{
"NDC": [
{
"NDCCode": "42571-322-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-60) ",
"NDC11Code": "42571-0322-60",
"ProductNDC": "42571-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-322-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-30) ",
"NDC11Code": "42571-0322-30",
"ProductNDC": "42571-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-322-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-90) ",
"NDC11Code": "42571-0322-90",
"ProductNDC": "42571-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "16590-322-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (16590-322-60)",
"NDC11Code": "16590-0322-60",
"ProductNDC": "16590-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078406",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "35573-322-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (35573-322-60)",
"NDC11Code": "35573-0322-60",
"ProductNDC": "35573-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Relhist Dmx",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "BUREL PHARMACEUTICALS, INC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "15; 380; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "42254-322-60",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (42254-322-60) > 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "42254-0322-60",
"ProductNDC": "42254-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064042",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Polyene Antifungal [EPC],Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Nystatin oral suspension, USP is indicated for the treatment of infections of the oral cavity caused by Candida albicans.",
"Description": "Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. Its structural formula is. C47H75NO17 M.W. 926.13. Nystatin oral suspension, USP is a cherry-mint flavored, ready-to-use suspension. Each mL of nystatin oral suspension, USP contains 100,000 units of nystatin in a vehicle containing 50% w/v sucrose with the following inactive ingredients: alcohol (less than 1% v/v), carboxymethylcellulose sodium, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, and sodium citrate. Citric acid and/or sodium hydroxide may be used to adjust pH (5.3-7.5). PRESERVATIVES ADDED: Methylparaben 0.12%, Propylparaben 0.03%."
},
{
"NDCCode": "43598-322-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-322-60) ",
"NDC11Code": "43598-0322-60",
"ProductNDC": "43598-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203874",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.",
"Description": "Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium."
},
{
"NDCCode": "43744-322-60",
"PackageDescription": "750 g in 1 DRUM (43744-322-60)",
"NDC11Code": "43744-0322-60",
"ProductNDC": "43744-322",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Doxapram Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120404",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "DOXAPRAM HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "47335-322-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (47335-322-86) ",
"NDC11Code": "47335-0322-86",
"ProductNDC": "47335-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090058",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150711",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride tablets, USP are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, talc, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, talc, iron oxide red, yellow iron oxide, and FD&C yellow #6 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol, talc and black iron oxide (10 mg tablets)."
},
{
"NDCCode": "47993-322-01",
"PackageDescription": "60 mL in 1 BOTTLE (47993-322-01) ",
"NDC11Code": "47993-0322-01",
"ProductNDC": "47993-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201210",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201210",
"SamplePackage": "N"
},
{
"NDCCode": "50563-324-01",
"PackageDescription": "1 KIT in 1 KIT (50563-324-01) * 60 mL in 1 BOTTLE (50563-322-01) * 60 mL in 1 BOTTLE (50563-323-01) * 60 mL in 1 BOTTLE (50563-321-01) ",
"NDC11Code": "50563-0324-01",
"ProductNDC": "50563-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beauty Concepts Antibacterial Hand Sanitizer Trio Winter Mint Unscented Frosted Berry",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20201009",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ENCHANTE ACCESSORIES INC.",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201009",
"SamplePackage": "N"
},
{
"NDCCode": "51655-322-25",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-322-25) ",
"NDC11Code": "51655-0322-25",
"ProductNDC": "51655-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209603",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230425",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha 1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula:. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "55292-322-60",
"PackageDescription": "60 TABLET, COATED in 1 BLISTER PACK (55292-322-60) ",
"NDC11Code": "55292-0322-60",
"ProductNDC": "55292-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isturisa",
"NonProprietaryName": "Osilodrostat",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212801",
"LabelerName": "Recordati Rare Diseases, Inc.",
"SubstanceName": "OSILODROSTAT PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cortisol Synthesis Inhibitor [EPC], Cytochrome P450 11B1 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N"
},
{
"NDCCode": "55700-322-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55700-322-60)",
"NDC11Code": "55700-0322-60",
"ProductNDC": "55700-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078251",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "3.125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "56062-322-16",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (56062-322-16) / 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "56062-0322-16",
"ProductNDC": "56062-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075598",
"LabelerName": "Publix Super Markets Inc",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210525",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)."
