{
"NDC": [
{
"NDCCode": "69680-130-92",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-92) ",
"NDC11Code": "69680-0130-92",
"ProductNDC": "69680-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210339",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.",
"Description": "Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4."
},
{
"NDCCode": "69680-130-60",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-60) ",
"NDC11Code": "69680-0130-60",
"ProductNDC": "69680-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210339",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.",
"Description": "Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4."
},
{
"NDCCode": "69680-131-92",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-131-92) ",
"NDC11Code": "69680-0131-92",
"ProductNDC": "69680-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210339",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.",
"Description": "Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4."
},
{
"NDCCode": "69680-132-92",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-132-92) ",
"NDC11Code": "69680-0132-92",
"ProductNDC": "69680-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210339",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "425",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.",
"Description": "Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4."
},
{
"NDCCode": "69680-133-92",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-133-92) ",
"NDC11Code": "69680-0133-92",
"ProductNDC": "69680-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209688",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200731",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 750 mg and 1500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq tablets also contain colloidal silicon dioxide, D&C Yellow No. 10 aluminum Lake, ethylcellulose, FD&C Yellow No. 6, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 20 mEq tablets also contain colloidal silicon dioxide, ethylcellulose, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. USP Dissolution Test pending."
},
{
"NDCCode": "69680-134-92",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-134-92) ",
"NDC11Code": "69680-0134-92",
"ProductNDC": "69680-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209688",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 750 mg and 1500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq tablets also contain colloidal silicon dioxide, D&C Yellow No. 10 aluminum Lake, ethylcellulose, FD&C Yellow No. 6, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 20 mEq tablets also contain colloidal silicon dioxide, ethylcellulose, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. USP Dissolution Test pending."
},
{
"NDCCode": "69680-143-92",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (69680-143-92) ",
"NDC11Code": "69680-0143-92",
"ProductNDC": "69680-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevelamer Carbonate",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212970",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210215",
"SamplePackage": "N"
},
{
"NDCCode": "69680-157-92",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-92) ",
"NDC11Code": "69680-0157-92",
"ProductNDC": "69680-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride (xl)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208652",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230410",
"SamplePackage": "N",
"Description": "Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: povidone, tartaric acid, glyceryl distearate, magnesium stearate, hydroxypropyl cellulose, ethylcellulose, methacrylic acid copolymer dispersion and colloidal silicon dioxide. The tablets are printed with black ink comprising of shellac glaze (modified) in SD-45, isopropyl alcohol, black iron oxide non-irradiated, n-butyl alcohol, propylene glycol and ammonium hydroxide. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test #4."
},
{
"NDCCode": "69680-158-92",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-158-92) ",
"NDC11Code": "69680-0158-92",
"ProductNDC": "69680-158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride (xl)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208652",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230410",
"SamplePackage": "N",
"Description": "Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: povidone, tartaric acid, glyceryl distearate, magnesium stearate, hydroxypropyl cellulose, ethylcellulose, methacrylic acid copolymer dispersion and colloidal silicon dioxide. The tablets are printed with black ink comprising of shellac glaze (modified) in SD-45, isopropyl alcohol, black iron oxide non-irradiated, n-butyl alcohol, propylene glycol and ammonium hydroxide. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test #4."
