{
"NDC": [
{
"NDCCode": "53041-527-06",
"PackageDescription": "473 mL in 1 BOTTLE (53041-527-06) ",
"NDC11Code": "53041-0527-06",
"ProductNDC": "53041-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pink-bismuth",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080530",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms."
},
{
"NDCCode": "53041-660-06",
"PackageDescription": "473 mL in 1 BOTTLE (53041-660-06) ",
"NDC11Code": "53041-0660-06",
"ProductNDC": "53041-660",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218080",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251202",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2).",
"Description": "Levetiracetam oral solution, USP is an antiepileptic drug available as a clear, colorless to pale yellow, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white powder with a faint odor and a bitter taste. It is very soluble in water and acetonitrile and practically insoluble in hexane. Levetiracetam oral solution, USP contains 100 mg of levetiracetam, USP per mL. Inactive ingredients: acesulfame potassium, anhydrous citric acid, artificial grape flavor, glycerin, magnasweet, maltitol, methylparaben, propylparaben, purified water, sodium citrate dihydrate."
},
{
"NDCCode": "53041-680-06",
"PackageDescription": "473 mL in 1 BOTTLE (53041-680-06) ",
"NDC11Code": "53041-0680-06",
"ProductNDC": "53041-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214892",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "meq/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210709",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium Chloride is a white to almost white crystalline powder or colorless crystals. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution: 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "53041-681-06",
"PackageDescription": "473 mL in 1 BOTTLE (53041-681-06) ",
"NDC11Code": "53041-0681-06",
"ProductNDC": "53041-681",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20210709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214892",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "meq/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210709",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium Chloride is a white to almost white crystalline powder or colorless crystals. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution: 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "53041-527-03",
"PackageDescription": "118 mL in 1 BOTTLE (53041-527-03) ",
"NDC11Code": "53041-0527-03",
"ProductNDC": "53041-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pink-bismuth",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080530",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms."
},
{
"NDCCode": "53041-527-04",
"PackageDescription": "236 mL in 1 BOTTLE (53041-527-04) ",
"NDC11Code": "53041-0527-04",
"ProductNDC": "53041-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pink-bismuth",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080530",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms."
},
{
"NDCCode": "53041-527-05",
"PackageDescription": "354 mL in 1 BOTTLE (53041-527-05) ",
"NDC11Code": "53041-0527-05",
"ProductNDC": "53041-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pink-bismuth",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080530",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms."
},
{
"NDCCode": "68180-527-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68180-527-06) ",
"NDC11Code": "68180-0527-06",
"ProductNDC": "68180-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202782",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151221",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablet is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil Hydrochloride Tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients in 23 mg tablets include colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium starch glycolate. The film coating includes hypromellose, iron oxide red, polyethylene glycol, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "68382-527-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68382-527-06) ",
"NDC11Code": "68382-0527-06",
"ProductNDC": "68382-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202900",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula."
},
{
"NDCCode": "68428-527-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-527-06) ",
"NDC11Code": "68428-0527-06",
"ProductNDC": "68428-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Phosphoricum",
"NonProprietaryName": "Sodium Phosphate, Dibasic Anhydrous",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "69842-527-06",
"PackageDescription": "473 mL in 1 BOTTLE (69842-527-06)",
"NDC11Code": "69842-0527-06",
"ProductNDC": "69842-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080908",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "CVS",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms."
},
{
"NDCCode": "72476-527-06",
"PackageDescription": "473 mL in 1 BOTTLE (72476-527-06) ",
"NDC11Code": "72476-0527-06",
"ProductNDC": "72476-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Regular Strength Stomach Relief",
"NonProprietaryName": "Bismuth Subsalicylate 525 Mg",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250721",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "Retail Business Services, LLC.",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/30mL",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250721",
"SamplePackage": "N",
"IndicationAndUsage": "relieves."
},
{
"NDCCode": "82442-527-06",
"PackageDescription": "473 mL in 1 BOTTLE (82442-527-06) ",
"NDC11Code": "82442-0527-06",
"ProductNDC": "82442-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up 5 Symptoms Digestive Relief 527",
"NonProprietaryName": "Bismuth Subsalicylate 525 Mg",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240618",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part335",
"LabelerName": "Target corporation",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Bismuth [CS], Bismuth [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240618",
"SamplePackage": "N",
"IndicationAndUsage": "relieves."
},
{
"NDCCode": "53041-022-49",
"PackageDescription": "5 BLISTER PACK in 1 BOX (53041-022-49) / 6 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "53041-0022-49",
"ProductNDC": "53041-022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guardian Pink-bismuth Cherry",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20231204",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part335",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231204",
"SamplePackage": "N",
"IndicationAndUsage": "relieves."
