{
"NDC": [
{
"NDCCode": "52817-835-30",
"PackageDescription": "1 TUBE in 1 CARTON (52817-835-30) / 30 g in 1 TUBE",
"NDC11Code": "52817-0835-30",
"ProductNDC": "52817-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "OINTMENT",
"RouteName": "RECTAL",
"StartMarketingDate": "20241202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212222",
"LabelerName": "Trupharma, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241202",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin ointment, 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.",
"Description": "Nitroglycerin is 1,2,3,-propanetriol trinitrate, an organic nitrate whose structural formula is as follows. and whose molecular weight is 227.09. Nitroglycerin ointment, USP, 0.4% contains 0.4% nitroglycerin w/w (4 mg nitroglycerin/1 g ointment), propylene glycol, lanolin, sorbitan sesquioleate, paraffin wax, and white petrolatum. Nitroglycerin ointment, USP, 0.4% is available in tubes with a one-inch dosing line on the carton allowing the measurement of approximately 375 mg of nitroglycerin ointment 0.4% (1.5 mg nitroglycerin) for application."
},
{
"NDCCode": "52817-117-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (52817-117-30) ",
"NDC11Code": "52817-0117-30",
"ProductNDC": "52817-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primidone",
"NonProprietaryName": "Primidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214896",
"LabelerName": "TruPharma LLC.",
"SubstanceName": "PRIMIDONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230221",
"SamplePackage": "N",
"IndicationAndUsage": "Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.",
"Description": "Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula. Primidone is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Primidone Tablets, USP 50 mg, 125 mg and 250 mg contain the following inactive ingredients: lactose monohydrate, NF; magnesium stearate, NF; hypromellose, USP; microcrystalline cellulose, NF; purified water, USP; sodium lauryl sulfate, NF; sodium starch glycolate, NF; and talc, USP/NF. _____________________________________________________________________________________________________."
},
{
"NDCCode": "52817-235-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-30) ",
"NDC11Code": "52817-0235-30",
"ProductNDC": "52817-235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramelteon",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212650",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200630",
"SamplePackage": "N",
"IndicationAndUsage": "Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].",
"Description": "Ramelteon Tablets are an orally active hypnotic chemically designated as ( S)- N-[2-(1,6,7,8-tetrahydro-2 H-indeno-[5,4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C 16H 21NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon Tablet includes the following inactive ingredients: lactose monohydrate, pregelatinized starch, hydroxypropyl cellulose, crospovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc and iron oxide yellow."
},
{
"NDCCode": "52817-240-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (52817-240-30) ",
"NDC11Code": "52817-0240-30",
"ProductNDC": "52817-240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine Extended Release",
"NonProprietaryName": "Lamotrigine Extended Release",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202887",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170605",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2) .",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg, white to off-white, round, film-coated tablets; 50 mg, peach, round, film-coated tablets; 100 mg, yellow, round, film-coated tablets; and 200 mg, blue, round, film-coated tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; mannitol; methacrylic acid copolymer; polyethylene glycol; polyvinyl alcohol; talc; titanium dioxide; triethyl citrate; black iron oxide (200 mg only); D&C yellow #10 aluminum lake (100 mg only); FD&C Blue #1 aluminum lake (200 mg only); FD&C yellow #6 aluminum lake (100 mg only); iron oxide red (50 mg only); and yellow iron oxide (50 mg only).Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Lamotrigine extended-release tablets, USP contain a modified-release core coated with an enteric coating layer embedded with a water soluble ingredient (“pore forming agent”) to enable a controlled release of the drug in the acidic environment of the stomach. The combination of the enteric coating layer and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
},
{
"NDCCode": "52817-241-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (52817-241-30) ",
"NDC11Code": "52817-0241-30",
"ProductNDC": "52817-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine Extended Release",
"NonProprietaryName": "Lamotrigine Extended Release",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202887",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170605",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2) .",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg, white to off-white, round, film-coated tablets; 50 mg, peach, round, film-coated tablets; 100 mg, yellow, round, film-coated tablets; and 200 mg, blue, round, film-coated tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; mannitol; methacrylic acid copolymer; polyethylene glycol; polyvinyl alcohol; talc; titanium dioxide; triethyl citrate; black iron oxide (200 mg only); D&C yellow #10 aluminum lake (100 mg only); FD&C Blue #1 aluminum lake (200 mg only); FD&C yellow #6 aluminum lake (100 mg only); iron oxide red (50 mg only); and yellow iron oxide (50 mg only).Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Lamotrigine extended-release tablets, USP contain a modified-release core coated with an enteric coating layer embedded with a water soluble ingredient (“pore forming agent”) to enable a controlled release of the drug in the acidic environment of the stomach. The combination of the enteric coating layer and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