},
{
"NDCCode": "69680-186-92",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (69680-186-92) ",
"NDC11Code": "69680-0186-92",
"ProductNDC": "69680-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Icosapent Ethyl",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219156",
"LabelerName": "Vitruvias Therapeutics, Inc.",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251020",
"SamplePackage": "N",
"IndicationAndUsage": "Icosapent ethyl capsules is indicated: 1 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.",
"Description": "Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. Icosapent ethyl capsules contain the following inactive ingredients: gelatin, glycerin, purified water, and white ink. The compositions of white ink are isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "37000-049-92",
"PackageDescription": "2 CARTON in 1 CELLO PACK (37000-049-92) / 1 TUBE in 1 CARTON / 130 g in 1 TUBE",
"NDC11Code": "37000-0049-92",
"ProductNDC": "37000-049",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Crest Cavity Protection",
"ProprietaryNameSuffix": "Sparkle Fun",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20020905",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020905",
"SamplePackage": "N"
},
{
"NDCCode": "37000-187-92",
"PackageDescription": "2 CARTON in 1 CELLO PACK (37000-187-92) > 1 TUBE in 1 CARTON > 130 g in 1 TUBE",
"NDC11Code": "37000-0187-92",
"ProductNDC": "37000-187",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Pro-health",
"ProprietaryNameSuffix": "Clean Mint Gel",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N"
},
{
"NDCCode": "37000-209-92",
"PackageDescription": "2 TUBE in 1 CARTON (37000-209-92) / 130 g in 1 TUBE",
"NDC11Code": "37000-0209-92",
"ProductNDC": "37000-209",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Pro-health",
"ProprietaryNameSuffix": "Whitening",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N"
},
{
"NDCCode": "37000-215-92",
"PackageDescription": "2 TUBE in 1 CARTON (37000-215-92) / 130 g in 1 TUBE",
"NDC11Code": "37000-0215-92",
"ProductNDC": "37000-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest 3d White Whitening Therapy",
"ProprietaryNameSuffix": "Deep Clean Charcoal",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Procter & Gamble Manfuacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "37000-468-92",
"PackageDescription": "2 CARTON in 1 CELLO PACK (37000-468-92) > 1 TUBE in 1 CARTON > 130 g in 1 TUBE",
"NDC11Code": "37000-0468-92",
"ProductNDC": "37000-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Pro-health",
"ProprietaryNameSuffix": "Sensitivive And Enamel Shield",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20161102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-06-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "37000-604-92",
"PackageDescription": "2 CARTON in 1 CELLO PACK (37000-604-92) > 1 TUBE in 1 CARTON > 130 g in 1 TUBE",
"NDC11Code": "37000-0604-92",
"ProductNDC": "37000-604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Pro-health",
"ProprietaryNameSuffix": "With A Touch Of Scope",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20170617",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180104",
"SamplePackage": "N"
},
{
"NDCCode": "53157-130-92",
"PackageDescription": "24 BAG in 1 CARTON (53157-130-92) > 70 mL in 1 BAG",
"NDC11Code": "53157-0130-92",
"ProductNDC": "53157-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cpda-1 Blood Collection System",
"NonProprietaryName": "Blood Collection System",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19801106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN800077",
"LabelerName": "Haemonetics Corporation",
"SubstanceName": "ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
"StrengthNumber": ".019; .229; 2.23; 1.84; .155",
"StrengthUnit": "g/70mL; g/70mL; g/70mL; g/70mL; g/70mL",
"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": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19801106",
"SamplePackage": "N",
"IndicationAndUsage": "For collection of blood and preparation of red blood cells, plasma and platelets. Platelets are not intended to be produced when using ‘doubles’ .",
"Description": "CPDA-1 Blood Collection Set with Sampling System. Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok® Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex."
},
{
"NDCCode": "68135-181-93",
"PackageDescription": "1 KIT in 1 CARTON (68135-181-93) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-130-92) / .6 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-158-17) ",
"NDC11Code": "68135-0181-93",
"ProductNDC": "68135-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Voxzogo 1.2mg",
"NonProprietaryName": "Vosoritide",
"DosageFormName": "KIT",
"StartMarketingDate": "20211119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214938",
"LabelerName": "BioMarin Pharmaceutical Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211119",
"SamplePackage": "N",
"IndicationAndUsage": "VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "VOXZOGO contains vosoritide, a human C type natriuretic peptide (CNP) analog. Vosoritide is a 39 amino acid peptide. Its amino acid sequence includes the 37 C terminal amino acids of the human CNP53 sequence plus Pro Gly on the N terminus to convey resistance to neutral endopeptidase (NEP) degradation. Vosoritide is manufactured from Escherichia coli using recombinant DNA technology. Vosoritide has a chemical formula of C176H290N56O51S3 with a molecular weight of 4.1 kDa. Vosoritide has the structural formula shown in Figure 1. Figure 1. VOXZOGO (vosoritide) for injection, is a sterile, preservative-free white-to-yellow lyophilized powder, for subcutaneous administration after reconstitution with Sterile Water for Injection, USP. VOXZOGO is provided as a single-dose vial containing 0.4 mg, 0.56 mg, or 1.2 mg of vosoritide per vial. A pre-filled syringe containing Sterile Water for Injection, USP for use as a diluent is also provided. The contents of each single dose vial are summarized by strength in Table 4. The product contains no preservative."