},
{
"NDCCode": "53041-184-22",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (53041-184-22) ",
"NDC11Code": "53041-0184-22",
"ProductNDC": "53041-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guardian Extra Strength Assorted Berry Antacid",
"ProprietaryNameSuffix": "Extra Strength Assorted Berry Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part331",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "53041-263-50",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (53041-263-50) > 6 TABLET in 1 BLISTER PACK",
"NDC11Code": "53041-0263-50",
"ProductNDC": "53041-263",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loperamide Hydrochloride, Simethicone",
"NonProprietaryName": "Loperamide Hydrochloride, Simethicone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214541",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"StrengthNumber": "2; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2021-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas."
},
{
"NDCCode": "0990-4179-05",
"PackageDescription": "6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG",
"NDC11Code": "00990-4179-05",
"ProductNDC": "0990-4179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn-pf",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019492",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; PROLINE; SERINE; TAURINE; TYROSINE",
"StrengthNumber": "760; 1200; 677; 180; 427; 512; 180; 673; 698; 1227; 527; 820; 385; 312; 812; 495; 70; 44",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N",
"IndicationAndUsage": "Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 10% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information. Central Venous Infusion. Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants or those requiring long-term parenteral nutrition. Peripheral Parenteral Nutrition. For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.",
"Description": "Aminosyn®-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-PF 10% is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulation is described below. The formulas for the individual amino acids present in Aminosyn-PF 10% are as follows:. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture."
},
{
"NDCCode": "16729-098-05",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-098-05) > 16.7 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "16729-0098-05",
"ProductNDC": "16729-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205720",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumors. (see CLINICAL STUDIES: Breast Carcinoma.). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP in combination with cisplatin, is indicated for the first-line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel USP, 527 mg of Kolliphor ®ELP (Polyoxyl 35 Castor Oil, NF) and 49.7% (v/v) dehydrated alcohol, USP. Paclitaxel is a semi-synthetic derivative of 10-Deacetylbaccatin-III, with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C."
},
{
"NDCCode": "16729-098-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-098-11) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "16729-0098-11",
"ProductNDC": "16729-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205720",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumors. (see CLINICAL STUDIES: Breast Carcinoma.). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP in combination with cisplatin, is indicated for the first-line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel USP, 527 mg of Kolliphor ®ELP (Polyoxyl 35 Castor Oil, NF) and 49.7% (v/v) dehydrated alcohol, USP. Paclitaxel is a semi-synthetic derivative of 10-Deacetylbaccatin-III, with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C."
},
{
"NDCCode": "16729-098-31",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-098-31) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "16729-0098-31",
"ProductNDC": "16729-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205720",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumors. (see CLINICAL STUDIES: Breast Carcinoma.). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP in combination with cisplatin, is indicated for the first-line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel USP, 527 mg of Kolliphor ®ELP (Polyoxyl 35 Castor Oil, NF) and 49.7% (v/v) dehydrated alcohol, USP. Paclitaxel is a semi-synthetic derivative of 10-Deacetylbaccatin-III, with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C."
},
{
"NDCCode": "42291-673-57",
"PackageDescription": "527 g in 1 BOTTLE (42291-673-57) ",
"NDC11Code": "42291-0673-57",
"ProductNDC": "42291-673",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polyethylene Glycol 3350",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20130705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076652",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130705",
"SamplePackage": "N"
},
{
"NDCCode": "43547-527-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-527-03) ",
"NDC11Code": "43547-0527-03",
"ProductNDC": "43547-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated 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. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "43547-527-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (43547-527-09) ",
"NDC11Code": "43547-0527-09",
"ProductNDC": "43547-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated 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. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "43547-527-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (43547-527-50) ",
"NDC11Code": "43547-0527-50",
"ProductNDC": "43547-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated 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. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "50242-120-47",
"PackageDescription": "1 KIT in 1 CARTON (50242-120-47) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06) / 10 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0120-47",
"ProductNDC": "50242-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tnkase",
"NonProprietaryName": "Tenecteplase",
"DosageFormName": "KIT",
"StartMarketingDate": "20181107",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103909",
"LabelerName": "Genentech, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181107",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "TNKase® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI).",
"Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
},
{
"NDCCode": "50242-176-01",
"PackageDescription": "1 KIT in 1 CARTON (50242-176-01) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06) / 10 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0176-01",
"ProductNDC": "50242-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tnkase",
"NonProprietaryName": "Tenecteplase",
"DosageFormName": "KIT",
"StartMarketingDate": "20240105",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103909",
"LabelerName": "Genentech, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240105",
"SamplePackage": "N",
"IndicationAndUsage": "TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).",
"Description": "Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."