},
{
"NDCCode": "52817-242-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (52817-242-30) ",
"NDC11Code": "52817-0242-30",
"ProductNDC": "52817-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine Extended Release",
"NonProprietaryName": "Lamotrigine Extended Release",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202887",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170605",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2) .",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg, white to off-white, round, film-coated tablets; 50 mg, peach, round, film-coated tablets; 100 mg, yellow, round, film-coated tablets; and 200 mg, blue, round, film-coated tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; mannitol; methacrylic acid copolymer; polyethylene glycol; polyvinyl alcohol; talc; titanium dioxide; triethyl citrate; black iron oxide (200 mg only); D&C yellow #10 aluminum lake (100 mg only); FD&C Blue #1 aluminum lake (200 mg only); FD&C yellow #6 aluminum lake (100 mg only); iron oxide red (50 mg only); and yellow iron oxide (50 mg only).Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Lamotrigine extended-release tablets, USP contain a modified-release core coated with an enteric coating layer embedded with a water soluble ingredient (“pore forming agent”) to enable a controlled release of the drug in the acidic environment of the stomach. The combination of the enteric coating layer and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
},
{
"NDCCode": "52817-243-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (52817-243-30) ",
"NDC11Code": "52817-0243-30",
"ProductNDC": "52817-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine Extended Release",
"NonProprietaryName": "Lamotrigine Extended Release",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202887",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170605",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2) .",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg, white to off-white, round, film-coated tablets; 50 mg, peach, round, film-coated tablets; 100 mg, yellow, round, film-coated tablets; and 200 mg, blue, round, film-coated tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; mannitol; methacrylic acid copolymer; polyethylene glycol; polyvinyl alcohol; talc; titanium dioxide; triethyl citrate; black iron oxide (200 mg only); D&C yellow #10 aluminum lake (100 mg only); FD&C Blue #1 aluminum lake (200 mg only); FD&C yellow #6 aluminum lake (100 mg only); iron oxide red (50 mg only); and yellow iron oxide (50 mg only).Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Lamotrigine extended-release tablets, USP contain a modified-release core coated with an enteric coating layer embedded with a water soluble ingredient (“pore forming agent”) to enable a controlled release of the drug in the acidic environment of the stomach. The combination of the enteric coating layer and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels."
},
{
"NDCCode": "52817-268-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-268-30) ",
"NDC11Code": "52817-0268-30",
"ProductNDC": "52817-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075643",
"LabelerName": "TruPharma LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250307",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 2.5 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg tablets also contain FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow # 6/Sunset Yellow FCF aluminum lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "52817-270-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30) ",
"NDC11Code": "52817-0270-30",
"ProductNDC": "52817-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075474",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190620",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "52817-271-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-271-30) ",
"NDC11Code": "52817-0271-30",
"ProductNDC": "52817-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075474",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190620",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "52817-340-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-340-30) ",
"NDC11Code": "52817-0340-30",
"ProductNDC": "52817-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204882",
"LabelerName": "TruPharma LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180611",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium."
},
{
"NDCCode": "52817-341-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-341-30) ",
"NDC11Code": "52817-0341-30",
"ProductNDC": "52817-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204882",
"LabelerName": "TruPharma LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180611",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium."
