{
"NDC": [
{
"NDCCode": "54868-2207-3",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-3)",
"NDC11Code": "54868-2207-03",
"ProductNDC": "54868-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074587",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.",
"Description": "Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3."
},
{
"NDCCode": "0164-2207-66",
"PackageDescription": "3 g in 1 POUCH (0164-2207-66)",
"NDC11Code": "00164-2207-66",
"ProductNDC": "0164-2207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "White Mallow Diaper Rash Cream",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140822",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Weleda A.G. Schw�bisch Gm�nd, Zweigniederlassung der Weled",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "14",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses. Temporarily helps to relieve minor skin irritations due to diaper rash. Protects chafed skin from minor skin irritations, for sensitive skin. Helps protect from wetness that causes diaper rash."
},
{
"NDCCode": "37662-2207-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-2207-3) ",
"NDC11Code": "37662-2207-03",
"ProductNDC": "37662-2207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crataegus",
"NonProprietaryName": "Crataegus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "HAWTHORN LEAF WITH FLOWER",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221222",
"SamplePackage": "N"
},
{
"NDCCode": "50090-2207-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-2207-3) ",
"NDC11Code": "50090-2207-03",
"ProductNDC": "50090-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151030",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "54868-2207-0",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-0)",
"NDC11Code": "54868-2207-00",
"ProductNDC": "54868-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074587",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.",
"Description": "Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3."
},
{
"NDCCode": "54868-2207-2",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-2)",
"NDC11Code": "54868-2207-02",
"ProductNDC": "54868-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074587",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.",
"Description": "Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3."
},
{
"NDCCode": "54868-2207-5",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-5)",
"NDC11Code": "54868-2207-05",
"ProductNDC": "54868-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074587",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.",
"Description": "Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3."
},
{
"NDCCode": "54868-2207-6",
"PackageDescription": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-6)",
"NDC11Code": "54868-2207-06",
"ProductNDC": "54868-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074587",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.",
"Description": "Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3."
},
{
"NDCCode": "54868-2207-7",
"PackageDescription": "180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-7)",
"NDC11Code": "54868-2207-07",
"ProductNDC": "54868-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074587",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.",
"Description": "Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3."
},
{
"NDCCode": "0338-1005-02",
"PackageDescription": "18 BAG in 1 CARTON (0338-1005-02) / 250 mL in 1 BAG",
"NDC11Code": "00338-1005-02",
"ProductNDC": "0338-1005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride And Dextrose",
"NonProprietaryName": "Dopamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019615",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870327",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
"Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1005-03",
"PackageDescription": "12 BAG in 1 CARTON (0338-1005-03) / 500 mL in 1 BAG",
"NDC11Code": "00338-1005-03",
"ProductNDC": "0338-1005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride And Dextrose",
"NonProprietaryName": "Dopamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019615",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870327",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
"Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1007-02",
"PackageDescription": "18 BAG in 1 CARTON (0338-1007-02) / 250 mL in 1 BAG",
"NDC11Code": "00338-1007-02",
"ProductNDC": "0338-1007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride And Dextrose",
"NonProprietaryName": "Dopamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019615",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870327",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
"Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1007-03",
"PackageDescription": "12 BAG in 1 CARTON (0338-1007-03) / 500 mL in 1 BAG",
"NDC11Code": "00338-1007-03",
"ProductNDC": "0338-1007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride And Dextrose",
"NonProprietaryName": "Dopamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019615",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870327",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
"Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1009-02",
"PackageDescription": "18 BAG in 1 CARTON (0338-1009-02) / 250 mL in 1 BAG",
"NDC11Code": "00338-1009-02",
"ProductNDC": "0338-1009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dopamine Hydrochloride And Dextrose",
"NonProprietaryName": "Dopamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19870327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019615",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOPAMINE HYDROCHLORIDE",
"StrengthNumber": "320",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870327",
"SamplePackage": "N",
"IndicationAndUsage": "Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.",
"Description": "Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1073-02",
