{
"NDC": [
{
"NDCCode": "0781-5222-29",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (0781-5222-29)",
"NDC11Code": "00781-5222-29",
"ProductNDC": "0781-5222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0781-5222-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5222-01) ",
"NDC11Code": "00781-5222-01",
"ProductNDC": "0781-5222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070905",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, polyvinyl pyrrolidone and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The Dissolution test to be performed according to USP Test 2."
},
{
"NDCCode": "0781-5222-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0781-5222-60)",
"NDC11Code": "00781-5222-60",
"ProductNDC": "0781-5222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0781-5221-29",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (0781-5221-29)",
"NDC11Code": "00781-5221-29",
"ProductNDC": "0781-5221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "3.125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0781-5223-29",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (0781-5223-29)",
"NDC11Code": "00781-5223-29",
"ProductNDC": "0781-5223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0781-5224-29",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (0781-5224-29)",
"NDC11Code": "00781-5224-29",
"ProductNDC": "0781-5224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0781-7146-29",
"PackageDescription": "12 POUCH in 1 CARTON (0781-7146-29) > 5 AMPULE in 1 POUCH (0781-7146-51) > 3 mL in 1 AMPULE",
"NDC11Code": "00781-7146-29",
"ProductNDC": "0781-7146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202496",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 3",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0781-7155-29",
"PackageDescription": "2 POUCH in 1 CARTON (0781-7155-29) > 30 AMPULE in 1 POUCH > 3 mL in 1 AMPULE",
"NDC11Code": "00781-7155-29",
"ProductNDC": "0781-7155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077839",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0781-7157-29",
"PackageDescription": "2 POUCH in 1 CARTON (0781-7157-29) > 30 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE",
"NDC11Code": "00781-7157-29",
"ProductNDC": "0781-7157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.",
"Description": "The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (+)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C20H30BrNO3H2O Mol.Wt. 430.4. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid."
},
{
"NDCCode": "0781-1943-39",
"PackageDescription": "40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39) ",
"NDC11Code": "00781-1943-39",
"ProductNDC": "0781-1943",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM",
"StrengthNumber": "562.5; 437.5; 62.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100421",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: 1 community-acquired pneumonia or, 2 acute bacterial sinusitis.",
"Description": "Amoxicillin and clavulanate potassium extended-release tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3‑ dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino(4‑ hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2‑ carboxylic acid monosodium salt and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β‑lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as. Each tablet of amoxicillin and clavulanate potassium extended-release contains 1,000 mg of amoxicillin (437.5 mg as amoxicillin sodium and 562.5 mg as amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of amoxicillin and clavulanate potassium extended-release tablets contains approximately 12 mg of potassium and 29 mg of sodium. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0781-1943-82",
"PackageDescription": "28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82) ",
"NDC11Code": "00781-1943-82",
"ProductNDC": "0781-1943",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM",
"StrengthNumber": "562.5; 437.5; 62.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100421",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: 1 community-acquired pneumonia or, 2 acute bacterial sinusitis.",
"Description": "Amoxicillin and clavulanate potassium extended-release tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3‑ dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino(4‑ hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2‑ carboxylic acid monosodium salt and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β‑lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as. Each tablet of amoxicillin and clavulanate potassium extended-release contains 1,000 mg of amoxicillin (437.5 mg as amoxicillin sodium and 562.5 mg as amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of amoxicillin and clavulanate potassium extended-release tablets contains approximately 12 mg of potassium and 29 mg of sodium. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0781-2201-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0781-2201-05) ",
"NDC11Code": "00781-2201-05",
"ProductNDC": "0781-2201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880112",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071427",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-02-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19880112",
"EndMarketingDatePackage": "20200228",
"SamplePackage": "N"
},
{
"NDCCode": "0781-2791-64",
"PackageDescription": "240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2791-64) ",
"NDC11Code": "00781-2791-64",
"ProductNDC": "0781-2791",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219997",
"LabelerName": "Sandoz Inc",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260721",
"SamplePackage": "N",
"IndicationAndUsage": "Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.",
"Description": "Mesalamine for oral administration is an extended-release formulation of mesalamine, USP an aminosalicylate anti-inflammatory agent for gastrointestinal use. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. It has a molecular weight of 153.14 g/mol and the molecular formula is C7H7NO3. The structural formula is. Each 250 mg mesalamine extended-release capsule, USP contains 250 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, diacetylated monoglycerides, ethyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, povidone K90, stearic acid, sugar (spheres), and talc. The capsule shell contains FD&C Blue #1, gelatin, iron oxide yellow, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Each 500 mg mesalamine extended-release capsule, USP contains 500 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, diacetylated monoglycerides, ethyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, povidone K90, stearic acid, sugar (spheres), and talc. The capsule shell contains FD&C Blue #1, gelatin, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0781-2793-72",