},
{
"NDCCode": "69680-131-60",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-131-60) ",
"NDC11Code": "69680-0131-60",
"ProductNDC": "69680-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210339",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.",
"Description": "Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4."
},
{
"NDCCode": "69680-132-60",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-132-60) ",
"NDC11Code": "69680-0132-60",
"ProductNDC": "69680-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210339",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "425",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.",
"Description": "Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4."
},
{
"NDCCode": "0781-3531-91",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3531-91) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00781-3531-91",
"ProductNDC": "0781-3531",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212700",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "100",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241009",
"SamplePackage": "N",
"Description": "Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2 R,3 S)- N-benzoyl-3-phenylisoserine. The empirical formula is C 47H 51NO 14and the molecular weight is 853.92. Paclitaxel has the following structural formula:. Paclitaxel is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at approximately 213°C to 216°C. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single‑dose vial contains 100 mg of paclitaxel (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate). Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel formulated as albumin‑bound particles. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is free of solvents."
},
{
"NDCCode": "52747-620-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX (52747-620-10) > 4 CAPSULE in 1 BLISTER PACK (52747-620-04) ",
"NDC11Code": "52747-0620-10",
"ProductNDC": "52747-620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Concept Ob",
"NonProprietaryName": "Vitamin Mineral Supplement",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "U.S. Pharmaceutical Corporation",
"SubstanceName": "FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM; MANGANESE SULFATE; ZINC SULFATE, UNSPECIFIED FORM",
"StrengthNumber": "42.5; 42.5; 210; 1; 5; 5; 20; 7; 25; 300; 10; 800; 6.9; 1.3; 18.2",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090101",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: Concept OBTM is a prenatal supplement designed to improve the nutritional status for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept OBTM may also be used to improve the nutritional status of women before conception.",
"Description": "DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .....................................130 mg (Equivalent to about 42.5 mg of Elemental Iron) PolysaccharideIronComplex .....................................92.4mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..................................... 210 mg Folic Acid ................................................................................... 1 mg Thiamine Mononitrate (B1)................................................. 5 mg Riboflavin (B2).......................................................................... 5 mg Niacin (B3)...............................................................................20 mg d-Calcium Pantothenate (B5)............................................. 7 mg Pyridoxine HCl (B6) ..............................................................25 mg Biotin (B7)........................................................................... 300 mcg Cyanocobalamin (B12) .....................................................10 mcg Copper (as Copper Sulfate)..........................................800 mcg Magnesium (as Magnesium Sulfate)............................6.9 mg Manganese (as Manganese Sulfate).............................1.3 mg Zinc (as Zinc Sulfate) ....................................................... 18.2 mg Inactive Ingredients: Hypromellose, Silicon Dioxide, Magnesium Stearate, Carmine, and Candurin Silver Fine."
},
{
"NDCCode": "52747-620-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (52747-620-30) ",
"NDC11Code": "52747-0620-30",
"ProductNDC": "52747-620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Concept Ob",
"NonProprietaryName": "Vitamin Mineral Supplement",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "U.S. Pharmaceutical Corporation",
"SubstanceName": "FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM; MANGANESE SULFATE; ZINC SULFATE, UNSPECIFIED FORM",
"StrengthNumber": "42.5; 42.5; 210; 1; 5; 5; 20; 7; 25; 300; 10; 800; 6.9; 1.3; 18.2",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090101",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS: Concept OBTM is a prenatal supplement designed to improve the nutritional status for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept OBTM may also be used to improve the nutritional status of women before conception.",
"Description": "DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .....................................130 mg (Equivalent to about 42.5 mg of Elemental Iron) PolysaccharideIronComplex .....................................92.4mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..................................... 210 mg Folic Acid ................................................................................... 1 mg Thiamine Mononitrate (B1)................................................. 5 mg Riboflavin (B2).......................................................................... 5 mg Niacin (B3)...............................................................................20 mg d-Calcium Pantothenate (B5)............................................. 7 mg Pyridoxine HCl (B6) ..............................................................25 mg Biotin (B7)........................................................................... 300 mcg Cyanocobalamin (B12) .....................................................10 mcg Copper (as Copper Sulfate)..........................................800 mcg Magnesium (as Magnesium Sulfate)............................6.9 mg Manganese (as Manganese Sulfate).............................1.3 mg Zinc (as Zinc Sulfate) ....................................................... 18.2 mg Inactive Ingredients: Hypromellose, Silicon Dioxide, Magnesium Stearate, Carmine, and Candurin Silver Fine."