"PackageDescription": "18 BAG in 1 CARTON (0338-1073-02) / 250 mL in 1 BAG",
"NDC11Code": "00338-1073-02",
"ProductNDC": "0338-1073",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dobutamine Hydrochloride In Dextrose",
"NonProprietaryName": "Dobutamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19930927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020255",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930927",
"SamplePackage": "N",
"IndicationAndUsage": "Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
"Description": "Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). Viaflex containers, including Viaflex Plus containers, are made of flexible plastic and are for parenteral use. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1075-02",
"PackageDescription": "18 BAG in 1 CARTON (0338-1075-02) / 250 mL in 1 BAG",
"NDC11Code": "00338-1075-02",
"ProductNDC": "0338-1075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dobutamine Hydrochloride In Dextrose",
"NonProprietaryName": "Dobutamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19930927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020255",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930927",
"SamplePackage": "N",
"IndicationAndUsage": "Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
"Description": "Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). Viaflex containers, including Viaflex Plus containers, are made of flexible plastic and are for parenteral use. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-1077-02",
"PackageDescription": "18 BAG in 1 CARTON (0338-1077-02) / 250 mL in 1 BAG",
"NDC11Code": "00338-1077-02",
"ProductNDC": "0338-1077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dobutamine Hydrochloride In Dextrose",
"NonProprietaryName": "Dobutamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19930923",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020255",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930927",
"SamplePackage": "N",
"IndicationAndUsage": "Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
"Description": "Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). Viaflex containers, including Viaflex Plus containers, are made of flexible plastic and are for parenteral use. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "43742-2207-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-2207-1) ",
"NDC11Code": "43742-2207-01",
"ProductNDC": "43742-2207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chronagesic",
"NonProprietaryName": "Alpha-lipoicum Acidum, Apiolum, Arnica Montana, Cartilago Suis, Cinnamomum, Dulcamara, Funiculus Umbilicalis Suis, Nadidum, Natrum Oxalaceticum, Pantothenic Acid, Placenta Totalis Suis, Piper Nigrum, Rhus Tox, Sanguinaria Canadensis, Sulphur, Silicea, Symphytum Officinale, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20241108",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "ALPHA LIPOIC ACID; APIOLE (PARSLEY); ARNICA MONTANA WHOLE; SUS SCROFA CARTILAGE; CINNAMON; SOLANUM DULCAMARA TOP; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; PANTOTHENIC ACID; SUS SCROFA PLACENTA; GREEN PEPPERCORN; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; SILICON DIOXIDE; COMFREY ROOT; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "8; 16; 3; 8; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 8; 8; 12",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241108",
"SamplePackage": "N",
"IndicationAndUsage": " For the temporary relief of symptoms including. joint support joint pain joint stiffness. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "50090-2207-0",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (50090-2207-0) ",
"NDC11Code": "50090-2207-00",
"ProductNDC": "50090-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151030",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "50090-2207-1",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-2207-1) ",
"NDC11Code": "50090-2207-01",
"ProductNDC": "50090-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151030",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "50090-2207-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-2207-2) ",
"NDC11Code": "50090-2207-02",
"ProductNDC": "50090-2207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151030",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "50090-4562-0",
"PackageDescription": "250 mL in 1 BAG (50090-4562-0) ",
"NDC11Code": "50090-4562-00",
"ProductNDC": "50090-4562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dobutamine Hydrochloride In Dextrose",
"NonProprietaryName": "Dobutamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19930923",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020255",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190926",
"SamplePackage": "N",
"IndicationAndUsage": "Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
"Description": "Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX PLUS containers, are made of flexible plastic and are for parenteral use. VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "51662-1566-1",
"PackageDescription": "250 mL in 1 BAG (51662-1566-1) ",
"NDC11Code": "51662-1566-01",
"ProductNDC": "51662-1566",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dobutamine Hydrochloride",
"NonProprietaryName": "Dobutamine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210710",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020255",
"LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
"SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210710",
"SamplePackage": "N",
"IndicationAndUsage": "Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
"Description": "Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride, USP. (D-Glucopyranose monohydrate) Dextrose Hydrous, USP. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. * Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. † Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX PLUS containers, are made of flexible plastic and are for parenteral use. VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "55714-2207-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-2207-0)",
