{
"NDC": [
{
"NDCCode": "24979-200-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (24979-200-03) ",
"NDC11Code": "24979-0200-03",
"ProductNDC": "24979-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216782",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine hydrochloride tablets, USP, 20 mg for oral use contain 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride tanlets, USP, 20 mg also contain inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "24979-154-38",
"PackageDescription": "200 mL in 1 BOTTLE (24979-154-38) ",
"NDC11Code": "24979-0154-38",
"ProductNDC": "24979-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065336",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Cephalexin for oral suspension, USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria. Respiratory tract infection (1.1). Otitis media (1.2). Skin and skin structure infections (1.3). Bone infections (1.4). Genitourinary tract infections (1.5). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for oral suspension, USP and other antibacterial drugs, Cephalexin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. C16H17N3O4SH2O M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: strawberry powder, methylcellulose, sodium lauryl sulfate, sucrose and FD&C Red No. 40."
},
{
"NDCCode": "24979-155-38",
"PackageDescription": "200 mL in 1 BOTTLE (24979-155-38) ",
"NDC11Code": "24979-0155-38",
"ProductNDC": "24979-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065336",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Cephalexin for oral suspension, USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria. Respiratory tract infection (1.1). Otitis media (1.2). Skin and skin structure infections (1.3). Bone infections (1.4). Genitourinary tract infections (1.5). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for oral suspension, USP and other antibacterial drugs, Cephalexin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. C16H17N3O4SH2O M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: strawberry powder, methylcellulose, sodium lauryl sulfate, sucrose and FD&C Red No. 40."
},
{
"NDCCode": "24979-200-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (24979-200-01) ",
"NDC11Code": "24979-0200-01",
"ProductNDC": "24979-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216782",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine hydrochloride tablets, USP, 20 mg for oral use contain 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride tanlets, USP, 20 mg also contain inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "24979-200-02",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (24979-200-02) ",
"NDC11Code": "24979-0200-02",
"ProductNDC": "24979-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216782",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine hydrochloride tablets, USP, 20 mg for oral use contain 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride tanlets, USP, 20 mg also contain inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "24979-037-03",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-037-03) ",
"NDC11Code": "24979-0037-03",
"ProductNDC": "24979-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-038-03",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-038-03) ",
"NDC11Code": "24979-0038-03",
"ProductNDC": "24979-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-039-03",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-039-03) ",
"NDC11Code": "24979-0039-03",
"ProductNDC": "24979-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-132-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE (24979-132-03) ",
"NDC11Code": "24979-0132-03",
"ProductNDC": "24979-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terbutaline Sulfate",
"NonProprietaryName": "Terbutaline Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211832",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "TERBUTALINE SULFATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200713",
"SamplePackage": "N",
"IndicationAndUsage": "Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.",
"Description": "Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-α-[(tert –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular formula is (C12H19NO3)2 H2SO4 and the structural formula is. Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, povidone, and magnesium stearate."
},
{
"NDCCode": "24979-133-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE (24979-133-03) ",
"NDC11Code": "24979-0133-03",
"ProductNDC": "24979-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terbutaline Sulfate",
"NonProprietaryName": "Terbutaline Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211832",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "TERBUTALINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200713",
"SamplePackage": "N",
"IndicationAndUsage": "Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.",
"Description": "Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-α-[(tert –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular formula is (C12H19NO3)2 H2SO4 and the structural formula is. Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, povidone, and magnesium stearate."
},
{
"NDCCode": "24979-153-03",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-153-03) ",
"NDC11Code": "24979-0153-03",
"ProductNDC": "24979-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213247",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: crospovidone, povidone (K-30, K-90), pregelatinised starch, magnesium stearate, sodium lauryl sulfate, hydroxypropyl cellulose, talc, cellulose acetate, polyethylene glycol (PEG 400, PEG 3350), triacetin, polyvinyl alcohol, titanium dioxide, black iron oxide, propylene glycol and hypromellose. FDA approved dissolution test specifications differ from the USP."
},
{
"NDCCode": "24979-201-03",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (24979-201-03) ",
"NDC11Code": "24979-0201-03",
"ProductNDC": "24979-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217054",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230201",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride capsules, USP, are antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP, 10 mg for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate, and iron oxide black."
},
{
"NDCCode": "24979-229-03",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-229-03) ",
"NDC11Code": "24979-0229-03",
"ProductNDC": "24979-229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218979",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium Chloride Extended-release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Paraffin wax pastilles, ethylcellulose, triethyl citrate, colloidal silicon dioxide, and magnesium stearate. White tablets also contain polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, and talc. Yellow tablets also contain polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, D&C Yellow No. 10 aluminum lake, and FD&C Yellow No. 6 aluminum lake. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test."