},
{
"NDCCode": "71093-130-01",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (71093-130-01) ",
"NDC11Code": "71093-0130-01",
"ProductNDC": "71093-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076881",
"LabelerName": "ACI Healthcare USA, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180820",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Post-traumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.5 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2.HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white to off-white, crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline Hydrochloride Tablets for oral administration contain 27.98 mg, 55.96 mg and 111.92 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "71093-130-03",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (71093-130-03) ",
"NDC11Code": "71093-0130-03",
"ProductNDC": "71093-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076881",
"LabelerName": "ACI Healthcare USA, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180820",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Post-traumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.5 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2.HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white to off-white, crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline Hydrochloride Tablets for oral administration contain 27.98 mg, 55.96 mg and 111.92 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "71093-130-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (71093-130-05) ",
"NDC11Code": "71093-0130-05",
"ProductNDC": "71093-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076881",
"LabelerName": "ACI Healthcare USA, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180820",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Post-traumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.5 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2.HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white to off-white, crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline Hydrochloride Tablets for oral administration contain 27.98 mg, 55.96 mg and 111.92 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "78206-130-01",
"PackageDescription": "1 KIT in 1 CARTON (78206-130-01) / 1 CARTRIDGE in 1 KIT / .72 mL in 1 CARTRIDGE (78206-130-99) ",
"NDC11Code": "78206-0130-01",
"ProductNDC": "78206-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Organon LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "600",
"StrengthUnit": "[iU]/.72mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230724",
"SamplePackage": "N",
"IndicationAndUsage": "FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "78206-130-59",
"PackageDescription": "1 KIT in 1 CARTON (78206-130-59) / 1 CARTRIDGE in 1 KIT / .72 mL in 1 CARTRIDGE (78206-130-58) ",
"NDC11Code": "78206-0130-59",
"ProductNDC": "78206-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Organon LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "600",
"StrengthUnit": "[iU]/.72mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230724",
"SamplePackage": "Y",
"IndicationAndUsage": "FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "69680-112-10",
"PackageDescription": "10 VIAL in 1 BOX (69680-112-10) / 1 mL in 1 VIAL (69680-112-01) ",
"NDC11Code": "69680-0112-10",
"ProductNDC": "69680-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyanocobalamin",
"NonProprietaryName": "Cyanocobalamin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209255",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "CYANOCOBALAMIN",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190615",
"SamplePackage": "N",
"IndicationAndUsage": "Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.",
"Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative and Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below."