"NDC11Code": "55714-2207-00",
"ProductNDC": "55714-2207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fever - Infection",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium Perf., Ferrum Metallicum, Gelsemium, Hepar Sulph.calc., Iodium, Lachesis, Merc. Viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salix Nigra, Verbascum, Apis Mel., Echinacea, Hydrastis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-2207-1",
"PackageDescription": "28.35 g in 1 BOTTLE, GLASS (55714-2207-1)",
"NDC11Code": "55714-2207-01",
"ProductNDC": "55714-2207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fever - Infection",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium Perf., Ferrum Metallicum, Gelsemium, Hepar Sulph.calc., Iodium, Lachesis, Merc. Viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salix Nigra, Verbascum, Apis Mel., Echinacea, Hydrastis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-2207-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-2207-2)",
"NDC11Code": "55714-2207-02",
"ProductNDC": "55714-2207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fever - Infection",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium Perf., Ferrum Metallicum, Gelsemium, Hepar Sulph.calc., Iodium, Lachesis, Merc. Viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salix Nigra, Verbascum, Apis Mel., Echinacea, Hydrastis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "54868-0018-3",
"PackageDescription": "20 TABLET in 1 BOTTLE (54868-0018-3)",
"NDC11Code": "54868-0018-03",
"ProductNDC": "54868-0018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061904",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
},
{
"NDCCode": "54868-0021-3",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (54868-0021-3)",
"NDC11Code": "54868-0021-03",
"ProductNDC": "54868-0021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54868-0023-3",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (54868-0023-3)",
"NDC11Code": "54868-0023-03",
"ProductNDC": "54868-0023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19930611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062031",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-02-19"
},
{
"NDCCode": "54868-0024-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-0024-3)",
"NDC11Code": "54868-0024-03",
"ProductNDC": "54868-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
}
]
}
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<NDCList>
<NDC>
<NDCCode>54868-2207-3</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-3)</PackageDescription>
<NDC11Code>54868-2207-03</NDC11Code>
<ProductNDC>54868-2207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074587</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>0164-2207-66</NDCCode>
<PackageDescription>3 g in 1 POUCH (0164-2207-66)</PackageDescription>
<NDC11Code>00164-2207-66</NDC11Code>
<ProductNDC>0164-2207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>White Mallow Diaper Rash Cream</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140822</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Weleda A.G. Schw�bisch Gm�nd, Zweigniederlassung der Weled</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. Temporarily helps to relieve minor skin irritations due to diaper rash. Protects chafed skin from minor skin irritations, for sensitive skin. Helps protect from wetness that causes diaper rash.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-2207-3</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-2207-3) </PackageDescription>
<NDC11Code>37662-2207-03</NDC11Code>
<ProductNDC>37662-2207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crataegus</ProprietaryName>
<NonProprietaryName>Crataegus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>HAWTHORN LEAF WITH FLOWER</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-2207-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-2207-3) </PackageDescription>
<NDC11Code>50090-2207-03</NDC11Code>
<ProductNDC>50090-2207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>54868-2207-0</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-0)</PackageDescription>
<NDC11Code>54868-2207-00</NDC11Code>
<ProductNDC>54868-2207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074587</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>54868-2207-2</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-2)</PackageDescription>
<NDC11Code>54868-2207-02</NDC11Code>
<ProductNDC>54868-2207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074587</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>54868-2207-5</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-5)</PackageDescription>
<NDC11Code>54868-2207-05</NDC11Code>
<ProductNDC>54868-2207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074587</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>54868-2207-6</NDCCode>
<PackageDescription>10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-6)</PackageDescription>
<NDC11Code>54868-2207-06</NDC11Code>
<ProductNDC>54868-2207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074587</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>54868-2207-7</NDCCode>
<PackageDescription>180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-2207-7)</PackageDescription>
<NDC11Code>54868-2207-07</NDC11Code>
<ProductNDC>54868-2207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074587</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.</IndicationAndUsage>