},
{
"NDCCode": "60760-322-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (60760-322-60)",
"NDC11Code": "60760-0322-60",
"ProductNDC": "60760-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kadian Er",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101221",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020616",
"LabelerName": "St Marys Medical Park Pharmacy",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63187-322-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (63187-322-60) ",
"NDC11Code": "63187-0322-60",
"ProductNDC": "63187-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19920701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073553",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "63874-322-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (63874-322-60)",
"NDC11Code": "63874-0322-60",
"ProductNDC": "63874-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "Altura Pharmaceuticals, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"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 Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "64796-322-11",
"PackageDescription": "60 TABLET, CHEWABLE in 1 BOX (64796-322-11) ",
"NDC11Code": "64796-0322-11",
"ProductNDC": "64796-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindfill",
"NonProprietaryName": "Cinnamon Toothpaste Tablets",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "DENTAL",
"StartMarketingDate": "20230105",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Identipak, Inc",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".62",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230105",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "66267-322-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (66267-322-60) ",
"NDC11Code": "66267-0322-60",
"ProductNDC": "66267-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203126",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161109",
"SamplePackage": "N"
},
{
"NDCCode": "69343-322-60",
"PackageDescription": "6 CANISTER in 1 CARTON (69343-322-60) > 1 CLOTH in 1 CANISTER",
"NDC11Code": "69343-0322-60",
"ProductNDC": "69343-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Elyptol Hand Sanitizer Wipe",
"NonProprietaryName": "Ethanol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Elyptol Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "1/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170801",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on skin. Recommended for repeated use."
},
{
"NDCCode": "72189-322-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (72189-322-60) ",
"NDC11Code": "72189-0322-60",
"ProductNDC": "72189-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070322",
"LabelerName": "Direct Rx",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220211",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol hydrochloride tablets, USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol hydrochloride tablets, USP are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol hydrochloride tablets, USP are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol hydrochloride tablets, USP are not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol hydrochloride tablets, USP improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol hydrochloride tablets, USP are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. [chemical-structure]. C16H21NO2HCl M.W. 295.80. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Propranolol hydrochloride tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol hydrochloride tablets, USP also contain colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (40 mg and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg)."
},
{
"NDCCode": "75448-322-01",
"PackageDescription": "60 mL in 1 BOTTLE (75448-322-01) ",
"NDC11Code": "75448-0322-01",
"ProductNDC": "75448-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thrive Health Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200429",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Sanrace Biotechnology Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "76282-322-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (76282-322-60) ",
"NDC11Code": "76282-0322-60",
"ProductNDC": "76282-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "Exelan Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20130320",
"SamplePackage": "N"
},
{
"NDCCode": "76420-322-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (76420-322-60) ",
"NDC11Code": "76420-0322-60",
"ProductNDC": "76420-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207419",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250415",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see Warnings], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):. : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains: Oxycodone hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. Inactive Ingredients The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.17. It may be represented by the following structural formula:."
},
{
"NDCCode": "80487-322-11",
"PackageDescription": "60 TABLET, CHEWABLE in 1 BOX (80487-322-11) ",
"NDC11Code": "80487-0322-11",
"ProductNDC": "80487-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindfill",
"NonProprietaryName": "Cinnamon Toothpaste Tablets",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "DENTAL",
"StartMarketingDate": "20230105",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "By Humankind Inc",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".62",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230105",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "83013-322-01",
"PackageDescription": "60 g in 1 BOTTLE, PUMP (83013-322-01) ",
"NDC11Code": "83013-0322-01",
"ProductNDC": "83013-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hismile",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL",
"RouteName": "DENTAL",
"StartMarketingDate": "20240715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "HISMILE PTY LTD",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".243",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "83013-322-06",
"PackageDescription": "60 g in 1 BOTTLE, PUMP (83013-322-06) ",
"NDC11Code": "83013-0322-06",
"ProductNDC": "83013-322",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hismile",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL",
"RouteName": "DENTAL",
"StartMarketingDate": "20240715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "HISMILE PTY LTD",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".243",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "87063-322-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (87063-322-60) ",
"NDC11Code": "87063-0322-60",
"ProductNDC": "87063-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202180",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260509",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone hydrochloride tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1).",
"Description": "Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula:C 19H 22ClN 5O · HCl. Molecular Weight:408.33. Each tablet, for oral administration, contains 50 mg, 100 mg, or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, sodium lauryl sulfate, and sodium starch glycolate."