"PackageDescription": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2793-72) ",
"NDC11Code": "00781-2793-72",
"ProductNDC": "0781-2793",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesalamine",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219997",
"LabelerName": "Sandoz Inc",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.",
"Description": "Mesalamine for oral administration is an extended-release formulation of mesalamine, USP an aminosalicylate anti-inflammatory agent for gastrointestinal use. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. It has a molecular weight of 153.14 g/mol and the molecular formula is C7H7NO3. The structural formula is. Each 250 mg mesalamine extended-release capsule, USP contains 250 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, diacetylated monoglycerides, ethyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, povidone K90, stearic acid, sugar (spheres), and talc. The capsule shell contains FD&C Blue #1, gelatin, iron oxide yellow, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Each 500 mg mesalamine extended-release capsule, USP contains 500 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, diacetylated monoglycerides, ethyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, povidone K90, stearic acid, sugar (spheres), and talc. The capsule shell contains FD&C Blue #1, gelatin, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0781-3468-95",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3468-95) / 2 mL in 1 VIAL, SINGLE-DOSE (0781-3468-72) ",
"NDC11Code": "00781-3468-95",
"ProductNDC": "0781-3468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214311",
"LabelerName": "Sandoz Inc",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
},
{
"NDCCode": "0781-3469-95",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3469-95) / 5 mL in 1 VIAL, SINGLE-DOSE (0781-3469-72) ",
"NDC11Code": "00781-3469-95",
"ProductNDC": "0781-3469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214311",
"LabelerName": "Sandoz Inc",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
},
{
"NDCCode": "0781-5578-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01) ",
"NDC11Code": "00781-5578-01",
"ProductNDC": "0781-5578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Entacapone",
"NonProprietaryName": "Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140604",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020796",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ENTACAPONE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140604",
"SamplePackage": "N",
"IndicationAndUsage": "Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone tablet’s effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.",
"Description": "Entacapone is available as tablets containing 200 mg entacapone. Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson’s disease as an adjunct to levodopa and carbidopa therapy. It is a nitrocatechol-structured compound with a relative molecular mass of 305.29. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. The inactive ingredients of the entacapone tablets are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hydroxypropyl methylcellulose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide, red iron oxide and titanium dioxide."
},
{
"NDCCode": "0781-5776-31",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0781-5776-31) ",
"NDC11Code": "00781-5776-31",
"ProductNDC": "0781-5776",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065211",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170302",
"SamplePackage": "N"
},
{
"NDCCode": "0781-5776-69",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0781-5776-69) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00781-5776-69",
"ProductNDC": "0781-5776",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065211",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170302",
"SamplePackage": "N"
},
{
"NDCCode": "0781-6087-16",
"PackageDescription": "473 mL in 1 BOTTLE (0781-6087-16)",
"NDC11Code": "00781-6087-16",
"ProductNDC": "0781-6087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "SYRUP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111025",
"EndMarketingDate": "20201025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090054",
"LabelerName": "Sandoz Inc.",
"SubstanceName": "RANITIDINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-10-29",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0781-8052-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0781-8052-01) ",
"NDC11Code": "00781-8052-01",
"ProductNDC": "0781-8052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074477",
"LabelerName": "SANDOZ INC.",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160701",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
"Description": "Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "0781-8052-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0781-8052-10) ",
"NDC11Code": "00781-8052-10",
"ProductNDC": "0781-8052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074477",
"LabelerName": "SANDOZ INC.",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160701",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
"Description": "Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "0781-8061-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0781-8061-01) ",
"NDC11Code": "00781-8061-01",
"ProductNDC": "0781-8061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074477",
"LabelerName": "SANDOZ INC.",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160701",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
"Description": "Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "0781-8061-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0781-8061-10) ",
"NDC11Code": "00781-8061-10",
"ProductNDC": "0781-8061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074477",
"LabelerName": "SANDOZ INC.",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160701",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
"Description": "Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "0781-8075-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0781-8075-01) ",
"NDC11Code": "00781-8075-01",
"ProductNDC": "0781-8075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074477",
"LabelerName": "SANDOZ INC.",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160701",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
"Description": "Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "0781-8075-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0781-8075-10) ",
"NDC11Code": "00781-8075-10",