<Description>Verapamil hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil hydrochloride is given below. (±)-5-[(3,4-Dimethoxyphenethyl)methylamino]-2-(3,4-dimethoxyphenyl)-2-isopropylvaleronitrile monohydrochloride. Verapamil hydrochloride, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil hydrochloride is not chemically related to other cardioactive drugs. Each extended-release tablet, for oral administration, contains 120 mg, 180 mg or 240 mg of verapamil hydrochloride. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium alginate, sodium lauryl sulfate, talc, and titanium dioxide. Verapamil Hydrochloride Extended-release Tablets USP, 120 mg meet USP Dissolution Test 1. Verapamil Hydrochloride Extended-release Tablets USP, 180 mg and 240 mg meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>0338-1005-02</NDCCode>
<PackageDescription>18 BAG in 1 CARTON (0338-1005-02) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-1005-02</NDC11Code>
<ProductNDC>0338-1005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName>
<NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870327</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019615</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
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<IndicationAndUsage>Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.</IndicationAndUsage>
<Description>Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-1005-03</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0338-1005-03) / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-1005-03</NDC11Code>
<ProductNDC>0338-1005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019615</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
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<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
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<IndicationAndUsage>Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.</IndicationAndUsage>
<Description>Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-1007-02</NDCCode>
<PackageDescription>18 BAG in 1 CARTON (0338-1007-02) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-1007-02</NDC11Code>
<ProductNDC>0338-1007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019615</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
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<IndicationAndUsage>Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.</IndicationAndUsage>
<Description>Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-1007-03</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0338-1007-03) / 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-1007-03</NDC11Code>
<ProductNDC>0338-1007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19870327</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019615</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
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<IndicationAndUsage>Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.</IndicationAndUsage>
<Description>Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-1009-02</NDCCode>
<PackageDescription>18 BAG in 1 CARTON (0338-1009-02) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-1009-02</NDC11Code>
<ProductNDC>0338-1009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dopamine Hydrochloride And Dextrose</ProprietaryName>
<NonProprietaryName>Dopamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019615</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DOPAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis.</IndicationAndUsage>
<Description>Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection. Structural formulas are shown below. Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The solution provides a caloric content of 170 kcal/L. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition and osmolarity are given below. 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 800 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L (calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 1600 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose Injection, USP provides 3200 mcg/mL Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 286 mOsmol/L (calc). Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output. Dopamine hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus containers, are made of flexible plastic and are for parenteral use. VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-1073-02</NDCCode>
<PackageDescription>18 BAG in 1 CARTON (0338-1073-02) / 250 mL in 1 BAG</PackageDescription>
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<ProductNDC>0338-1073</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dobutamine Hydrochloride In Dextrose</ProprietaryName>
<NonProprietaryName>Dobutamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19930927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020255</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
<Description>Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). Viaflex containers, including Viaflex Plus containers, are made of flexible plastic and are for parenteral use. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-1075-02</NDCCode>
<PackageDescription>18 BAG in 1 CARTON (0338-1075-02) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-1075-02</NDC11Code>
<ProductNDC>0338-1075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dobutamine Hydrochloride In Dextrose</ProprietaryName>
<NonProprietaryName>Dobutamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19930927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020255</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
<Description>Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). Viaflex containers, including Viaflex Plus containers, are made of flexible plastic and are for parenteral use. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
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<ApplicationNumber>NDA020255</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
<Description>Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). Viaflex containers, including Viaflex Plus containers, are made of flexible plastic and are for parenteral use. Viaflex Plus on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
