H 25NOHBrH 2O, and the following structural formula:. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10 H-Phenothiazine-10-ethanamine, N, N, α-trimethyl-, monohydrochloride, (±)-. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17H 20N 2SHCl, and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>64679-608-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (64679-608-16) </PackageDescription>
<NDC11Code>64679-0608-16</NDC11Code>
<ProductNDC>64679-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19821115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087953</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19821115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine is useful for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.</IndicationAndUsage>
<Description>Each 5 mL (teaspoonful) of Promethazine contains 6.25 mg of promethazine HCl. The inactive ingredients present are artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, glycerin, sucrose, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, and sodium propionate. Promethazine HCl is a racemic compound; the molecular formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>64679-716-03</NDCCode>
<PackageDescription>16 BLISTER PACK in 1 CARTON (64679-716-03) > 8 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0716-03</NDC11Code>
<ProductNDC>64679-716</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078865</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</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>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules, USP are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine 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 as follows:. Venlafaxine hydrochloride, USP is a white to off-white powder, freely soluble in water and in methanol, soluble in anhydrous ethanol and practically insoluble in acetone. Venlafaxine hydrochloride extended-release capsule is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, colloidal anhydrous silica, ethyl cellulose, gelatin, methacrylic acid copolymer type C, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The 37.5 mg and 75 mg capsules also contain D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. The 150 mg capsule also contains D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. Meets USP Dissolution Test 8.</Description>
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<NDCCode>64679-717-03</NDCCode>
<PackageDescription>16 BLISTER PACK in 1 CARTON (64679-717-03) > 8 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0717-03</NDC11Code>
<ProductNDC>64679-717</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078865</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</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>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules, USP are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine 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 as follows:. Venlafaxine hydrochloride, USP is a white to off-white powder, freely soluble in water and in methanol, soluble in anhydrous ethanol and practically insoluble in acetone. Venlafaxine hydrochloride extended-release capsule is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, colloidal anhydrous silica, ethyl cellulose, gelatin, methacrylic acid copolymer type C, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The 37.5 mg and 75 mg capsules also contain D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. The 150 mg capsule also contains D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. Meets USP Dissolution Test 8.</Description>
</NDC>
<NDC>
<NDCCode>64679-718-03</NDCCode>
<PackageDescription>16 BLISTER PACK in 1 CARTON (64679-718-03) > 8 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0718-03</NDC11Code>
<ProductNDC>64679-718</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078865</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</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>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules, USP are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: 1 Major Depressive Disorder (MDD), 2 Generalized Anxiety Disorder (GAD), 3 Social Anxiety Disorder (SAD), 4 Panic Disorder (PD).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine 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 as follows:. Venlafaxine hydrochloride, USP is a white to off-white powder, freely soluble in water and in methanol, soluble in anhydrous ethanol and practically insoluble in acetone. Venlafaxine hydrochloride extended-release capsule is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, colloidal anhydrous silica, ethyl cellulose, gelatin, methacrylic acid copolymer type C, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The 37.5 mg and 75 mg capsules also contain D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. The 150 mg capsule also contains D & C red # 28, FD & C blue # 1, and FD & C yellow # 6. Meets USP Dissolution Test 8.</Description>
</NDC>
<NDC>
<NDCCode>64679-987-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64679-987-24) > 90 TABLET, FILM COATED in 1 BOTTLE (64679-987-16) </PackageDescription>
<NDC11Code>64679-0987-24</NDC11Code>
<ProductNDC>64679-987</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy 24-hr</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079112</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50844-604-16</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-16) </PackageDescription>
<NDC11Code>50844-0604-16</NDC11Code>
<ProductNDC>50844-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204872</ApplicationNumber>
<LabelerName>L.N.K. International, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54859-604-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (54859-604-16) </PackageDescription>
<NDC11Code>54859-0604-16</NDC11Code>
<ProductNDC>54859-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tusnel Pediatric</ProprietaryName>
<ProprietaryNameSuffix>Dm</ProprietaryNameSuffix>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Llorens Pharmaceutical International Division, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 75; 2.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants , 2 helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60432-604-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (60432-604-16) </PackageDescription>
<NDC11Code>60432-0604-16</NDC11Code>
<ProductNDC>60432-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19850104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088864</ApplicationNumber>
<LabelerName>Morton Grove Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19850104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7.0%. Inactive Ingredients: artificial pineapple flavor, artificial raspberry flavor, ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium, FD&C Yellow No. 6, glycerin, liquid sugar, methylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-Methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NOHBrH2O, and the following structural formula. Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)-. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2SHCl, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>66915-604-16</NDCCode>