},
{
"NDCCode": "50268-527-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-527-15) / 1 TABLET in 1 BLISTER PACK (50268-527-11) ",
"NDC11Code": "50268-0527-15",
"ProductNDC": "50268-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210040",
"LabelerName": "AvPAK",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210526",
"SamplePackage": "N",
"IndicationAndUsage": "Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: : 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1) , 2 Treatment of adults with mycosis fungoides. ( 1.1) , 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen. ( 1.1) , 4 Treatment of adults with rheumatoid arthritis. ( 1.2) , 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). ( 1.3) , 6 Treatment of adults with severe psoriasis. ( 1.4) .",
"Description": "Methotrexate, USP is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C 20H 22N 8O 5 and the molecular weight is 454.4 g/mol. The structural formula is:. Methotrexate tablets, USP for oral use are available in bottles of 36 and 100 tablets. Each methotrexate tablet, USP contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: lactose monohydrate, magnesium stearate and maize starch."
},
{
"NDCCode": "55801-527-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (55801-527-01) ",
"NDC11Code": "55801-0527-01",
"ProductNDC": "55801-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214908",
"LabelerName": "Appco Pharma LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210601",
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"IndicationAndUsage": "Doxepin hydrochloride capsules are recommended for the treatment of. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO HCl having a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and in methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3- dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin hydrochloride capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 25 mg, 50 mg, 75 mg, 100 mg empty gelatin capsule shells contain D&C Yellow No. 10. The 25 mg, 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6. The 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The 10 mg empty gelatin capsule shells contain Iron Oxide Yellow. The imprint ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "55801-527-02",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (55801-527-02) ",
"NDC11Code": "55801-0527-02",
"ProductNDC": "55801-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214908",
"LabelerName": "Appco Pharma LLC",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are recommended for the treatment of. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO HCl having a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and in methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3- dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin hydrochloride capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 25 mg, 50 mg, 75 mg, 100 mg empty gelatin capsule shells contain D&C Yellow No. 10. The 25 mg, 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6. The 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The 10 mg empty gelatin capsule shells contain Iron Oxide Yellow. The imprint ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "61269-527-98",
"PackageDescription": "1 BOTTLE in 1 CARTON (61269-527-98) / 237 mL in 1 BOTTLE",
"NDC11Code": "61269-0527-98",
"ProductNDC": "61269-527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Allergy",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220718",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203330",
"LabelerName": "H2-Pharma, LLC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
}
]
}
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<PackageDescription>473 mL in 1 BOTTLE (53041-660-06) </PackageDescription>
<NDC11Code>53041-0660-06</NDC11Code>
<ProductNDC>53041-660</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
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<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
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<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
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<Description>Levetiracetam oral solution, USP is an antiepileptic drug available as a clear, colorless to pale yellow, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white powder with a faint odor and a bitter taste. It is very soluble in water and acetonitrile and practically insoluble in hexane. Levetiracetam oral solution, USP contains 100 mg of levetiracetam, USP per mL. Inactive ingredients: acesulfame potassium, anhydrous citric acid, artificial grape flavor, glycerin, magnasweet, maltitol, methylparaben, propylparaben, purified water, sodium citrate dihydrate.</Description>
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<StrengthNumber>40</StrengthNumber>
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<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium Chloride is a white to almost white crystalline powder or colorless crystals. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution: 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
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<NDCCode>53041-681-06</NDCCode>
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<NDC11Code>53041-0681-06</NDC11Code>
<ProductNDC>53041-681</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
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<StrengthUnit>meq/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium Chloride is a white to almost white crystalline powder or colorless crystals. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution: 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
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<NDC>
<NDCCode>53041-527-03</NDCCode>
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<ProprietaryName>Pink-bismuth</ProprietaryName>
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<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms.</IndicationAndUsage>
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<NDCCode>53041-527-04</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (53041-527-04) </PackageDescription>
<NDC11Code>53041-0527-04</NDC11Code>
<ProductNDC>53041-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pink-bismuth</ProprietaryName>
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<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53041-527-05</NDCCode>
<PackageDescription>354 mL in 1 BOTTLE (53041-527-05) </PackageDescription>
<NDC11Code>53041-0527-05</NDC11Code>
<ProductNDC>53041-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pink-bismuth</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68180-527-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68180-527-06) </PackageDescription>
<NDC11Code>68180-0527-06</NDC11Code>