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<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-2207-1) </PackageDescription>
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<NonProprietaryName>Alpha-lipoicum Acidum, Apiolum, Arnica Montana, Cartilago Suis, Cinnamomum, Dulcamara, Funiculus Umbilicalis Suis, Nadidum, Natrum Oxalaceticum, Pantothenic Acid, Placenta Totalis Suis, Piper Nigrum, Rhus Tox, Sanguinaria Canadensis, Sulphur, Silicea, Symphytum Officinale, Thuja Occidentalis</NonProprietaryName>
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<SubstanceName>ALPHA LIPOIC ACID; APIOLE (PARSLEY); ARNICA MONTANA WHOLE; SUS SCROFA CARTILAGE; CINNAMON; SOLANUM DULCAMARA TOP; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; PANTOTHENIC ACID; SUS SCROFA PLACENTA; GREEN PEPPERCORN; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; SILICON DIOXIDE; COMFREY ROOT; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
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<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
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<LastUpdate>2024-11-13</LastUpdate>
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<IndicationAndUsage> For the temporary relief of symptoms including. joint support joint pain joint stiffness. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
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<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (50090-2207-0) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
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<LabelerName>A-S Medication Solutions</LabelerName>
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<StrengthNumber>25</StrengthNumber>
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<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
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<LastUpdate>2024-10-04</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
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<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-2207-2) </PackageDescription>
<NDC11Code>50090-2207-02</NDC11Code>
<ProductNDC>50090-2207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
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<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020255</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DOBUTAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
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<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
<Description>Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX PLUS containers, are made of flexible plastic and are for parenteral use. VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
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<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.</IndicationAndUsage>
<Description>Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride, USP. (D-Glucopyranose monohydrate) Dextrose Hydrous, USP. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. * Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. † Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX PLUS containers, are made of flexible plastic and are for parenteral use. VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
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<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-2207-0)</PackageDescription>
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<ProprietaryName>Fever - Infection</ProprietaryName>
<NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium Perf., Ferrum Metallicum, Gelsemium, Hepar Sulph.calc., Iodium, Lachesis, Merc. Viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salix Nigra, Verbascum, Apis Mel., Echinacea, Hydrastis</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-2207-1</NDCCode>
<PackageDescription>28.35 g in 1 BOTTLE, GLASS (55714-2207-1)</PackageDescription>
<NDC11Code>55714-2207-01</NDC11Code>
<ProductNDC>55714-2207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fever - Infection</ProprietaryName>
<NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium Perf., Ferrum Metallicum, Gelsemium, Hepar Sulph.calc., Iodium, Lachesis, Merc. Viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salix Nigra, Verbascum, Apis Mel., Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-2207-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-2207-2)</PackageDescription>
<NDC11Code>55714-2207-02</NDC11Code>
<ProductNDC>55714-2207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fever - Infection</ProprietaryName>
<NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum Nap., Antimon. Tart., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium Perf., Ferrum Metallicum, Gelsemium, Hepar Sulph.calc., Iodium, Lachesis, Merc. Viv., Phosphorus, Pulsatilla, Rhus Toxicodendron, Salix Nigra, Verbascum, Apis Mel., Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0018-3</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (54868-0018-3)</PackageDescription>
<NDC11Code>54868-0018-03</NDC11Code>
<ProductNDC>54868-0018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061904</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate.</Description>
</NDC>
<NDC>
<NDCCode>54868-0021-3</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (54868-0021-3)</PackageDescription>
<NDC11Code>54868-0021-03</NDC11Code>
<ProductNDC>54868-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54868-0023-3</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (54868-0023-3)</PackageDescription>
<NDC11Code>54868-0023-03</NDC11Code>
<ProductNDC>54868-0023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062031</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-02-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>54868-0024-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (54868-0024-3)</PackageDescription>
<NDC11Code>54868-0024-03</NDC11Code>
<ProductNDC>54868-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.</Description>
</NDC>
</NDCList>