},
{
"NDCCode": "52817-342-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52817-342-30) ",
"NDC11Code": "52817-0342-30",
"ProductNDC": "52817-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204882",
"LabelerName": "TruPharma LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180611",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium."
},
{
"NDCCode": "52817-345-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-345-30) ",
"NDC11Code": "52817-0345-30",
"ProductNDC": "52817-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211200",
"LabelerName": "TruPharma LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220127",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 the treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: alcohol, ethylcellulose, hydrochloric acid, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, povidone, purified water, silicon dioxide, stearic acid and talc. The tablets are printed with edible black ink, which contains ferrosoferric oxide, hypromellose, propylene glycol, and purified water. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. FDA approved dissolution test specifications differ from the USP."
},
{
"NDCCode": "52817-346-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-346-30) ",
"NDC11Code": "52817-0346-30",
"ProductNDC": "52817-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211200",
"LabelerName": "TruPharma LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220127",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 the treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: alcohol, ethylcellulose, hydrochloric acid, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, povidone, purified water, silicon dioxide, stearic acid and talc. The tablets are printed with edible black ink, which contains ferrosoferric oxide, hypromellose, propylene glycol, and purified water. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. FDA approved dissolution test specifications differ from the USP."
},
{
"NDCCode": "52817-375-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52817-375-30) ",
"NDC11Code": "52817-0375-30",
"ProductNDC": "52817-375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine",
"NonProprietaryName": "Clonidine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240111",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022500",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "CLONIDINE",
"StrengthNumber": ".17",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240111",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine extended-release tablets are indicated in the treatment of hypertension. Clonidine extended-release tablets may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine extended-release tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively. Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. C 9H 9C l2N 3·HCl Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol. The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose, polyethylene glycol, and titanium dioxide. The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide."
},
{
"NDCCode": "52817-800-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (52817-800-30) / 30 mL in 1 BOTTLE",
"NDC11Code": "52817-0800-30",
"ProductNDC": "52817-800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole Topical Solution Usp, 1%",
"NonProprietaryName": "Clotrimazole Topical Solution Usp, 1%",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212281",
"LabelerName": "TruPharma LLC",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190725",
"SamplePackage": "N",
"IndicationAndUsage": "Prescription clotrimazole topical solution product is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton fluoccosum, and Microsporum canis.",
"Description": "Clotrimazole topical solution USP, 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following strctural formula. MOLECULAR FORMULA C 22H 17CIN 2 MOLECULAR WEIGHT 344.85 Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol, and chloroform. Each mL of clotrimazole topical solution USP, 1% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400."
},
{
"NDCCode": "52817-811-30",
"PackageDescription": "1 TUBE in 1 CARTON (52817-811-30) > 30 g in 1 TUBE",
"NDC11Code": "52817-0811-30",
"ProductNDC": "52817-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040671",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220210",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone acetonide cream, USP 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti‑inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4‑diene-3,20-dione cyclic 16,17-acetal with acetone. Structural formula. C24H31FO6 MW 434.50. Each gram of 0.1% triamcinolone acetonide cream, USP provides 1 mg of triamcinolone acetonide, USP in a cream base containing cetyl alcohol, isopropyl palmitate, methylparaben, mineral oil/lanolin alcohol, polysorbate 40, propylparaben, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol and xanthan gum."
},
{
"NDCCode": "52817-850-30",
"PackageDescription": "30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30) ",
"NDC11Code": "52817-0850-30",
"ProductNDC": "52817-850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sapropterin Dihydrochloride",
"NonProprietaryName": "Sapropterin Dihydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216432",
"LabelerName": "TRUPHARMA, LLC",
"SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
"IndicationAndUsage": "Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet.",
"Description": "Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Sapropterin dihydrochloride powder for oral solution is off-white to pale yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose."
},
{
"NDCCode": "52817-851-30",
"PackageDescription": "30 POWDER, FOR SOLUTION in 1 CARTON (52817-851-30) ",
"NDC11Code": "52817-0851-30",
"ProductNDC": "52817-851",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sapropterin Dihydrochloride",
"NonProprietaryName": "Sapropterin Dihydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216432",
"LabelerName": "TRUPHARMA, LLC",
"SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
"IndicationAndUsage": "Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet.",
"Description": "Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Sapropterin dihydrochloride powder for oral solution is off-white to pale yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose."