"ProductNDC": "0781-8075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074477",
"LabelerName": "SANDOZ INC.",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160701",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
"Description": "Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "0781-8080-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0781-8080-01) ",
"NDC11Code": "00781-8080-01",
"ProductNDC": "0781-8080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074477",
"LabelerName": "SANDOZ INC.",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160701",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.",
"Description": "Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "31722-781-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (31722-781-30) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "31722-0781-30",
"ProductNDC": "31722-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Afatinib",
"NonProprietaryName": "Afatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210750",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AFATINIB DIMALEATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260714",
"SamplePackage": "N",
"IndicationAndUsage": "Afatinib tablets are a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1) Limitations of Use: Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations ( 1.1) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2).",
"Description": "Afatinib tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-,(2Z)-2-butenedioate(1:2). Its structural formula is. Afatinib dimaleate is an off-white to yellow color, hygroscopic powder, slightly soluble in dimethyl sulfoxide, dimethylformamide and very slightly soluble in water, with an empirical formula of C 24H 25ClFN 5O 3.2C 4H 4O 4(1:2), and a relative molecular mass of 718.09. Afatinib tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg afatinib dimaleate, respectively). The inactive ingredients of afatinib tablets are the following: Tablet Core: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Coating: hypromellose, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "37205-781-37",
"PackageDescription": "177 mL in 1 BOTTLE (37205-781-37)",
"NDC11Code": "37205-0781-37",
"ProductNDC": "37205-781",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Nite Time",
"ProprietaryNameSuffix": "Multi Symptom Cold Flu Relief",
"NonProprietaryName": "Acetaminophen,dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20060629",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Cardinal Health",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "37205-781-42",
"PackageDescription": "296 mL in 1 BOTTLE (37205-781-42)",
"NDC11Code": "37205-0781-42",
"ProductNDC": "37205-781",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Nite Time",
"ProprietaryNameSuffix": "Multi Symptom Cold Flu Relief",
"NonProprietaryName": "Acetaminophen,dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20060629",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Cardinal Health",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 15; 6.25",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0781-5222-29</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (0781-5222-29)</PackageDescription>
<NDC11Code>00781-5222-29</NDC11Code>
<ProductNDC>0781-5222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0781-5222-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0781-5222-01) </PackageDescription>
<NDC11Code>00781-5222-01</NDC11Code>
<ProductNDC>0781-5222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets, USP are white, oval, film-coated containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, polyvinyl pyrrolidone and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The Dissolution test to be performed according to USP Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0781-5222-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0781-5222-60)</PackageDescription>
<NDC11Code>00781-5222-60</NDC11Code>
<ProductNDC>0781-5222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0781-5221-29</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (0781-5221-29)</PackageDescription>
<NDC11Code>00781-5221-29</NDC11Code>
<ProductNDC>0781-5221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>3.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0781-5223-29</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (0781-5223-29)</PackageDescription>
<NDC11Code>00781-5223-29</NDC11Code>
<ProductNDC>0781-5223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0781-5224-29</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (0781-5224-29)</PackageDescription>
<NDC11Code>00781-5224-29</NDC11Code>
<ProductNDC>0781-5224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0781-7146-29</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (0781-7146-29) > 5 AMPULE in 1 POUCH (0781-7146-51) > 3 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00781-7146-29</NDC11Code>
<ProductNDC>0781-7146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202496</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.5; 3</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0781-7155-29</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (0781-7155-29) > 30 AMPULE in 1 POUCH > 3 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00781-7155-29</NDC11Code>
<ProductNDC>0781-7155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077839</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0781-7157-29</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (0781-7157-29) > 30 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00781-7157-29</NDC11Code>
<ProductNDC>0781-7157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.</IndicationAndUsage>
<Description>The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (+)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C20H30BrNO3H2O Mol.Wt. 430.4. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>0781-1943-39</NDCCode>
<PackageDescription>40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39) </PackageDescription>
<NDC11Code>00781-1943-39</NDC11Code>
<ProductNDC>0781-1943</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>562.5; 437.5; 62.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: 1 community-acquired pneumonia or, 2 acute bacterial sinusitis.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium extended-release tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3‑ dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino(4‑ hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2‑ carboxylic acid monosodium salt and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β‑lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as. Each tablet of amoxicillin and clavulanate potassium extended-release contains 1,000 mg of amoxicillin (437.5 mg as amoxicillin sodium and 562.5 mg as amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of amoxicillin and clavulanate potassium extended-release tablets contains approximately 12 mg of potassium and 29 mg of sodium. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0781-1943-82</NDCCode>