},
{
"NDCCode": "24979-230-03",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-230-03) ",
"NDC11Code": "24979-0230-03",
"ProductNDC": "24979-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218979",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium Chloride Extended-release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Paraffin wax pastilles, ethylcellulose, triethyl citrate, colloidal silicon dioxide, and magnesium stearate. White tablets also contain polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, and talc. Yellow tablets also contain polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, D&C Yellow No. 10 aluminum lake, and FD&C Yellow No. 6 aluminum lake. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test."
},
{
"NDCCode": "24979-231-03",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-231-03) ",
"NDC11Code": "24979-0231-03",
"ProductNDC": "24979-231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209688",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230410",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets are solid oral dosage form of potassium chloride containing 750 mg and 1,500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq tablets also contain colloidal silicon dioxide, D&C Yellow No. 10 aluminum Lake, ethylcellulose, FD&C Yellow No. 6, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 20 mEq tablets also contain colloidal silicon dioxide, ethylcellulose, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. USP Dissolution Test pending."
},
{
"NDCCode": "24979-037-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-037-01) ",
"NDC11Code": "24979-0037-01",
"ProductNDC": "24979-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-037-02",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-037-02) ",
"NDC11Code": "24979-0037-02",
"ProductNDC": "24979-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-038-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-038-01) ",
"NDC11Code": "24979-0038-01",
"ProductNDC": "24979-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-038-02",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-038-02) ",
"NDC11Code": "24979-0038-02",
"ProductNDC": "24979-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-039-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-039-01) ",
"NDC11Code": "24979-0039-01",
"ProductNDC": "24979-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-039-02",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-039-02) ",
"NDC11Code": "24979-0039-02",
"ProductNDC": "24979-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-040-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-040-01) ",
"NDC11Code": "24979-0040-01",
"ProductNDC": "24979-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-040-09",
"PackageDescription": "800 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-040-09) ",
"NDC11Code": "24979-0040-09",
"ProductNDC": "24979-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": ". : 1 , 2 , 3 .",
"Description": "Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide."
},
{
"NDCCode": "24979-169-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (24979-169-01) ",
"NDC11Code": "24979-0169-01",
"ProductNDC": "24979-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209603",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N"
},
{
"NDCCode": "24979-169-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (24979-169-02) ",
"NDC11Code": "24979-0169-02",
"ProductNDC": "24979-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209603",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N"
},
{
"NDCCode": "24979-169-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (24979-169-06) ",
"NDC11Code": "24979-0169-06",
"ProductNDC": "24979-169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209603",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N"
},
{
"NDCCode": "24979-715-04",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (24979-715-04) ",
"NDC11Code": "24979-0715-04",
"ProductNDC": "24979-715",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorafenib",
"NonProprietaryName": "Sorafenib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209050",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "SORAFENIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"Description": "Sorafenib, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2-methylpyridine-2-carboxamide 4 methylbenzenesulfonate. The molecular formula of sorafenib tosylate is C21H16ClF3N4O3 x C7H8O3S and the molecular weight of sorafenib tosylate is 637.0 g/mole. Its structural. formula is. :. Sorafenib tosylate is a white to yellowish or brownish solid. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400. Sorafenib Tablets, USP for oral use is supplied as film-coated tablets containing 200 mg sorafenib equivalent to 274 mg sorafenib tosylate and the following inactive ingredients: croscarmellose sodium, ferric oxide red, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "24979-715-44",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (24979-715-44) ",
"NDC11Code": "24979-0715-44",
"ProductNDC": "24979-715",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorafenib",
"NonProprietaryName": "Sorafenib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209050",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "SORAFENIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"Description": "Sorafenib, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2-methylpyridine-2-carboxamide 4 methylbenzenesulfonate. The molecular formula of sorafenib tosylate is C21H16ClF3N4O3 x C7H8O3S and the molecular weight of sorafenib tosylate is 637.0 g/mole. Its structural. formula is. :. Sorafenib tosylate is a white to yellowish or brownish solid. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400. Sorafenib Tablets, USP for oral use is supplied as film-coated tablets containing 200 mg sorafenib equivalent to 274 mg sorafenib tosylate and the following inactive ingredients: croscarmellose sodium, ferric oxide red, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "24979-141-36",
"PackageDescription": "1 TUBE in 1 CARTON (24979-141-36) > 28.35 g in 1 TUBE",
"NDC11Code": "24979-0141-36",
"ProductNDC": "24979-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroquinone",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170616",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TWi Pharmaceuticals, Inc.",
"SubstanceName": "HYDROQUINONE",
"StrengthNumber": "40",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170616",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.",
"Description": "Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg hydroquinone USP, in a vanishing cream base of glyceryl monostearate, mineral oil, PEG-25 propylene glycol stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, sodium metabisulfite, squalane and stearic acid. Chemically, hydroquinone is C6H6O2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is."