},
{
"NDCCode": "59088-767-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-767-00) * 1 TUBE in 1 CARTON (0591-2070-30) / 30 g in 1 TUBE * 100 TABLET, FILM COATED in 1 BOTTLE (52817-330-10) ",
"NDC11Code": "59088-0767-00",
"ProductNDC": "59088-767",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclopak",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride Tablet , Lidocaine And Prilocaine,",
"DosageFormName": "KIT",
"StartMarketingDate": "20201130",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201130",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N"
},
{
"NDCCode": "16590-835-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-835-30)",
"NDC11Code": "16590-0835-30",
"ProductNDC": "16590-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078206",
"LabelerName": "STAT RX LLC USA",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.",
"Description": "Oxycodone Hydrochloride Tablets USP are an opioid analgesic. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. OXYCODONE STRUCTURE IMAGE. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, stearic acid, DandC Yellow No. 10 (15 mg tablet), and FDandC Blue No. 2 (15 mg and 30 mg tablets). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "21695-835-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-835-30)",
"NDC11Code": "21695-0835-30",
"ProductNDC": "21695-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077050",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. 2. Prevention of nausea and vomiting associated with initial and repeat course of moderately emetogenic cancer chemotherapy. 3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.",
"Description": "The active ingredient in ondansetron tablets is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch, hypromellose, magnesium stearate, titanium dioxide, and polyethylene glycol 400. Ondansetron tablet 8 mg also contains polysorbate 80 and iron oxide yellow."
},
{
"NDCCode": "33261-835-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-835-30)",
"NDC11Code": "33261-0835-30",
"ProductNDC": "33261-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizideer",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20031107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076467",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-Cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide. Each tablet contains the following inactive ingredients: acetyltributyl citrate, edible black ink, hydroxyethyl cellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type A and polyethylene glycol. The 2.5 mg and 5 mg tablets also contain FD&C Yellow #6."
},
{
"NDCCode": "35356-835-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (35356-835-30) ",
"NDC11Code": "35356-0835-30",
"ProductNDC": "35356-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006134",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080101",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "42507-835-30",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (42507-835-30) / 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "42507-0835-30",
"ProductNDC": "42507-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyvee Extra Strength Gas Relief Softgel",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20260820",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "HyVee Inc",
"SubstanceName": "DIMETHICONE, UNSPECIFIED",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260820",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief of pressure, bloating, and fullness commonly referred to as gas."
},
{
"NDCCode": "43063-835-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-30) ",
"NDC11Code": "43063-0835-30",
"ProductNDC": "43063-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203512",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180213",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone is an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosternism for: ( 1.4) Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.",
"Description": "Spironolactone oral tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths."
},
{
"NDCCode": "47335-835-83",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-83) ",
"NDC11Code": "47335-0835-83",
"ProductNDC": "47335-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine Hydrobromide",
"NonProprietaryName": "Galantamine Hydrobromide",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090178",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110209",
"SamplePackage": "N",
"IndicationAndUsage": "Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.",
"Description": "Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "49035-835-30",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (49035-835-30)",
"NDC11Code": "49035-0835-30",
"ProductNDC": "49035-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Anti Bacterial",
"ProprietaryNameSuffix": "Hand Sanitizer Beach",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wal-Mart Stores Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "■ For handwashing to decrease bacteria on the skin. ■ Recommended for repeated use."