},
{
"NDCCode": "69680-112-25",
"PackageDescription": "25 VIAL in 1 BOX (69680-112-25) / 1 mL in 1 VIAL (69680-112-01) ",
"NDC11Code": "69680-0112-25",
"ProductNDC": "69680-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyanocobalamin",
"NonProprietaryName": "Cyanocobalamin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209255",
"LabelerName": "Vitruvias Therapeutics",
"SubstanceName": "CYANOCOBALAMIN",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190102",
"SamplePackage": "N",
"IndicationAndUsage": "Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.",
"Description": "Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative and Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>69680-130-92</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-92) </PackageDescription>
<NDC11Code>69680-0130-92</NDC11Code>
<ProductNDC>69680-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210339</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.</IndicationAndUsage>
<Description>Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4.</Description>
</NDC>
<NDC>
<NDCCode>69680-130-60</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-60) </PackageDescription>
<NDC11Code>69680-0130-60</NDC11Code>
<ProductNDC>69680-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210339</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.</IndicationAndUsage>
<Description>Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4.</Description>
</NDC>
<NDC>
<NDCCode>69680-131-92</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-131-92) </PackageDescription>
<NDC11Code>69680-0131-92</NDC11Code>
<ProductNDC>69680-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210339</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.</IndicationAndUsage>
<Description>Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4.</Description>
</NDC>
<NDC>
<NDCCode>69680-132-92</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-132-92) </PackageDescription>
<NDC11Code>69680-0132-92</NDC11Code>
<ProductNDC>69680-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210339</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>425</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.</IndicationAndUsage>
<Description>Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4.</Description>
</NDC>
<NDC>
<NDCCode>69680-133-92</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-133-92) </PackageDescription>
<NDC11Code>69680-0133-92</NDC11Code>
<ProductNDC>69680-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209688</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 750 mg and 1500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq tablets also contain colloidal silicon dioxide, D&C Yellow No. 10 aluminum Lake, ethylcellulose, FD&C Yellow No. 6, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 20 mEq tablets also contain colloidal silicon dioxide, ethylcellulose, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>69680-134-92</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-134-92) </PackageDescription>
<NDC11Code>69680-0134-92</NDC11Code>
<ProductNDC>69680-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209688</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 750 mg and 1500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq tablets also contain colloidal silicon dioxide, D&C Yellow No. 10 aluminum Lake, ethylcellulose, FD&C Yellow No. 6, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 20 mEq tablets also contain colloidal silicon dioxide, ethylcellulose, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>69680-143-92</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (69680-143-92) </PackageDescription>
<NDC11Code>69680-0143-92</NDC11Code>
<ProductNDC>69680-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevelamer Carbonate</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212970</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69680-157-92</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-92) </PackageDescription>
<NDC11Code>69680-0157-92</NDC11Code>
<ProductNDC>69680-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride (xl)</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208652</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: povidone, tartaric acid, glyceryl distearate, magnesium stearate, hydroxypropyl cellulose, ethylcellulose, methacrylic acid copolymer dispersion and colloidal silicon dioxide. The tablets are printed with black ink comprising of shellac glaze (modified) in SD-45, isopropyl alcohol, black iron oxide non-irradiated, n-butyl alcohol, propylene glycol and ammonium hydroxide. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test #4.</Description>
</NDC>
<NDC>
<NDCCode>69680-158-92</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-158-92) </PackageDescription>
<NDC11Code>69680-0158-92</NDC11Code>
<ProductNDC>69680-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride (xl)</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208652</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: povidone, tartaric acid, glyceryl distearate, magnesium stearate, hydroxypropyl cellulose, ethylcellulose, methacrylic acid copolymer dispersion and colloidal silicon dioxide. The tablets are printed with black ink comprising of shellac glaze (modified) in SD-45, isopropyl alcohol, black iron oxide non-irradiated, n-butyl alcohol, propylene glycol and ammonium hydroxide. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test #4.</Description>
</NDC>
<NDC>
<NDCCode>69680-186-92</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (69680-186-92) </PackageDescription>
<NDC11Code>69680-0186-92</NDC11Code>
<ProductNDC>69680-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Icosapent Ethyl</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219156</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics, Inc.</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Icosapent ethyl capsules is indicated: 1 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.</IndicationAndUsage>