<PackageDescription>28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82) </PackageDescription>
<NDC11Code>00781-1943-82</NDC11Code>
<ProductNDC>0781-1943</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>562.5; 437.5; 62.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: 1 community-acquired pneumonia or, 2 acute bacterial sinusitis.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium extended-release tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3‑ dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino(4‑ hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2‑ carboxylic acid monosodium salt and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β‑lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as. Each tablet of amoxicillin and clavulanate potassium extended-release contains 1,000 mg of amoxicillin (437.5 mg as amoxicillin sodium and 562.5 mg as amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of amoxicillin and clavulanate potassium extended-release tablets contains approximately 12 mg of potassium and 29 mg of sodium. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0781-2201-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0781-2201-05) </PackageDescription>
<NDC11Code>00781-2201-05</NDC11Code>
<ProductNDC>0781-2201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880112</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071427</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-02-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880112</StartMarketingDatePackage>
<EndMarketingDatePackage>20200228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-2791-64</NDCCode>
<PackageDescription>240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2791-64) </PackageDescription>
<NDC11Code>00781-2791-64</NDC11Code>
<ProductNDC>0781-2791</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesalamine</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219997</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.</IndicationAndUsage>
<Description>Mesalamine for oral administration is an extended-release formulation of mesalamine, USP an aminosalicylate anti-inflammatory agent for gastrointestinal use. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. It has a molecular weight of 153.14 g/mol and the molecular formula is C7H7NO3. The structural formula is. Each 250 mg mesalamine extended-release capsule, USP contains 250 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, diacetylated monoglycerides, ethyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, povidone K90, stearic acid, sugar (spheres), and talc. The capsule shell contains FD&C Blue #1, gelatin, iron oxide yellow, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Each 500 mg mesalamine extended-release capsule, USP contains 500 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, diacetylated monoglycerides, ethyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, povidone K90, stearic acid, sugar (spheres), and talc. The capsule shell contains FD&C Blue #1, gelatin, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0781-2793-72</NDCCode>
<PackageDescription>120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2793-72) </PackageDescription>
<NDC11Code>00781-2793-72</NDC11Code>
<ProductNDC>0781-2793</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesalamine</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219997</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.</IndicationAndUsage>
<Description>Mesalamine for oral administration is an extended-release formulation of mesalamine, USP an aminosalicylate anti-inflammatory agent for gastrointestinal use. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. It has a molecular weight of 153.14 g/mol and the molecular formula is C7H7NO3. The structural formula is. Each 250 mg mesalamine extended-release capsule, USP contains 250 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, diacetylated monoglycerides, ethyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, povidone K90, stearic acid, sugar (spheres), and talc. The capsule shell contains FD&C Blue #1, gelatin, iron oxide yellow, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Each 500 mg mesalamine extended-release capsule, USP contains 500 mg of mesalamine, USP. It also contains the following inactive ingredients: castor oil, diacetylated monoglycerides, ethyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, povidone K90, stearic acid, sugar (spheres), and talc. The capsule shell contains FD&C Blue #1, gelatin, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0781-3468-95</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3468-95) / 2 mL in 1 VIAL, SINGLE-DOSE (0781-3468-72) </PackageDescription>
<NDC11Code>00781-3468-95</NDC11Code>
<ProductNDC>0781-3468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214311</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0781-3469-95</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3469-95) / 5 mL in 1 VIAL, SINGLE-DOSE (0781-3469-72) </PackageDescription>
<NDC11Code>00781-3469-95</NDC11Code>
<ProductNDC>0781-3469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214311</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0781-5578-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01) </PackageDescription>
<NDC11Code>00781-5578-01</NDC11Code>
<ProductNDC>0781-5578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Entacapone</ProprietaryName>
<NonProprietaryName>Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140604</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020796</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ENTACAPONE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone tablet’s effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.</IndicationAndUsage>
<Description>Entacapone is available as tablets containing 200 mg entacapone. Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson’s disease as an adjunct to levodopa and carbidopa therapy. It is a nitrocatechol-structured compound with a relative molecular mass of 305.29. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. The inactive ingredients of the entacapone tablets are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hydroxypropyl methylcellulose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide, red iron oxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0781-5776-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0781-5776-31) </PackageDescription>