},
{
"NDCCode": "49999-835-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (49999-835-30)",
"NDC11Code": "49999-0835-30",
"ProductNDC": "49999-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078273",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-01-02"
}
]
}
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<NDCList>
<NDC>
<NDCCode>52817-835-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52817-835-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>52817-0835-30</NDC11Code>
<ProductNDC>52817-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20241202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212222</ApplicationNumber>
<LabelerName>Trupharma, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin ointment, 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3,-propanetriol trinitrate, an organic nitrate whose structural formula is as follows. and whose molecular weight is 227.09. Nitroglycerin ointment, USP, 0.4% contains 0.4% nitroglycerin w/w (4 mg nitroglycerin/1 g ointment), propylene glycol, lanolin, sorbitan sesquioleate, paraffin wax, and white petrolatum. Nitroglycerin ointment, USP, 0.4% is available in tubes with a one-inch dosing line on the carton allowing the measurement of approximately 375 mg of nitroglycerin ointment 0.4% (1.5 mg nitroglycerin) for application.</Description>
</NDC>
<NDC>
<NDCCode>52817-117-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52817-117-30) </PackageDescription>
<NDC11Code>52817-0117-30</NDC11Code>
<ProductNDC>52817-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primidone</ProprietaryName>
<NonProprietaryName>Primidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214896</ApplicationNumber>
<LabelerName>TruPharma LLC.</LabelerName>
<SubstanceName>PRIMIDONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.</IndicationAndUsage>
<Description>Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula. Primidone is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Primidone Tablets, USP 50 mg, 125 mg and 250 mg contain the following inactive ingredients: lactose monohydrate, NF; magnesium stearate, NF; hypromellose, USP; microcrystalline cellulose, NF; purified water, USP; sodium lauryl sulfate, NF; sodium starch glycolate, NF; and talc, USP/NF. _____________________________________________________________________________________________________.</Description>
</NDC>
<NDC>
<NDCCode>52817-235-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-30) </PackageDescription>
<NDC11Code>52817-0235-30</NDC11Code>
<ProductNDC>52817-235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramelteon</ProprietaryName>
<NonProprietaryName>Ramelteon</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212650</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>RAMELTEON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramelteon Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Ramelteon Tablets are an orally active hypnotic chemically designated as ( S)- N-[2-(1,6,7,8-tetrahydro-2 H-indeno-[5,4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C 16H 21NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon Tablet includes the following inactive ingredients: lactose monohydrate, pregelatinized starch, hydroxypropyl cellulose, crospovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>52817-240-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52817-240-30) </PackageDescription>
<NDC11Code>52817-0240-30</NDC11Code>
<ProductNDC>52817-240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine Extended Release</ProprietaryName>
<NonProprietaryName>Lamotrigine Extended Release</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202887</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg, white to off-white, round, film-coated tablets; 50 mg, peach, round, film-coated tablets; 100 mg, yellow, round, film-coated tablets; and 200 mg, blue, round, film-coated tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; mannitol; methacrylic acid copolymer; polyethylene glycol; polyvinyl alcohol; talc; titanium dioxide; triethyl citrate; black iron oxide (200 mg only); D&C yellow #10 aluminum lake (100 mg only); FD&C Blue #1 aluminum lake (200 mg only); FD&C yellow #6 aluminum lake (100 mg only); iron oxide red (50 mg only); and yellow iron oxide (50 mg only).Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Lamotrigine extended-release tablets, USP contain a modified-release core coated with an enteric coating layer embedded with a water soluble ingredient (“pore forming agent”) to enable a controlled release of the drug in the acidic environment of the stomach. The combination of the enteric coating layer and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
<NDC>
<NDCCode>52817-241-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52817-241-30) </PackageDescription>
<NDC11Code>52817-0241-30</NDC11Code>
<ProductNDC>52817-241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine Extended Release</ProprietaryName>
<NonProprietaryName>Lamotrigine Extended Release</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202887</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg, white to off-white, round, film-coated tablets; 50 mg, peach, round, film-coated tablets; 100 mg, yellow, round, film-coated tablets; and 200 mg, blue, round, film-coated tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; mannitol; methacrylic acid copolymer; polyethylene glycol; polyvinyl alcohol; talc; titanium dioxide; triethyl citrate; black iron oxide (200 mg only); D&C yellow #10 aluminum lake (100 mg only); FD&C Blue #1 aluminum lake (200 mg only); FD&C yellow #6 aluminum lake (100 mg only); iron oxide red (50 mg only); and yellow iron oxide (50 mg only).Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Lamotrigine extended-release tablets, USP contain a modified-release core coated with an enteric coating layer embedded with a water soluble ingredient (“pore forming agent”) to enable a controlled release of the drug in the acidic environment of the stomach. The combination of the enteric coating layer and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