<Description>Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. Icosapent ethyl capsules contain the following inactive ingredients: gelatin, glycerin, purified water, and white ink. The compositions of white ink are isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>37000-049-92</NDCCode>
<PackageDescription>2 CARTON in 1 CELLO PACK (37000-049-92) / 1 TUBE in 1 CARTON / 130 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0049-92</NDC11Code>
<ProductNDC>37000-049</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kids Crest Cavity Protection</ProprietaryName>
<ProprietaryNameSuffix>Sparkle Fun</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20020905</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-187-92</NDCCode>
<PackageDescription>2 CARTON in 1 CELLO PACK (37000-187-92) > 1 TUBE in 1 CARTON > 130 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0187-92</NDC11Code>
<ProductNDC>37000-187</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Pro-health</ProprietaryName>
<ProprietaryNameSuffix>Clean Mint Gel</ProprietaryNameSuffix>
<NonProprietaryName>Stannous Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>STANNOUS FLUORIDE</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-209-92</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (37000-209-92) / 130 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0209-92</NDC11Code>
<ProductNDC>37000-209</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Pro-health</ProprietaryName>
<ProprietaryNameSuffix>Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Stannous Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>STANNOUS FLUORIDE</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-215-92</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (37000-215-92) / 130 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0215-92</NDC11Code>
<ProductNDC>37000-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest 3d White Whitening Therapy</ProprietaryName>
<ProprietaryNameSuffix>Deep Clean Charcoal</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Procter & Gamble Manfuacturing Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37000-468-92</NDCCode>
<PackageDescription>2 CARTON in 1 CELLO PACK (37000-468-92) > 1 TUBE in 1 CARTON > 130 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0468-92</NDC11Code>
<ProductNDC>37000-468</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Pro-health</ProprietaryName>
<ProprietaryNameSuffix>Sensitivive And Enamel Shield</ProprietaryNameSuffix>
<NonProprietaryName>Stannous Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20161102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>STANNOUS FLUORIDE</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-06-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37000-604-92</NDCCode>
<PackageDescription>2 CARTON in 1 CELLO PACK (37000-604-92) > 1 TUBE in 1 CARTON > 130 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0604-92</NDC11Code>
<ProductNDC>37000-604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Pro-health</ProprietaryName>
<ProprietaryNameSuffix>With A Touch Of Scope</ProprietaryNameSuffix>
<NonProprietaryName>Stannous Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20170617</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>STANNOUS FLUORIDE</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53157-130-92</NDCCode>
<PackageDescription>24 BAG in 1 CARTON (53157-130-92) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53157-0130-92</NDC11Code>
<ProductNDC>53157-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cpda-1 Blood Collection System</ProprietaryName>
<NonProprietaryName>Blood Collection System</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19801106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN800077</ApplicationNumber>
<LabelerName>Haemonetics Corporation</LabelerName>
<SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE</SubstanceName>
<StrengthNumber>.019; .229; 2.23; 1.84; .155</StrengthNumber>
<StrengthUnit>g/70mL; g/70mL; g/70mL; g/70mL; g/70mL</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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19801106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For collection of blood and preparation of red blood cells, plasma and platelets. Platelets are not intended to be produced when using ‘doubles’ .</IndicationAndUsage>
<Description>CPDA-1 Blood Collection Set with Sampling System. Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok® Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>68135-181-93</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (68135-181-93) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-130-92) / .6 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-158-17) </PackageDescription>
<NDC11Code>68135-0181-93</NDC11Code>
<ProductNDC>68135-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Voxzogo 1.2mg</ProprietaryName>
<NonProprietaryName>Vosoritide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20211119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214938</ApplicationNumber>
<LabelerName>BioMarin Pharmaceutical Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>VOXZOGO contains vosoritide, a human C type natriuretic peptide (CNP) analog. Vosoritide is a 39 amino acid peptide. Its amino acid sequence includes the 37 C terminal amino acids of the human CNP53 sequence plus Pro Gly on the N terminus to convey resistance to neutral endopeptidase (NEP) degradation. Vosoritide is manufactured from Escherichia coli using recombinant DNA technology. Vosoritide has a chemical formula of C176H290N56O51S3 with a molecular weight of 4.1 kDa. Vosoritide has the structural formula shown in Figure 1. Figure 1. VOXZOGO (vosoritide) for injection, is a sterile, preservative-free white-to-yellow lyophilized powder, for subcutaneous administration after reconstitution with Sterile Water for Injection, USP. VOXZOGO is provided as a single-dose vial containing 0.4 mg, 0.56 mg, or 1.2 mg of vosoritide per vial. A pre-filled syringe containing Sterile Water for Injection, USP for use as a diluent is also provided. The contents of each single dose vial are summarized by strength in Table 4. The product contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>69680-131-60</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-131-60) </PackageDescription>