<PackageDescription>65 g in 1 JAR (66915-604-16)</PackageDescription>
<NDC11Code>66915-0604-16</NDC11Code>
<ProductNDC>66915-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Spf 28</ProprietaryName>
<NonProprietaryName>Zinc Oxide 11.6%, Titanium Dioxide 0.67%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CoValence, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.0067; .116</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-08-21</LastUpdate>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70338-604-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (70338-604-16) </PackageDescription>
<NDC11Code>70338-0604-16</NDC11Code>
<ProductNDC>70338-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>MedZone Products, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.625</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71321-604-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (71321-604-16) </PackageDescription>
<NDC11Code>71321-0604-16</NDC11Code>
<ProductNDC>71321-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oral Citrate Solution</ProprietaryName>
<NonProprietaryName>Citric Acid And Sodium Citrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240221</StartMarketingDate>
<EndMarketingDate>20260212</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Brandywine Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>640; 490</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240221</StartMarketingDatePackage>
<EndMarketingDatePackage>20260212</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral Citrate Solution is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long-term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). Oral Citrate Solution is also effective in treatment for acidosis of certain renal tubular disorders.</IndicationAndUsage>
<Description>The product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution.</Description>
</NDC>
<NDC>
<NDCCode>11673-604-85</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-604-85) > 250 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0604-85</NDC11Code>
<ProductNDC>11673-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072096</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11673-604-93</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (11673-604-93) </PackageDescription>
<NDC11Code>11673-0604-93</NDC11Code>
<ProductNDC>11673-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072096</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-604-18</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-604-18) > 30 g in 1 BOTTLE (13537-604-17)</PackageDescription>
<NDC11Code>13537-0604-18</NDC11Code>
<ProductNDC>13537-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
<ProprietaryNameSuffix>(medium 5) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-604-20</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-604-20) > 3 g in 1 TUBE (13537-604-19)</PackageDescription>
<NDC11Code>13537-0604-20</NDC11Code>
<ProductNDC>13537-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
<ProprietaryNameSuffix>(medium 5) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-604-18</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (14783-604-18) > 30 g in 1 BOTTLE (14783-604-17)</PackageDescription>
<NDC11Code>14783-0604-18</NDC11Code>
<ProductNDC>14783-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
<ProprietaryNameSuffix>(medium 5) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-604-20</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-604-20) > 3 g in 1 TUBE (14783-604-19)</PackageDescription>
<NDC11Code>14783-0604-20</NDC11Code>
<ProductNDC>14783-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
<ProprietaryNameSuffix>(medium 5) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-604-10</NDCCode>
<PackageDescription>10 g in 1 JAR (24909-604-10)</PackageDescription>
<NDC11Code>24909-0604-10</NDC11Code>
<ProductNDC>24909-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fastrin Aches And Pain Deep Relief</ProprietaryName>
<NonProprietaryName>Menthol, Camphor</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>16; 11</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-604-50</NDCCode>
<PackageDescription>50 g in 1 TUBE (24909-604-50)</PackageDescription>
<NDC11Code>24909-0604-50</NDC11Code>
<ProductNDC>24909-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fastrin Aches And Pain Deep Relief</ProprietaryName>
<NonProprietaryName>Menthol, Camphor</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>16; 11</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43068-610-09</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (43068-610-09) * 1 BLISTER PACK in 1 CARTON (43068-606-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-609-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-608-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-607-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-611-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-605-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-604-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-603-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-602-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>43068-0610-09</NDC11Code>
<ProductNDC>43068-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ponvory</ProprietaryName>
<NonProprietaryName>Ponesimod</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210318</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213498</ApplicationNumber>
<LabelerName>Vanda Pharmaceuticals Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PONVORY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>PONVORY (ponesimod) is a sphingosine 1-phosphate receptor modulator. The chemical name for ponesimod is (2Z,5Z)-5-[3-chloro-4-[(2R)-2,3- dihydroxypropoxy]benzylidene]-3-(2-methylphenyl)-2-(propylimino)-1,3-thiazolidin-4-one. It has one chiral center with absolute configuration of (R). Its molecular formula is C23H25ClN2O4S and its molecular weight is 460.97 g/mol. Ponesimod has the following structural formula. Ponesimod is a white to light yellowish powder that is practically insoluble or insoluble in water. PONVORY® (ponesimod) tablets are provided as 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20 mg film-coated tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, silica colloidal anhydrous, and sodium lauryl sulfate. Each tablet coating contains ferrosoferric oxide (included in 4 mg, 5 mg, 8 mg, and 9 mg film-coated tablets), hydroxypropyl methylcellulose 2910, iron oxide red (included in 3 mg, 4 mg, 7 mg, 8 mg, 9 mg, and 10 mg film-coated tablets), iron oxide yellow (included in 3 mg, 5 mg, 7 mg, 9 mg, 10 mg, and 20 mg film-coated tablets), lactose monohydrate, polyethylene glycol 3350, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>44183-604-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (44183-604-30) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>44183-0604-30</NDC11Code>
