{
"NDC": [
{
"NDCCode": "10544-958-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-958-21)",
"NDC11Code": "10544-0958-21",
"ProductNDC": "10544-958",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Blenheim Pharmacal, Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5) .",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum."
},
{
"NDCCode": "10544-958-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (10544-958-20)",
"NDC11Code": "10544-0958-20",
"ProductNDC": "10544-958",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Blenheim Pharmacal, Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5) .",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum."
},
{
"NDCCode": "10544-958-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (10544-958-30)",
"NDC11Code": "10544-0958-30",
"ProductNDC": "10544-958",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Blenheim Pharmacal, Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5) .",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum."
},
{
"NDCCode": "10544-958-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (10544-958-60)",
"NDC11Code": "10544-0958-60",
"ProductNDC": "10544-958",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Blenheim Pharmacal, Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5) .",
"Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum."
},
{
"NDCCode": "11673-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (11673-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "11673-0958-21",
"ProductNDC": "11673-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Cough Suppressant Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Target Corporation",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "21130-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "21130-0958-21",
"ProductNDC": "21130-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Safeway",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "30142-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "30142-0958-21",
"ProductNDC": "30142-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Kroger Company",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130815",
"SamplePackage": "N"
},
{
"NDCCode": "36800-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (36800-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "36800-0958-21",
"ProductNDC": "36800-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130822",
"EndMarketingDate": "20220401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130827",
"EndMarketingDatePackage": "20220401",
"SamplePackage": "N"
},
{
"NDCCode": "41163-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (41163-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "41163-0958-21",
"ProductNDC": "41163-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Supervalu Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130715",
"SamplePackage": "N"
},
{
"NDCCode": "41250-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (41250-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "41250-0958-21",
"ProductNDC": "41250-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "41520-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (41520-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "41520-0958-21",
"ProductNDC": "41520-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "American Sales Company",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2019-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130823",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep."
},
{
"NDCCode": "42507-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (42507-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "42507-0958-21",
"ProductNDC": "42507-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130708",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "HyVee Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130708",
"SamplePackage": "N"
},
{
"NDCCode": "49348-958-21",
"PackageDescription": "150 TABLET, CHEWABLE in 1 BOTTLE (49348-958-21)",
"NDC11Code": "49348-0958-21",
"ProductNDC": "49348-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Calcium Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20110401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "McKesson",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "49738-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (49738-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "49738-0958-21",
"ProductNDC": "49738-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Sense Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Kmart Corporation",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130805",
"SamplePackage": "N"
},
{
"NDCCode": "55312-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (55312-958-21) > 89 mL in 1 BOTTLE",
"NDC11Code": "55312-0958-21",
"ProductNDC": "55312-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "12 Hour Cough Relief",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Western Family Foods Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "55910-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (55910-958-21) / 89 mL in 1 BOTTLE",
"NDC11Code": "55910-0958-21",
"ProductNDC": "55910-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Health Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "Dolgencorp, LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130710",
"SamplePackage": "N"
},
{
"NDCCode": "59779-958-21",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-958-21) / 89 mL in 1 BOTTLE",
"NDC11Code": "59779-0958-21",
"ProductNDC": "59779-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough Dm",
"NonProprietaryName": "Dextromethorphan Polistirex",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20130716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091135",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130716",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep."
},
{
"NDCCode": "70675-958-21",
"PackageDescription": "75 mL in 1 BOTTLE (70675-958-21) ",
"NDC11Code": "70675-0958-21",
"ProductNDC": "70675-958",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Deqing Jiarou Daily Chemical Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170116",
"SamplePackage": "N",
"IndicationAndUsage": " Decreases Bacteria on Hands."