<ProductNDC>68180-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202782</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>23</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride tablet is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil Hydrochloride Tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients in 23 mg tablets include colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium starch glycolate. The film coating includes hypromellose, iron oxide red, polyethylene glycol, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>68382-527-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68382-527-06) </PackageDescription>
<NDC11Code>68382-0527-06</NDC11Code>
<ProductNDC>68382-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>68428-527-06</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-527-06) </PackageDescription>
<NDC11Code>68428-0527-06</NDC11Code>
<ProductNDC>68428-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natrum Phosphoricum</ProprietaryName>
<NonProprietaryName>Sodium Phosphate, Dibasic Anhydrous</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-527-06</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (69842-527-06)</PackageDescription>
<NDC11Code>69842-0527-06</NDC11Code>
<ProductNDC>69842-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080908</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>CVS</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves: : 1 diarrhea, 2 heartburn, 3 indigestion, 4 nausea, 5 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72476-527-06</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (72476-527-06) </PackageDescription>
<NDC11Code>72476-0527-06</NDC11Code>
<ProductNDC>72476-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Regular Strength Stomach Relief</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate 525 Mg</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250721</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>Retail Business Services, LLC.</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82442-527-06</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (82442-527-06) </PackageDescription>
<NDC11Code>82442-0527-06</NDC11Code>
<ProductNDC>82442-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up 5 Symptoms Digestive Relief 527</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate 525 Mg</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Target corporation</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Bismuth [CS], Bismuth [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53041-022-49</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 BOX (53041-022-49) / 6 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53041-0022-49</NDC11Code>
<ProductNDC>53041-022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guardian Pink-bismuth Cherry</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53041-184-22</NDCCode>
<PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE (53041-184-22) </PackageDescription>
<NDC11Code>53041-0184-22</NDC11Code>
<ProductNDC>53041-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guardian Extra Strength Assorted Berry Antacid</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Assorted Berry Antacid</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53041-263-50</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (53041-263-50) > 6 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53041-0263-50</NDC11Code>
<ProductNDC>53041-263</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loperamide Hydrochloride, Simethicone</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride, Simethicone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214541</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>2; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0990-4179-05</NDCCode>
<PackageDescription>6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-4179-05</NDC11Code>
<ProductNDC>0990-4179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn-pf</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019492</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; PROLINE; SERINE; TAURINE; TYROSINE</SubstanceName>
<StrengthNumber>760; 1200; 677; 180; 427; 512; 180; 673; 698; 1227; 527; 820; 385; 312; 812; 495; 70; 44</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 10% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information. Central Venous Infusion. Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants or those requiring long-term parenteral nutrition. Peripheral Parenteral Nutrition. For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.</IndicationAndUsage>
<Description>Aminosyn®-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-PF 10% is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulation is described below. The formulas for the individual amino acids present in Aminosyn-PF 10% are as follows:. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture.</Description>
</NDC>
<NDC>
<NDCCode>16729-098-05</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (16729-098-05) > 16.7 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>16729-0098-05</NDC11Code>
<ProductNDC>16729-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205720</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumors. (see CLINICAL STUDIES: Breast Carcinoma.). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP in combination with cisplatin, is indicated for the first-line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel USP, 527 mg of Kolliphor ®ELP (Polyoxyl 35 Castor Oil, NF) and 49.7% (v/v) dehydrated alcohol, USP. Paclitaxel is a semi-synthetic derivative of 10-Deacetylbaccatin-III, with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C.</Description>
</NDC>
<NDC>
<NDCCode>16729-098-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (16729-098-11) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>16729-0098-11</NDC11Code>
<ProductNDC>16729-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205720</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumors. (see CLINICAL STUDIES: Breast Carcinoma.). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP in combination with cisplatin, is indicated for the first-line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel USP, 527 mg of Kolliphor ®ELP (Polyoxyl 35 Castor Oil, NF) and 49.7% (v/v) dehydrated alcohol, USP. Paclitaxel is a semi-synthetic derivative of 10-Deacetylbaccatin-III, with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C.</Description>
</NDC>
<NDC>
<NDCCode>16729-098-31</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (16729-098-31) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>16729-0098-31</NDC11Code>
<ProductNDC>16729-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205720</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin. Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumors. (see CLINICAL STUDIES: Breast Carcinoma.). Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel Injection, USP in combination with cisplatin, is indicated for the first-line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel USP, 527 mg of Kolliphor ®ELP (Polyoxyl 35 Castor Oil, NF) and 49.7% (v/v) dehydrated alcohol, USP. Paclitaxel is a semi-synthetic derivative of 10-Deacetylbaccatin-III, with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3phenylisoserine. Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47H 51NO 14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C.</Description>