},
{
"NDCCode": "42571-005-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42571-005-60) ",
"NDC11Code": "42571-0005-60",
"ProductNDC": "42571-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090383",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
}
]
}
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<NDCCode>42571-322-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-60) </PackageDescription>
<NDC11Code>42571-0322-60</NDC11Code>
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<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<NDCCode>42571-322-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-30) </PackageDescription>
<NDC11Code>42571-0322-30</NDC11Code>
<ProductNDC>42571-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211466</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>42571-322-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-90) </PackageDescription>
<NDC11Code>42571-0322-90</NDC11Code>
<ProductNDC>42571-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211466</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-322-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (16590-322-60)</PackageDescription>
<NDC11Code>16590-0322-60</NDC11Code>
<ProductNDC>16590-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078406</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>35573-322-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (35573-322-60)</PackageDescription>
<NDC11Code>35573-0322-60</NDC11Code>
<ProductNDC>35573-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Relhist Dmx</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>BUREL PHARMACEUTICALS, INC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 380; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42254-322-60</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (42254-322-60) > 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>42254-0322-60</NDC11Code>
<ProductNDC>42254-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064042</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC],Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nystatin oral suspension, USP is indicated for the treatment of infections of the oral cavity caused by Candida albicans.</IndicationAndUsage>
<Description>Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. Its structural formula is. C47H75NO17 M.W. 926.13. Nystatin oral suspension, USP is a cherry-mint flavored, ready-to-use suspension. Each mL of nystatin oral suspension, USP contains 100,000 units of nystatin in a vehicle containing 50% w/v sucrose with the following inactive ingredients: alcohol (less than 1% v/v), carboxymethylcellulose sodium, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, and sodium citrate. Citric acid and/or sodium hydroxide may be used to adjust pH (5.3-7.5). PRESERVATIVES ADDED: Methylparaben 0.12%, Propylparaben 0.03%.</Description>
</NDC>
<NDC>
<NDCCode>43598-322-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-322-60) </PackageDescription>
<NDC11Code>43598-0322-60</NDC11Code>
<ProductNDC>43598-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203874</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate and atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine.</IndicationAndUsage>
<Description>Amlodipine besylate and atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate USP with the HMG CoA-reductase inhibitor atorvastatin calcium. The amlodipine besylate USP is chemically described as 3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. The atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Its molecular formula is C66H68CaF2N4O10. The structural formulae for amlodipine besylate USP and atorvastatin calcium are shown below. Amlodipine besylate and atorvastatin calcium contains amlodipine besylate USP, a white or almost white powder, and atorvastatin calcium, a white to off-white colored powder, free from visible extraneous matter. Amlodipine besylate USP has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1155.36. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in water and in 2-proponal. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Amlodipine besylate and atorvastatin calcium is available as film-coated tablets containing: 1 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 2 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 3 2.5 mg amlodipine equivalent to 3.468 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.935 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 10 mg atorvastatin equivalent to 10.341 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 20 mg atorvastatin equivalent to 20.683 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 40 mg atorvastatin equivalent to 41.365 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.870 mg amlodipine besylate USP and 80 mg atorvastatin equivalent to 82.730 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>43744-322-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-322-60)</PackageDescription>
<NDC11Code>43744-0322-60</NDC11Code>
<ProductNDC>43744-322</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Doxapram Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120404</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>DOXAPRAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47335-322-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (47335-322-86) </PackageDescription>
<NDC11Code>47335-0322-86</NDC11Code>
<ProductNDC>47335-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090058</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride tablets, USP are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, talc, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol, talc, iron oxide red, yellow iron oxide, and FD&C yellow #6 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, polyethylene glycol, talc and black iron oxide (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>47993-322-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (47993-322-01) </PackageDescription>
<NDC11Code>47993-0322-01</NDC11Code>
<ProductNDC>47993-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50563-324-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50563-324-01) * 60 mL in 1 BOTTLE (50563-322-01) * 60 mL in 1 BOTTLE (50563-323-01) * 60 mL in 1 BOTTLE (50563-321-01) </PackageDescription>
<NDC11Code>50563-0324-01</NDC11Code>
<ProductNDC>50563-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beauty Concepts Antibacterial Hand Sanitizer Trio Winter Mint Unscented Frosted Berry</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201009</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51655-322-25</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-322-25) </PackageDescription>
<NDC11Code>51655-0322-25</NDC11Code>
<ProductNDC>51655-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209603</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha 1-adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl), USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride and it has the following structural formula:. Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white to off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, 300 mg or 400 mg of labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55292-322-60</NDCCode>
<PackageDescription>60 TABLET, COATED in 1 BLISTER PACK (55292-322-60) </PackageDescription>
<NDC11Code>55292-0322-60</NDC11Code>
<ProductNDC>55292-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isturisa</ProprietaryName>
<NonProprietaryName>Osilodrostat</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212801</ApplicationNumber>
<LabelerName>Recordati Rare Diseases, Inc.</LabelerName>
<SubstanceName>OSILODROSTAT PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cortisol Synthesis Inhibitor [EPC], Cytochrome P450 11B1 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-322-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55700-322-60)</PackageDescription>