},
{
"NDCCode": "72551-246-04",
"PackageDescription": "958.21 g in 1 BOTTLE (72551-246-04) ",
"NDC11Code": "72551-0246-04",
"ProductNDC": "72551-246",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Therabreath Healthy Smile Oral Rinse",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20181002",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Dr. Harold Katz, LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".0005",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20181002",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "72551-247-06",
"PackageDescription": "958.21 g in 1 BOTTLE (72551-247-06) ",
"NDC11Code": "72551-0247-06",
"ProductNDC": "72551-247",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Therabreath Healthy Gums Oral Rinse",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Dr. Harold Katz, LLC",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": ".0005",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent gingivitis, an early form of gum disease and bleeding gum Helps control plaque that leads to gingivitis and bleeding gums."
},
{
"NDCCode": "10544-007-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-007-21)",
"NDC11Code": "10544-0007-21",
"ProductNDC": "10544-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100720",
"EndMarketingDate": "20190228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-03-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "10544-018-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-018-21)",
"NDC11Code": "10544-0018-21",
"ProductNDC": "10544-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100917",
"EndMarketingDate": "20171031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "10544-057-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-057-21)",
"NDC11Code": "10544-0057-21",
"ProductNDC": "10544-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120627",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062791",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalisSkin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenesBone infections caused by Staphylococcus aureus and/or Proteus mirabilisGenitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniaeNote — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP 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.",
"Description": "Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin, USP has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D‑phenylglycyl group as substituent at the 7‑amino position and an unsubstituted methyl group at the 3‑position. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate; capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water."
},
{
"NDCCode": "10544-072-21",
"PackageDescription": "21 TABLET, FILM COATED in 1 BOTTLE (10544-072-21)",
"NDC11Code": "10544-0072-21",
"ProductNDC": "10544-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071611",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. C20H21NHCl M.W. 311.9. Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "10544-082-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-082-21)",
"NDC11Code": "10544-0082-21",
"ProductNDC": "10544-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062713",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules 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.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide."
},
{
"NDCCode": "10544-083-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-083-21)",
"NDC11Code": "10544-0083-21",
"ProductNDC": "10544-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091276",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin capsules have been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease., 2 Moderate to severe ankylosing spondylitis., 3 Moderate to severe osteoarthritis., 4 Acute painful shoulder (bursitis and/or tendinitis)., 5 Acute gouty arthritis.",
"Description": "Indomethacin capsules, USP for oral administration are provided in two dosage strengths which contain either 25 mg or 50 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H -indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Indomethacin, USP is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. Each capsule for oral administration contains 25 mg or 50 mg of indomethacin and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1, D&C Yellow No. 10, gelatin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. The imprinting ink contains the following: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "10544-096-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-096-21)",
"NDC11Code": "10544-0096-21",
"ProductNDC": "10544-096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062058",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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. Indicated surgical procedures should be performed.",
"Description": "Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red. No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin."
},
{
"NDCCode": "10544-098-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-098-21)",
"NDC11Code": "10544-0098-21",
"ProductNDC": "10544-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130311",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087022",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m 2, or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "10544-099-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (10544-099-21)",
"NDC11Code": "10544-0099-21",
"ProductNDC": "10544-099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040886",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m 2, or≥27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [ see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine Hydrochloride USP has the chemical name of α, α -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine Hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red #3, FD&C Red #40, titanium dioxide and the 30 mg capsules contain D&C Yellow #10, FD&C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&C blue #1/Brilliant blue FCF Aluminum Lake, D&C red #28 and gelatin."