<ProductNDC>44183-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cardec</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride And Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Macoven Pharmaceuticals</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 3.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>55910-604-76</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55910-604-76) > 120 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>55910-0604-76</NDC11Code>
<ProductNDC>55910-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dg Health Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072096</ApplicationNumber>
<LabelerName>Dolgencorp, LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59923-604-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (59923-604-02) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>59923-0604-02</NDC11Code>
<ProductNDC>59923-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fludarabine Phosphate</ProprietaryName>
<NonProprietaryName>Fludarabine Phosphate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090724</ApplicationNumber>
<LabelerName>Areva Pharmaceuticals</LabelerName>
<SubstanceName>FLUDARABINE PHOSPHATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for. The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in treatment-naïve or non-refractory CLL patients is not established. (1.1).</IndicationAndUsage>
<Description>Fludarabine Phosphate Injection contains fludarabine phosphate, a nucleotide metabolic inhibitor. Fludarabine phosphate is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9- ß-D-arabinofuranosyladenine (ara-A), that is relatively resistant to deamination by adenosine deaminase. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0- phosphono- ß-D-arabinofuranosyl)(2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C 10H 13FN 5O 7P (MW 365.2) and the structure is provided in Figure 1. Figure 1: Chemical Structure of Fludarabine Phosphate. Each mL contains 25 mg of the active ingredient fludarabine phosphate, 25 mg of mannitol, water for injection, q.s.; and sodium hydroxide to adjust pH to 6.8. The pH range for the final product is 6.0 to 7.1. Fludarabine Phosphate Injection is a sterile solution intended for intravenous administration.</Description>
</NDC>
<NDC>
<NDCCode>60687-604-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-604-01) / 1 TABLET in 1 BLISTER PACK (60687-604-11) </PackageDescription>
<NDC11Code>60687-0604-01</NDC11Code>
<ProductNDC>60687-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211231</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202800</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211231</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia,, 2 Have not been tolerated, or are not expected to be tolerated.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate tablets, are supplied in tablet form for oral administration. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C 8H 9NO 2 M.W. 151.16. Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α- ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. C 18H 21NO 3H 3PO 41/2 H 2O M.W. 406.37. Each tablet contains: Acetaminophen............................300 mg Codeine Phosphate........................15 mg (Warning: May be habit forming). OR. Acetaminophen............................300 mg Codeine Phosphate........................30 mg (Warning: May be habit forming). OR. Acetaminophen............................300 mg Codeine Phosphate........................60 mg (Warning: May be habit forming). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>64850-604-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (64850-604-01) </PackageDescription>
<NDC11Code>64850-0604-01</NDC11Code>
<ProductNDC>64850-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210484</ApplicationNumber>
<LabelerName>Elite Laboratories, Inc.</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methadone Hydrochloride Tablets are indicated for the. 1. Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use : 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Methadone Hydrochloride Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic. (1).</IndicationAndUsage>
<Description>Methadone Hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a fine white powder. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Methadone Hydrochloride Tablets are available for oral administration containing either 5 mg or 10 mg of methadone hydrochloride. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>64980-604-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (64980-604-01) </PackageDescription>
<NDC11Code>64980-0604-01</NDC11Code>
<ProductNDC>64980-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090767</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam, USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (dark pink), and 1,000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below:250 mg tablets: FD&C Blue #2/Indigo Carmine Aluminum Lake500 mg tablets: Iron Oxide Yellow750 mg tablets: FD&C Red #40/Allura Red A C Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>64980-604-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (64980-604-12) </PackageDescription>
<NDC11Code>64980-0604-12</NDC11Code>
<ProductNDC>64980-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090767</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam, USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (dark pink), and 1,000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below:250 mg tablets: FD&C Blue #2/Indigo Carmine Aluminum Lake500 mg tablets: Iron Oxide Yellow750 mg tablets: FD&C Red #40/Allura Red A C Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>64980-604-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (64980-604-50) </PackageDescription>
<NDC11Code>64980-0604-50</NDC11Code>
<ProductNDC>64980-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090767</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam, USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (dark pink), and 1,000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below:250 mg tablets: FD&C Blue #2/Indigo Carmine Aluminum Lake500 mg tablets: Iron Oxide Yellow750 mg tablets: FD&C Red #40/Allura Red A C Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>68001-604-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-604-00) </PackageDescription>
<NDC11Code>68001-0604-00</NDC11Code>
<ProductNDC>68001-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217272</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiellaand Enterobacterspecies. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula:C 8H 6N 4O 5 Molecular Weight:238.16 g/mole. 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione. Inactive Ingredients:Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide. Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac.</Description>
</NDC>
</NDCList>