<NDC11Code>55700-0322-60</NDC11Code>
<ProductNDC>55700-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078251</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>3.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>56062-322-16</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (56062-322-16) / 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>56062-0322-16</NDC11Code>
<ProductNDC>56062-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075598</ApplicationNumber>
<LabelerName>Publix Super Markets Inc</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60760-322-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (60760-322-60)</PackageDescription>
<NDC11Code>60760-0322-60</NDC11Code>
<ProductNDC>60760-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kadian Er</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101221</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020616</ApplicationNumber>
<LabelerName>St Marys Medical Park Pharmacy</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63187-322-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (63187-322-60) </PackageDescription>
<NDC11Code>63187-0322-60</NDC11Code>
<ProductNDC>63187-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073553</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo [a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>63874-322-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (63874-322-60)</PackageDescription>
<NDC11Code>63874-0322-60</NDC11Code>
<ProductNDC>63874-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>Altura Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</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 Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>64796-322-11</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOX (64796-322-11) </PackageDescription>
<NDC11Code>64796-0322-11</NDC11Code>
<ProductNDC>64796-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kindfill</ProprietaryName>
<NonProprietaryName>Cinnamon Toothpaste Tablets</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20230105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Identipak, Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66267-322-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (66267-322-60) </PackageDescription>
<NDC11Code>66267-0322-60</NDC11Code>
<ProductNDC>66267-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203126</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69343-322-60</NDCCode>
<PackageDescription>6 CANISTER in 1 CARTON (69343-322-60) > 1 CLOTH in 1 CANISTER</PackageDescription>
<NDC11Code>69343-0322-60</NDC11Code>
<ProductNDC>69343-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Elyptol Hand Sanitizer Wipe</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Elyptol Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>1/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72189-322-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (72189-322-60) </PackageDescription>
<NDC11Code>72189-0322-60</NDC11Code>
<ProductNDC>72189-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070322</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol hydrochloride tablets, USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol hydrochloride tablets, USP are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol hydrochloride tablets, USP are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol hydrochloride tablets, USP are not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol hydrochloride tablets, USP improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol hydrochloride tablets, USP are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. [chemical-structure]. C16H21NO2HCl M.W. 295.80. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Propranolol hydrochloride tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol hydrochloride tablets, USP also contain colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (40 mg and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg).</Description>
</NDC>
<NDC>
<NDCCode>75448-322-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (75448-322-01) </PackageDescription>
<NDC11Code>75448-0322-01</NDC11Code>
<ProductNDC>75448-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thrive Health Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200429</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Sanrace Biotechnology Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76282-322-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (76282-322-60) </PackageDescription>
<NDC11Code>76282-0322-60</NDC11Code>
<ProductNDC>76282-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76420-322-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (76420-322-60) </PackageDescription>
<NDC11Code>76420-0322-60</NDC11Code>
<ProductNDC>76420-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207419</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see Warnings], reserve Oxycodone and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):. : 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet, for oral administration contains: Oxycodone hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone Hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg* (*5 mg oxycodone Hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone Hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone Hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg. Inactive Ingredients The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Oxycodone and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4∙ HCl and the molecular weight is 381.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.17. It may be represented by the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>80487-322-11</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOX (80487-322-11) </PackageDescription>
<NDC11Code>80487-0322-11</NDC11Code>
<ProductNDC>80487-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kindfill</ProprietaryName>
<NonProprietaryName>Cinnamon Toothpaste Tablets</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20230105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>By Humankind Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83013-322-01</NDCCode>
<PackageDescription>60 g in 1 BOTTLE, PUMP (83013-322-01) </PackageDescription>
<NDC11Code>83013-0322-01</NDC11Code>
<ProductNDC>83013-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hismile</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>HISMILE PTY LTD</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.243</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83013-322-06</NDCCode>
<PackageDescription>60 g in 1 BOTTLE, PUMP (83013-322-06) </PackageDescription>
<NDC11Code>83013-0322-06</NDC11Code>
<ProductNDC>83013-322</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hismile</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>HISMILE PTY LTD</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.243</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>87063-322-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (87063-322-60) </PackageDescription>
<NDC11Code>87063-0322-60</NDC11Code>
<ProductNDC>87063-322</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202180</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone hydrochloride tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1).</IndicationAndUsage>
<Description>Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula:C 19H 22ClN 5O · HCl. Molecular Weight:408.33. Each tablet, for oral administration, contains 50 mg, 100 mg, or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, sodium lauryl sulfate, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42571-005-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42571-005-60) </PackageDescription>
<NDC11Code>42571-0005-60</NDC11Code>
<ProductNDC>42571-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090383</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
</NDCList>