<NDC>
<NDCCode>52817-242-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52817-242-30) </PackageDescription>
<NDC11Code>52817-0242-30</NDC11Code>
<ProductNDC>52817-242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine Extended Release</ProprietaryName>
<NonProprietaryName>Lamotrigine Extended Release</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202887</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg, white to off-white, round, film-coated tablets; 50 mg, peach, round, film-coated tablets; 100 mg, yellow, round, film-coated tablets; and 200 mg, blue, round, film-coated tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; mannitol; methacrylic acid copolymer; polyethylene glycol; polyvinyl alcohol; talc; titanium dioxide; triethyl citrate; black iron oxide (200 mg only); D&C yellow #10 aluminum lake (100 mg only); FD&C Blue #1 aluminum lake (200 mg only); FD&C yellow #6 aluminum lake (100 mg only); iron oxide red (50 mg only); and yellow iron oxide (50 mg only).Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Lamotrigine extended-release tablets, USP contain a modified-release core coated with an enteric coating layer embedded with a water soluble ingredient (“pore forming agent”) to enable a controlled release of the drug in the acidic environment of the stomach. The combination of the enteric coating layer and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
<NDC>
<NDCCode>52817-243-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52817-243-30) </PackageDescription>
<NDC11Code>52817-0243-30</NDC11Code>
<ProductNDC>52817-243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine Extended Release</ProprietaryName>
<NonProprietaryName>Lamotrigine Extended Release</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202887</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine extended-release tablets are indicated for: : 1 adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) , 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. ( 1.2) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C 9H 7N 5Cl 2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg, white to off-white, round, film-coated tablets; 50 mg, peach, round, film-coated tablets; 100 mg, yellow, round, film-coated tablets; and 200 mg, blue, round, film-coated tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; mannitol; methacrylic acid copolymer; polyethylene glycol; polyvinyl alcohol; talc; titanium dioxide; triethyl citrate; black iron oxide (200 mg only); D&C yellow #10 aluminum lake (100 mg only); FD&C Blue #1 aluminum lake (200 mg only); FD&C yellow #6 aluminum lake (100 mg only); iron oxide red (50 mg only); and yellow iron oxide (50 mg only).Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Lamotrigine extended-release tablets, USP contain a modified-release core coated with an enteric coating layer embedded with a water soluble ingredient (“pore forming agent”) to enable a controlled release of the drug in the acidic environment of the stomach. The combination of the enteric coating layer and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
</NDC>
<NDC>
<NDCCode>52817-268-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-268-30) </PackageDescription>
<NDC11Code>52817-0268-30</NDC11Code>
<ProductNDC>52817-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075643</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 2.5 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg tablets also contain FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow # 6/Sunset Yellow FCF aluminum lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>52817-270-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30) </PackageDescription>
<NDC11Code>52817-0270-30</NDC11Code>
<ProductNDC>52817-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075474</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52817-271-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-271-30) </PackageDescription>
<NDC11Code>52817-0271-30</NDC11Code>
<ProductNDC>52817-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075474</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta1-selective (cardio-selective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C 18H 31NO 4) 2C 4H 4O 4and its structure is:. Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol and chloroform. Bisoprolol fumarate is available as 5 mg or 10 mg for oral administration. Inactive ingredients include carnauba wax, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52817-340-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-340-30) </PackageDescription>
<NDC11Code>52817-0340-30</NDC11Code>
<ProductNDC>52817-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204882</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium.</Description>
</NDC>
<NDC>
<NDCCode>52817-341-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-341-30) </PackageDescription>
<NDC11Code>52817-0341-30</NDC11Code>
<ProductNDC>52817-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204882</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium.</Description>
</NDC>
<NDC>
<NDCCode>52817-342-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52817-342-30) </PackageDescription>
<NDC11Code>52817-0342-30</NDC11Code>
<ProductNDC>52817-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204882</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium.</Description>
</NDC>
<NDC>
<NDCCode>52817-345-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-345-30) </PackageDescription>
<NDC11Code>52817-0345-30</NDC11Code>