</NDC>
<NDC>
<NDCCode>42291-673-57</NDCCode>
<PackageDescription>527 g in 1 BOTTLE (42291-673-57) </PackageDescription>
<NDC11Code>42291-0673-57</NDC11Code>
<ProductNDC>42291-673</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076652</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43547-527-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-527-03) </PackageDescription>
<NDC11Code>43547-0527-03</NDC11Code>
<ProductNDC>43547-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated 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. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>43547-527-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43547-527-09) </PackageDescription>
<NDC11Code>43547-0527-09</NDC11Code>
<ProductNDC>43547-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated 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. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>43547-527-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43547-527-50) </PackageDescription>
<NDC11Code>43547-0527-50</NDC11Code>
<ProductNDC>43547-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated 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. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>50242-120-47</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-120-47) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06) / 10 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0120-47</NDC11Code>
<ProductNDC>50242-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tnkase</ProprietaryName>
<NonProprietaryName>Tenecteplase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181107</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103909</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181107</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TNKase® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI).</IndicationAndUsage>
<Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
</NDC>
<NDC>
<NDCCode>50242-176-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50242-176-01) * 1 VIAL, SINGLE-USE in 1 CARTON (50242-037-06) / 10 mL in 1 VIAL, SINGLE-USE * 1 VIAL, SINGLE-USE in 1 CARTON (50242-901-09) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0176-01</NDC11Code>
<ProductNDC>50242-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tnkase</ProprietaryName>
<NonProprietaryName>Tenecteplase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240105</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103909</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TNKase is a tissue plasminogen activator (tPA) indicated: 1 for the treatment of acute ischemic stroke (AIS) in adults. (1.1), 2 to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. (1.2).</IndicationAndUsage>
<Description>Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each 25 mg single-dose vial of TNKase nominally contains 25 mg of tenecteplase, arginine (261 mg), phosphoric acid (approximately 80 mg), and polysorbate 20 (2.0 mg). Following reconstitution with the supplied 5.2 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3. Each 50 mg single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3.</Description>
</NDC>
<NDC>
<NDCCode>50268-527-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-527-15) / 1 TABLET in 1 BLISTER PACK (50268-527-11) </PackageDescription>
<NDC11Code>50268-0527-15</NDC11Code>
<ProductNDC>50268-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methotrexate</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210040</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: : 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1) , 2 Treatment of adults with mycosis fungoides. ( 1.1) , 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen. ( 1.1) , 4 Treatment of adults with rheumatoid arthritis. ( 1.2) , 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). ( 1.3) , 6 Treatment of adults with severe psoriasis. ( 1.4) .</IndicationAndUsage>
<Description>Methotrexate, USP is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C 20H 22N 8O 5 and the molecular weight is 454.4 g/mol. The structural formula is:. Methotrexate tablets, USP for oral use are available in bottles of 36 and 100 tablets. Each methotrexate tablet, USP contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: lactose monohydrate, magnesium stearate and maize starch.</Description>
</NDC>
<NDC>
<NDCCode>55801-527-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (55801-527-01) </PackageDescription>
<NDC11Code>55801-0527-01</NDC11Code>
<ProductNDC>55801-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214908</ApplicationNumber>
<LabelerName>Appco Pharma LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are recommended for the treatment of. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO HCl having a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and in methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3- dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin hydrochloride capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 25 mg, 50 mg, 75 mg, 100 mg empty gelatin capsule shells contain D&C Yellow No. 10. The 25 mg, 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6. The 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The 10 mg empty gelatin capsule shells contain Iron Oxide Yellow. The imprint ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>55801-527-02</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (55801-527-02) </PackageDescription>
<NDC11Code>55801-0527-02</NDC11Code>
<ProductNDC>55801-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214908</ApplicationNumber>
<LabelerName>Appco Pharma LLC</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are recommended for the treatment of. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO HCl having a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and in methylene chloride. It may be represented by the following structural formula. Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3- dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin hydrochloride capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 25 mg, 50 mg, 75 mg, 100 mg empty gelatin capsule shells contain D&C Yellow No. 10. The 25 mg, 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6. The 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The 10 mg empty gelatin capsule shells contain Iron Oxide Yellow. The imprint ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>61269-527-98</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (61269-527-98) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>61269-0527-98</NDC11Code>
<ProductNDC>61269-527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Allergy</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220718</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203330</ApplicationNumber>
<LabelerName>H2-Pharma, LLC</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220718</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
</NDCList>