},
{
"NDCCode": "10544-116-21",
"PackageDescription": "21 TABLET in 1 BOTTLE (10544-116-21)",
"NDC11Code": "10544-0116-21",
"ProductNDC": "10544-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040876",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Phentermine hydrochloride, USP 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride USP has the chemical name of α, α -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an sympathomimetic amine anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients corn starch, D&C Red #33, FD&C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients corn starch, FD&C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, stearic acid, and sucrose."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>10544-958-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-958-21)</PackageDescription>
<NDC11Code>10544-0958-21</NDC11Code>
<ProductNDC>10544-958</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
</NDC>
<NDC>
<NDCCode>10544-958-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (10544-958-20)</PackageDescription>
<NDC11Code>10544-0958-20</NDC11Code>
<ProductNDC>10544-958</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
</NDC>
<NDC>
<NDCCode>10544-958-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (10544-958-30)</PackageDescription>
<NDC11Code>10544-0958-30</NDC11Code>
<ProductNDC>10544-958</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
</NDC>
<NDC>
<NDCCode>10544-958-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (10544-958-60)</PackageDescription>
<NDC11Code>10544-0958-60</NDC11Code>
<ProductNDC>10544-958</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5) .</IndicationAndUsage>
<Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
</NDC>
<NDC>
<NDCCode>11673-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0958-21</NDC11Code>
<ProductNDC>11673-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Cough Suppressant Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>21130-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0958-21</NDC11Code>
<ProductNDC>21130-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>30142-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0958-21</NDC11Code>
<ProductNDC>30142-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36800-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (36800-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>36800-0958-21</NDC11Code>
<ProductNDC>36800-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130822</StartMarketingDate>
<EndMarketingDate>20220401</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130827</StartMarketingDatePackage>
<EndMarketingDatePackage>20220401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41163-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41163-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41163-0958-21</NDC11Code>
<ProductNDC>41163-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Supervalu Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41250-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41250-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0958-21</NDC11Code>
<ProductNDC>41250-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41520-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41520-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41520-0958-21</NDC11Code>
<ProductNDC>41520-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42507-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42507-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>42507-0958-21</NDC11Code>
<ProductNDC>42507-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130708</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>HyVee Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130708</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49348-958-21</NDCCode>
<PackageDescription>150 TABLET, CHEWABLE in 1 BOTTLE (49348-958-21)</PackageDescription>
<NDC11Code>49348-0958-21</NDC11Code>
<ProductNDC>49348-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunmark Calcium Antacid</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>McKesson</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49738-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49738-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49738-0958-21</NDC11Code>
<ProductNDC>49738-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Sense Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Kmart Corporation</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55312-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55312-958-21) > 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55312-0958-21</NDC11Code>
<ProductNDC>55312-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>12 Hour Cough Relief</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Western Family Foods Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>55910-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55910-958-21) / 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55910-0958-21</NDC11Code>
<ProductNDC>55910-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dg Health Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>Dolgencorp, LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59779-958-21</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59779-958-21) / 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0958-21</NDC11Code>
<ProductNDC>59779-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Polistirex</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091135</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70675-958-21</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (70675-958-21) </PackageDescription>
<NDC11Code>70675-0958-21</NDC11Code>
<ProductNDC>70675-958</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Deqing Jiarou Daily Chemical Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Decreases Bacteria on Hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72551-246-04</NDCCode>
<PackageDescription>958.21 g in 1 BOTTLE (72551-246-04) </PackageDescription>
<NDC11Code>72551-0246-04</NDC11Code>
<ProductNDC>72551-246</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Therabreath Healthy Smile Oral Rinse</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181002</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Dr. Harold Katz, LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.0005</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72551-247-06</NDCCode>
<PackageDescription>958.21 g in 1 BOTTLE (72551-247-06) </PackageDescription>
<NDC11Code>72551-0247-06</NDC11Code>
<ProductNDC>72551-247</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Therabreath Healthy Gums Oral Rinse</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Dr. Harold Katz, LLC</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.0005</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent gingivitis, an early form of gum disease and bleeding gum Helps control plaque that leads to gingivitis and bleeding gums.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10544-007-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-007-21)</PackageDescription>