<NDC11Code>69680-0131-60</NDC11Code>
<ProductNDC>69680-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210339</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.</IndicationAndUsage>
<Description>Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4.</Description>
</NDC>
<NDC>
<NDCCode>69680-132-60</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-132-60) </PackageDescription>
<NDC11Code>69680-0132-60</NDC11Code>
<ProductNDC>69680-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210339</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>425</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF.</IndicationAndUsage>
<Description>Propafenone hydrochloride extended-release capsules, USP is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2′-[2-hydroxy-3-(propylamino)propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone Hydrochloride, USP occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. Propafenone hydrochloride extended-release capsules, USP are filled with round 2 mm mini-tablets containing propafenone hydrochloride, USP and the following inactive ingredients: hypromellose, magnesium stearate, titanium dioxide, gelatin, shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, FD&C Blue 1 and FD&C Red 3 (225 mg and 325 mg only). The 225 mg and 325 mg capsule also contains FD&C Yellow No. 5 (tartrazine) as a color additive. Meets USP Dissolution Test #4.</Description>
</NDC>
<NDC>
<NDCCode>0781-3531-91</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3531-91) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00781-3531-91</NDC11Code>
<ProductNDC>0781-3531</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212700</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2 R,3 S)- N-benzoyl-3-phenylisoserine. The empirical formula is C 47H 51NO 14and the molecular weight is 853.92. Paclitaxel has the following structural formula:. Paclitaxel is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at approximately 213°C to 216°C. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single‑dose vial contains 100 mg of paclitaxel (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate). Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel formulated as albumin‑bound particles. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is free of solvents.</Description>
</NDC>
<NDC>
<NDCCode>52747-620-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX (52747-620-10) > 4 CAPSULE in 1 BLISTER PACK (52747-620-04) </PackageDescription>
<NDC11Code>52747-0620-10</NDC11Code>
<ProductNDC>52747-620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Concept Ob</ProprietaryName>
<NonProprietaryName>Vitamin Mineral Supplement</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>U.S. Pharmaceutical Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM; MANGANESE SULFATE; ZINC SULFATE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>42.5; 42.5; 210; 1; 5; 5; 20; 7; 25; 300; 10; 800; 6.9; 1.3; 18.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Concept OBTM is a prenatal supplement designed to improve the nutritional status for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept OBTM may also be used to improve the nutritional status of women before conception.</IndicationAndUsage>
<Description>DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .....................................130 mg (Equivalent to about 42.5 mg of Elemental Iron) PolysaccharideIronComplex .....................................92.4mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..................................... 210 mg Folic Acid ................................................................................... 1 mg Thiamine Mononitrate (B1)................................................. 5 mg Riboflavin (B2).......................................................................... 5 mg Niacin (B3)...............................................................................20 mg d-Calcium Pantothenate (B5)............................................. 7 mg Pyridoxine HCl (B6) ..............................................................25 mg Biotin (B7)........................................................................... 300 mcg Cyanocobalamin (B12) .....................................................10 mcg Copper (as Copper Sulfate)..........................................800 mcg Magnesium (as Magnesium Sulfate)............................6.9 mg Manganese (as Manganese Sulfate).............................1.3 mg Zinc (as Zinc Sulfate) ....................................................... 18.2 mg Inactive Ingredients: Hypromellose, Silicon Dioxide, Magnesium Stearate, Carmine, and Candurin Silver Fine.</Description>
</NDC>
<NDC>
<NDCCode>52747-620-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (52747-620-30) </PackageDescription>
<NDC11Code>52747-0620-30</NDC11Code>
<ProductNDC>52747-620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Concept Ob</ProprietaryName>
<NonProprietaryName>Vitamin Mineral Supplement</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>U.S. Pharmaceutical Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM; MANGANESE SULFATE; ZINC SULFATE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>42.5; 42.5; 210; 1; 5; 5; 20; 7; 25; 300; 10; 800; 6.9; 1.3; 18.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS: Concept OBTM is a prenatal supplement designed to improve the nutritional status for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept OBTM may also be used to improve the nutritional status of women before conception.</IndicationAndUsage>