<NDC11Code>00781-5776-31</NDC11Code>
<ProductNDC>0781-5776</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065211</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-5776-69</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0781-5776-69) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00781-5776-69</NDC11Code>
<ProductNDC>0781-5776</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065211</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-6087-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0781-6087-16)</PackageDescription>
<NDC11Code>00781-6087-16</NDC11Code>
<ProductNDC>0781-6087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111025</StartMarketingDate>
<EndMarketingDate>20201025</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090054</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<SubstanceName>RANITIDINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-29</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0781-8052-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0781-8052-01) </PackageDescription>
<NDC11Code>00781-8052-01</NDC11Code>
<ProductNDC>0781-8052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril</ProprietaryName>
<NonProprietaryName>Captopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074477</ApplicationNumber>
<LabelerName>SANDOZ INC.</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
<Description>Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0781-8052-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0781-8052-10) </PackageDescription>
<NDC11Code>00781-8052-10</NDC11Code>
<ProductNDC>0781-8052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril</ProprietaryName>
<NonProprietaryName>Captopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074477</ApplicationNumber>
<LabelerName>SANDOZ INC.</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
<Description>Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid.</Description>
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<NDCCode>0781-8061-01</NDCCode>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074477</ApplicationNumber>
<LabelerName>SANDOZ INC.</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
<Description>Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0781-8061-10</NDCCode>
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<ProductNDC>0781-8061</ProductNDC>
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<ApplicationNumber>ANDA074477</ApplicationNumber>
<LabelerName>SANDOZ INC.</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
<Description>Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0781-8075-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0781-8075-01) </PackageDescription>
<NDC11Code>00781-8075-01</NDC11Code>
<ProductNDC>0781-8075</ProductNDC>
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<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074477</ApplicationNumber>
<LabelerName>SANDOZ INC.</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
<Description>Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid.</Description>
</NDC>
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<NDCCode>0781-8075-10</NDCCode>
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<ProductNDC>0781-8075</ProductNDC>
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<DosageFormName>TABLET</DosageFormName>
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<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074477</ApplicationNumber>
<LabelerName>SANDOZ INC.</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
<Description>Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0781-8080-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0781-8080-01) </PackageDescription>
<NDC11Code>00781-8080-01</NDC11Code>
<ProductNDC>0781-8080</ProductNDC>
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<ProprietaryName>Captopril</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074477</ApplicationNumber>
<LabelerName>SANDOZ INC.</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.</IndicationAndUsage>
<Description>Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure. C9H15NO3S. Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>31722-781-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (31722-781-30) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0781-30</NDC11Code>
<ProductNDC>31722-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Afatinib</ProprietaryName>
<NonProprietaryName>Afatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210750</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AFATINIB DIMALEATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Afatinib tablets are a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1) Limitations of Use: Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations ( 1.1) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2).</IndicationAndUsage>
<Description>Afatinib tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-,(2Z)-2-butenedioate(1:2). Its structural formula is. Afatinib dimaleate is an off-white to yellow color, hygroscopic powder, slightly soluble in dimethyl sulfoxide, dimethylformamide and very slightly soluble in water, with an empirical formula of C 24H 25ClFN 5O 3.2C 4H 4O 4(1:2), and a relative molecular mass of 718.09. Afatinib tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg afatinib dimaleate, respectively). The inactive ingredients of afatinib tablets are the following: Tablet Core: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Coating: hypromellose, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
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<NDC>
<NDCCode>37205-781-37</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE (37205-781-37)</PackageDescription>
<NDC11Code>37205-0781-37</NDC11Code>
<ProductNDC>37205-781</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Nite Time</ProprietaryName>
<ProprietaryNameSuffix>Multi Symptom Cold Flu Relief</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen,dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060629</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>37205-781-42</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE (37205-781-42)</PackageDescription>
<NDC11Code>37205-0781-42</NDC11Code>
<ProductNDC>37205-781</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Nite Time</ProprietaryName>
<ProprietaryNameSuffix>Multi Symptom Cold Flu Relief</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen,dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060629</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
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