<NDC11Code>10544-0007-21</NDC11Code>
<ProductNDC>10544-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100720</StartMarketingDate>
<EndMarketingDate>20190228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>10544-018-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-018-21)</PackageDescription>
<NDC11Code>10544-0018-21</NDC11Code>
<ProductNDC>10544-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100917</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>10544-057-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-057-21)</PackageDescription>
<NDC11Code>10544-0057-21</NDC11Code>
<ProductNDC>10544-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120627</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062791</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalisSkin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenesBone infections caused by Staphylococcus aureus and/or Proteus mirabilisGenitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniaeNote — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP 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.</IndicationAndUsage>
<Description>Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin, USP has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D‑phenylglycyl group as substituent at the 7‑amino position and an unsubstituted methyl group at the 3‑position. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate; capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water.</Description>
</NDC>
<NDC>
<NDCCode>10544-072-21</NDCCode>
<PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (10544-072-21)</PackageDescription>
<NDC11Code>10544-0072-21</NDC11Code>
<ProductNDC>10544-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071611</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. C20H21NHCl M.W. 311.9. Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10544-082-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-082-21)</PackageDescription>
<NDC11Code>10544-0082-21</NDC11Code>
<ProductNDC>10544-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062713</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules 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.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4SH 2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The capsules also contain anhydrous lactose, gelatin, magnesium stearate, talc and titanium dioxide. The capsules are imprinted with edible ink containing black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>10544-083-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-083-21)</PackageDescription>
<NDC11Code>10544-0083-21</NDC11Code>
<ProductNDC>10544-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091276</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin capsules have been found effective in active stages of the following: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease., 2 Moderate to severe ankylosing spondylitis., 3 Moderate to severe osteoarthritis., 4 Acute painful shoulder (bursitis and/or tendinitis)., 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin capsules, USP for oral administration are provided in two dosage strengths which contain either 25 mg or 50 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H -indole-3-acetic acid. The structural formula is. C19H16ClNO4 M.W. 357.79. Indomethacin, USP is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. Each capsule for oral administration contains 25 mg or 50 mg of indomethacin and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1, D&C Yellow No. 10, gelatin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. The imprinting ink contains the following: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>10544-096-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-096-21)</PackageDescription>
<NDC11Code>10544-0096-21</NDC11Code>
<ProductNDC>10544-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062058</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below. Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Triple Therapy. Amoxicillin/Clarithromycin/Lansoprazole. Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). Dual Therapy. Amoxicillin/Lansoprazole. Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.). To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Formulations of amoxicillin capsules, USP contain amoxicillin, a semi-synthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S∙3H2O, and the molecular weight is 419.45. Capsules of Amoxicillin are intended for oral administration. Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. Each 250 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red. No. 3, titanium dioxide and gelatin. Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. Each 500 mg capsule contains the following inactive ingredients: magnesium stearate, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide and gelatin.</Description>
</NDC>
<NDC>
<NDCCode>10544-098-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-098-21)</PackageDescription>
<NDC11Code>10544-0098-21</NDC11Code>
<ProductNDC>10544-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130311</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087022</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m 2, or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>10544-099-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (10544-099-21)</PackageDescription>
<NDC11Code>10544-0099-21</NDC11Code>
<ProductNDC>10544-099</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040886</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m 2, or≥27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [ see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine Hydrochloride USP has the chemical name of α, α -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine Hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red #3, FD&C Red #40, titanium dioxide and the 30 mg capsules contain D&C Yellow #10, FD&C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&C blue #1/Brilliant blue FCF Aluminum Lake, D&C red #28 and gelatin.</Description>
</NDC>
<NDC>
<NDCCode>10544-116-21</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (10544-116-21)</PackageDescription>
<NDC11Code>10544-0116-21</NDC11Code>
<ProductNDC>10544-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040876</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride USP has the chemical name of α, α -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an sympathomimetic amine anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride capsules, USP contain the inactive ingredients corn starch, D&C Red #33, FD&C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide. Phentermine hydrochloride tablets, USP contain the inactive ingredients corn starch, FD&C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, stearic acid, and sucrose.</Description>
</NDC>
</NDCList>