<ProductNDC>52817-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211200</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 the treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: alcohol, ethylcellulose, hydrochloric acid, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, povidone, purified water, silicon dioxide, stearic acid and talc. The tablets are printed with edible black ink, which contains ferrosoferric oxide, hypromellose, propylene glycol, and purified water. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. FDA approved dissolution test specifications differ from the USP.</Description>
</NDC>
<NDC>
<NDCCode>52817-346-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-346-30) </PackageDescription>
<NDC11Code>52817-0346-30</NDC11Code>
<ProductNDC>52817-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211200</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 the treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 300 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: alcohol, ethylcellulose, hydrochloric acid, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, povidone, purified water, silicon dioxide, stearic acid and talc. The tablets are printed with edible black ink, which contains ferrosoferric oxide, hypromellose, propylene glycol, and purified water. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. FDA approved dissolution test specifications differ from the USP.</Description>
</NDC>
<NDC>
<NDCCode>52817-375-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52817-375-30) </PackageDescription>
<NDC11Code>52817-0375-30</NDC11Code>
<ProductNDC>52817-375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine</ProprietaryName>
<NonProprietaryName>Clonidine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240111</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022500</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>CLONIDINE</SubstanceName>
<StrengthNumber>.17</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine extended-release tablets are indicated in the treatment of hypertension. Clonidine extended-release tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine extended-release tablets are available for oral administration in two dose strengths: 0.17 mg and 0.26 mg. The 0.17 mg and 0.26 mg tablets are equivalent to 0.2 mg and 0.3 mg of immediate-release clonidine hydrochloride, respectively. Clonidine hydrochloride, a centrally active alpha-adrenergic agonist, is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2.6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. C 9H 9C l2N 3·HCl Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol. The inactive ingredients are: crospovidone, dental-type silica, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium polystyrene sulfonate, triacetin. The 0.17 mg tablet also contains hypromellose, polyethylene glycol, and titanium dioxide. The 0.26 mg tablet also contains D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, fractionated coconut oil, maltodextrin, polydextrose, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52817-800-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52817-800-30) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>52817-0800-30</NDC11Code>
<ProductNDC>52817-800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole Topical Solution Usp, 1%</ProprietaryName>
<NonProprietaryName>Clotrimazole Topical Solution Usp, 1%</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212281</ApplicationNumber>
<LabelerName>TruPharma LLC</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prescription clotrimazole topical solution product is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur. This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton fluoccosum, and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole topical solution USP, 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following strctural formula. MOLECULAR FORMULA C 22H 17CIN 2 MOLECULAR WEIGHT 344.85 Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol, and chloroform. Each mL of clotrimazole topical solution USP, 1% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400.</Description>
</NDC>
<NDC>
<NDCCode>52817-811-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (52817-811-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>52817-0811-30</NDC11Code>
<ProductNDC>52817-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040671</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone acetonide cream, USP 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti‑inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4‑diene-3,20-dione cyclic 16,17-acetal with acetone. Structural formula. C24H31FO6 MW 434.50. Each gram of 0.1% triamcinolone acetonide cream, USP provides 1 mg of triamcinolone acetonide, USP in a cream base containing cetyl alcohol, isopropyl palmitate, methylparaben, mineral oil/lanolin alcohol, polysorbate 40, propylparaben, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>52817-850-30</NDCCode>
<PackageDescription>30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30) </PackageDescription>
<NDC11Code>52817-0850-30</NDC11Code>
<ProductNDC>52817-850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sapropterin Dihydrochloride</ProprietaryName>
<NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216432</ApplicationNumber>
<LabelerName>TRUPHARMA, LLC</LabelerName>
<SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet.</IndicationAndUsage>
<Description>Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Sapropterin dihydrochloride powder for oral solution is off-white to pale yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>52817-851-30</NDCCode>
<PackageDescription>30 POWDER, FOR SOLUTION in 1 CARTON (52817-851-30) </PackageDescription>