},
{
"NDCCode": "24979-201-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (24979-201-01) ",
"NDC11Code": "24979-0201-01",
"ProductNDC": "24979-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217054",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230201",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride capsules, USP, are antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP, 10 mg for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate, and iron oxide black."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>24979-200-03</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (24979-200-03) </PackageDescription>
<NDC11Code>24979-0200-03</NDC11Code>
<ProductNDC>24979-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216782</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine hydrochloride tablets, USP, 20 mg for oral use contain 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride tanlets, USP, 20 mg also contain inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid.</Description>
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<NDC>
<NDCCode>24979-154-38</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (24979-154-38) </PackageDescription>
<NDC11Code>24979-0154-38</NDC11Code>
<ProductNDC>24979-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065336</ApplicationNumber>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cephalexin for oral suspension, USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria. Respiratory tract infection (1.1). Otitis media (1.2). Skin and skin structure infections (1.3). Bone infections (1.4). Genitourinary tract infections (1.5). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for oral suspension, USP and other antibacterial drugs, Cephalexin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. C16H17N3O4SH2O M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: strawberry powder, methylcellulose, sodium lauryl sulfate, sucrose and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>24979-155-38</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (24979-155-38) </PackageDescription>
<NDC11Code>24979-0155-38</NDC11Code>
<ProductNDC>24979-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065336</ApplicationNumber>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cephalexin for oral suspension, USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria. Respiratory tract infection (1.1). Otitis media (1.2). Skin and skin structure infections (1.3). Bone infections (1.4). Genitourinary tract infections (1.5). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin for oral suspension, USP and other antibacterial drugs, Cephalexin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6).</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. C16H17N3O4SH2O M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: strawberry powder, methylcellulose, sodium lauryl sulfate, sucrose and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>24979-200-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (24979-200-01) </PackageDescription>
<NDC11Code>24979-0200-01</NDC11Code>
<ProductNDC>24979-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216782</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine hydrochloride tablets, USP, 20 mg for oral use contain 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride tanlets, USP, 20 mg also contain inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>24979-200-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (24979-200-02) </PackageDescription>
<NDC11Code>24979-0200-02</NDC11Code>
<ProductNDC>24979-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216782</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride, USP is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine hydrochloride tablets, USP, 20 mg for oral use contain 20 mg dicyclomine hydrochloride, USP. Dicyclomine hydrochloride tanlets, USP, 20 mg also contain inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>24979-037-03</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-037-03) </PackageDescription>
<NDC11Code>24979-0037-03</NDC11Code>
<ProductNDC>24979-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24979-038-03</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-038-03) </PackageDescription>
<NDC11Code>24979-0038-03</NDC11Code>
<ProductNDC>24979-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24979-039-03</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-039-03) </PackageDescription>
<NDC11Code>24979-0039-03</NDC11Code>
<ProductNDC>24979-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24979-132-03</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (24979-132-03) </PackageDescription>
<NDC11Code>24979-0132-03</NDC11Code>
<ProductNDC>24979-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terbutaline Sulfate</ProprietaryName>
<NonProprietaryName>Terbutaline Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211832</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>TERBUTALINE SULFATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.</IndicationAndUsage>
<Description>Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-α-[(tert –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular formula is (C12H19NO3)2 H2SO4 and the structural formula is. Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>24979-133-03</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (24979-133-03) </PackageDescription>
<NDC11Code>24979-0133-03</NDC11Code>
<ProductNDC>24979-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terbutaline Sulfate</ProprietaryName>
<NonProprietaryName>Terbutaline Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211832</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>TERBUTALINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.</IndicationAndUsage>
<Description>Terbutaline sulfate USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-α-[(tert –butylamino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). The molecular formula is (C12H19NO3)2 H2SO4 and the structural formula is. Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. Its molecular weight is 548.65. Inactive Ingredients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>24979-153-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-153-03) </PackageDescription>
<NDC11Code>24979-0153-03</NDC11Code>
<ProductNDC>24979-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213247</ApplicationNumber>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: crospovidone, povidone (K-30, K-90), pregelatinised starch, magnesium stearate, sodium lauryl sulfate, hydroxypropyl cellulose, talc, cellulose acetate, polyethylene glycol (PEG 400, PEG 3350), triacetin, polyvinyl alcohol, titanium dioxide, black iron oxide, propylene glycol and hypromellose. FDA approved dissolution test specifications differ from the USP.</Description>
</NDC>
<NDC>
<NDCCode>24979-201-03</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (24979-201-03) </PackageDescription>