<Description>DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .....................................130 mg (Equivalent to about 42.5 mg of Elemental Iron) PolysaccharideIronComplex .....................................92.4mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..................................... 210 mg Folic Acid ................................................................................... 1 mg Thiamine Mononitrate (B1)................................................. 5 mg Riboflavin (B2).......................................................................... 5 mg Niacin (B3)...............................................................................20 mg d-Calcium Pantothenate (B5)............................................. 7 mg Pyridoxine HCl (B6) ..............................................................25 mg Biotin (B7)........................................................................... 300 mcg Cyanocobalamin (B12) .....................................................10 mcg Copper (as Copper Sulfate)..........................................800 mcg Magnesium (as Magnesium Sulfate)............................6.9 mg Manganese (as Manganese Sulfate).............................1.3 mg Zinc (as Zinc Sulfate) ....................................................... 18.2 mg Inactive Ingredients: Hypromellose, Silicon Dioxide, Magnesium Stearate, Carmine, and Candurin Silver Fine.</Description>
</NDC>
<NDC>
<NDCCode>71093-130-01</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (71093-130-01) </PackageDescription>
<NDC11Code>71093-0130-01</NDC11Code>
<ProductNDC>71093-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076881</ApplicationNumber>
<LabelerName>ACI Healthcare USA, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Post-traumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.5 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2.HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white to off-white, crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline Hydrochloride Tablets for oral administration contain 27.98 mg, 55.96 mg and 111.92 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>71093-130-03</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (71093-130-03) </PackageDescription>
<NDC11Code>71093-0130-03</NDC11Code>
<ProductNDC>71093-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076881</ApplicationNumber>
<LabelerName>ACI Healthcare USA, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Post-traumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.5 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2.HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white to off-white, crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline Hydrochloride Tablets for oral administration contain 27.98 mg, 55.96 mg and 111.92 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>71093-130-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (71093-130-05) </PackageDescription>
<NDC11Code>71093-0130-05</NDC11Code>
<ProductNDC>71093-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076881</ApplicationNumber>
<LabelerName>ACI Healthcare USA, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Post-traumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.5 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2.HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white to off-white, crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline Hydrochloride Tablets for oral administration contain 27.98 mg, 55.96 mg and 111.92 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>78206-130-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (78206-130-01) / 1 CARTRIDGE in 1 KIT / .72 mL in 1 CARTRIDGE (78206-130-99) </PackageDescription>
<NDC11Code>78206-0130-01</NDC11Code>
<ProductNDC>78206-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>[iU]/.72mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>78206-130-59</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (78206-130-59) / 1 CARTRIDGE in 1 KIT / .72 mL in 1 CARTRIDGE (78206-130-58) </PackageDescription>
<NDC11Code>78206-0130-59</NDC11Code>
<ProductNDC>78206-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>[iU]/.72mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>69680-112-10</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (69680-112-10) / 1 mL in 1 VIAL (69680-112-01) </PackageDescription>
<NDC11Code>69680-0112-10</NDC11Code>
<ProductNDC>69680-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyanocobalamin</ProprietaryName>
<NonProprietaryName>Cyanocobalamin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209255</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.</IndicationAndUsage>
<Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative and Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>69680-112-25</NDCCode>
<PackageDescription>25 VIAL in 1 BOX (69680-112-25) / 1 mL in 1 VIAL (69680-112-01) </PackageDescription>
<NDC11Code>69680-0112-25</NDC11Code>
<ProductNDC>69680-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyanocobalamin</ProprietaryName>
<NonProprietaryName>Cyanocobalamin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209255</ApplicationNumber>
<LabelerName>Vitruvias Therapeutics</LabelerName>
<SubstanceName>CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 1 Addisonian (pernicious) anemia, 2 Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy, 3 Fish tapeworm infestation, 4 Malignancy of pancreas or bowel, 5 Folic acid deficiency.</IndicationAndUsage>
<Description>Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative and Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below.</Description>
</NDC>
</NDCList>