<NDC11Code>52817-0851-30</NDC11Code>
<ProductNDC>52817-851</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sapropterin Dihydrochloride</ProprietaryName>
<NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216432</ApplicationNumber>
<LabelerName>TRUPHARMA, LLC</LabelerName>
<SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sapropterin dihydrochloride powder for oral solution is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet.</IndicationAndUsage>
<Description>Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9H 15N 5O 3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base). Sapropterin dihydrochloride powder for oral solution is off-white to pale yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>59088-767-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-767-00) * 1 TUBE in 1 CARTON (0591-2070-30) / 30 g in 1 TUBE * 100 TABLET, FILM COATED in 1 BOTTLE (52817-330-10) </PackageDescription>
<NDC11Code>59088-0767-00</NDC11Code>
<ProductNDC>59088-767</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclopak</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride Tablet , Lidocaine And Prilocaine,</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20201130</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201130</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-835-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-835-30)</PackageDescription>
<NDC11Code>16590-0835-30</NDC11Code>
<ProductNDC>16590-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078206</ApplicationNumber>
<LabelerName>STAT RX LLC USA</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets USP are an opioid analgesic. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. OXYCODONE STRUCTURE IMAGE. The tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, stearic acid, DandC Yellow No. 10 (15 mg tablet), and FDandC Blue No. 2 (15 mg and 30 mg tablets). The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>21695-835-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-835-30)</PackageDescription>
<NDC11Code>21695-0835-30</NDC11Code>
<ProductNDC>21695-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077050</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. 2. Prevention of nausea and vomiting associated with initial and repeat course of moderately emetogenic cancer chemotherapy. 3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch, hypromellose, magnesium stearate, titanium dioxide, and polyethylene glycol 400. Ondansetron tablet 8 mg also contains polysorbate 80 and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>33261-835-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-835-30)</PackageDescription>
<NDC11Code>33261-0835-30</NDC11Code>
<ProductNDC>33261-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizideer</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076467</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-Cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide. Each tablet contains the following inactive ingredients: acetyltributyl citrate, edible black ink, hydroxyethyl cellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type A and polyethylene glycol. The 2.5 mg and 5 mg tablets also contain FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>35356-835-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (35356-835-30) </PackageDescription>
<NDC11Code>35356-0835-30</NDC11Code>
<ProductNDC>35356-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080101</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006134</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080101</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42507-835-30</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (42507-835-30) / 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42507-0835-30</NDC11Code>
<ProductNDC>42507-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyvee Extra Strength Gas Relief Softgel</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260820</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>HyVee Inc</LabelerName>
<SubstanceName>DIMETHICONE, UNSPECIFIED</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief of pressure, bloating, and fullness commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-835-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-30) </PackageDescription>
<NDC11Code>43063-0835-30</NDC11Code>
<ProductNDC>43063-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203512</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosternism for: ( 1.4) Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
<Description>Spironolactone oral tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.</Description>
</NDC>
<NDC>
<NDCCode>47335-835-83</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-83) </PackageDescription>
<NDC11Code>47335-0835-83</NDC11Code>
<ProductNDC>47335-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
<NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090178</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>49035-835-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (49035-835-30)</PackageDescription>
<NDC11Code>49035-0835-30</NDC11Code>
<ProductNDC>49035-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Anti Bacterial</ProprietaryName>
<ProprietaryNameSuffix>Hand Sanitizer Beach</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Wal-Mart Stores Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>■ For handwashing to decrease bacteria on the skin. ■ Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49999-835-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (49999-835-30)</PackageDescription>
<NDC11Code>49999-0835-30</NDC11Code>
<ProductNDC>49999-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078273</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-01-02</LastUpdate>
</NDC>
</NDCList>