<NDC11Code>24979-0201-03</NDC11Code>
<ProductNDC>24979-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217054</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride capsules, USP, are antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP, 10 mg for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate, and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>24979-229-03</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-229-03) </PackageDescription>
<NDC11Code>24979-0229-03</NDC11Code>
<ProductNDC>24979-229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218979</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium Chloride Extended-release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Paraffin wax pastilles, ethylcellulose, triethyl citrate, colloidal silicon dioxide, and magnesium stearate. White tablets also contain polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, and talc. Yellow tablets also contain polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, D&C Yellow No. 10 aluminum lake, and FD&C Yellow No. 6 aluminum lake. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test.</Description>
</NDC>
<NDC>
<NDCCode>24979-230-03</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-230-03) </PackageDescription>
<NDC11Code>24979-0230-03</NDC11Code>
<ProductNDC>24979-230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218979</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium Chloride Extended-release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Paraffin wax pastilles, ethylcellulose, triethyl citrate, colloidal silicon dioxide, and magnesium stearate. White tablets also contain polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, and talc. Yellow tablets also contain polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, D&C Yellow No. 10 aluminum lake, and FD&C Yellow No. 6 aluminum lake. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test.</Description>
</NDC>
<NDC>
<NDCCode>24979-231-03</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-231-03) </PackageDescription>
<NDC11Code>24979-0231-03</NDC11Code>
<ProductNDC>24979-231</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209688</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets are solid oral dosage form of potassium chloride containing 750 mg and 1,500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq tablets also contain colloidal silicon dioxide, D&C Yellow No. 10 aluminum Lake, ethylcellulose, FD&C Yellow No. 6, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 20 mEq tablets also contain colloidal silicon dioxide, ethylcellulose, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>24979-037-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-037-01) </PackageDescription>
<NDC11Code>24979-0037-01</NDC11Code>
<ProductNDC>24979-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24979-037-02</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-037-02) </PackageDescription>
<NDC11Code>24979-0037-02</NDC11Code>
<ProductNDC>24979-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24979-038-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-038-01) </PackageDescription>
<NDC11Code>24979-0038-01</NDC11Code>
<ProductNDC>24979-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
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<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
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<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
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<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
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<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
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<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
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<IndicationAndUsage>. : 1 , 2 , 3 .</IndicationAndUsage>
<Description>Metoprolol succinate extended-release tablets are beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: ethyl cellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.</Description>
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<LastUpdate>2021-12-28</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<LastUpdate>2021-12-28</LastUpdate>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2026-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<Description>Sorafenib, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2-methylpyridine-2-carboxamide 4 methylbenzenesulfonate. The molecular formula of sorafenib tosylate is C21H16ClF3N4O3 x C7H8O3S and the molecular weight of sorafenib tosylate is 637.0 g/mole. Its structural. formula is. :. Sorafenib tosylate is a white to yellowish or brownish solid. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400. Sorafenib Tablets, USP for oral use is supplied as film-coated tablets containing 200 mg sorafenib equivalent to 274 mg sorafenib tosylate and the following inactive ingredients: croscarmellose sodium, ferric oxide red, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sorafenib, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2-methylpyridine-2-carboxamide 4 methylbenzenesulfonate. The molecular formula of sorafenib tosylate is C21H16ClF3N4O3 x C7H8O3S and the molecular weight of sorafenib tosylate is 637.0 g/mole. Its structural. formula is. :. Sorafenib tosylate is a white to yellowish or brownish solid. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400. Sorafenib Tablets, USP for oral use is supplied as film-coated tablets containing 200 mg sorafenib equivalent to 274 mg sorafenib tosylate and the following inactive ingredients: croscarmellose sodium, ferric oxide red, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TWi Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROQUINONE</SubstanceName>
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<StrengthUnit>mg/g</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.</IndicationAndUsage>
<Description>Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg hydroquinone USP, in a vanishing cream base of glyceryl monostearate, mineral oil, PEG-25 propylene glycol stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, sodium metabisulfite, squalane and stearic acid. Chemically, hydroquinone is C6H6O2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is.</Description>
</NDC>
<NDC>
<NDCCode>24979-201-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (24979-201-01) </PackageDescription>
<NDC11Code>24979-0201-01</NDC11Code>
<ProductNDC>24979-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217054</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride capsules, USP, are antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: 1 Dicyclomine Hydrochloride Capsules, USP, 10 mg for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate, and iron oxide black.</Description>
</NDC>
</NDCList>