{
"NDC": [
{
"NDCCode": "50383-357-31",
"PackageDescription": "4 TRAY in 1 CASE (50383-357-31) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (50383-357-30) ",
"NDC11Code": "50383-0357-31",
"ProductNDC": "50383-357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19950703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074076",
"LabelerName": "Akorn",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221221",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "50383-779-31",
"PackageDescription": "4 TRAY in 1 CASE (50383-779-31) > 10 CUP in 1 TRAY (50383-779-30) > 30 mL in 1 CUP",
"NDC11Code": "50383-0779-31",
"ProductNDC": "50383-779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19950703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074076",
"LabelerName": "Akorn",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20090904",
"SamplePackage": "N"
},
{
"NDCCode": "50383-357-33",
"PackageDescription": "10 TRAY in 1 CASE (50383-357-33) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (50383-357-30) ",
"NDC11Code": "50383-0357-33",
"ProductNDC": "50383-357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19950703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074076",
"LabelerName": "Akorn",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221221",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "55315-357-31",
"PackageDescription": "2 BOTTLE in 1 CARTON (55315-357-31) > 355 mL in 1 BOTTLE",
"NDC11Code": "55315-0357-31",
"ProductNDC": "55315-357",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Nighttime Relief",
"NonProprietaryName": "Acetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150824",
"EndMarketingDate": "20211001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Fred's, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2021-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150824",
"EndMarketingDatePackage": "20211001",
"SamplePackage": "N"
},
{
"NDCCode": "50383-241-16",
"PackageDescription": "473 mL in 1 BOTTLE (50383-241-16) ",
"NDC11Code": "50383-0241-16",
"ProductNDC": "50383-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20120228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090601",
"LabelerName": "Akorn",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120228",
"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), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam Oral Solution is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, 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 is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, ammonium glycyrrhizinate, citric acid anhydrous, glycerin, maltitol solution, methylparaben, propylparaben, purified water, sodium citrate dihydrate and natural and artificial grape flavor."
},
{
"NDCCode": "50383-356-17",
"PackageDescription": "4 TRAY in 1 CASE (50383-356-17) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (50383-356-15) ",
"NDC11Code": "50383-0356-17",
"ProductNDC": "50383-356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19950703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074076",
"LabelerName": "Akorn",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221221",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "50383-363-17",
"PackageDescription": "4 TRAY in 1 CASE (50383-363-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (50383-363-15) ",
"NDC11Code": "50383-0363-17",
"ProductNDC": "50383-363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "19950710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040014",
"LabelerName": "Akorn",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221221",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.",
"Description": "Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34."
},
{
"NDCCode": "50383-705-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-705-30) / 30 mL in 1 BOTTLE",
"NDC11Code": "50383-0705-30",
"ProductNDC": "50383-705",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200169",
"LabelerName": "Akorn",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Each mL of Lorazepam for oral administration contains. Lorazepam........................................................ 2 mg. Inactive Ingredients. Lorazepam contains polyethylene glycol and propylene glycol. Lorazepam, an antianxiety agent, has the chemical formula, 2H-1,4-benzodiazepin-2-one, 7- chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-. Lorazepam is a nearly white powder almost insoluble in water."
},
{
"NDCCode": "50383-775-04",
"PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (50383-775-04) ",
"NDC11Code": "50383-0775-04",
"ProductNDC": "50383-775",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "19950710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040014",
"LabelerName": "Akorn",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19950710",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.",
"Description": "Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34."
},
{
"NDCCode": "50383-775-17",
"PackageDescription": "4 TRAY in 1 CASE (50383-775-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (50383-775-15) ",
"NDC11Code": "50383-0775-17",
"ProductNDC": "50383-775",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "19950710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040014",
"LabelerName": "Akorn",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150324",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.",
"Description": "Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34."
},
{
"NDCCode": "50383-779-16",
"PackageDescription": "473 mL in 1 BOTTLE (50383-779-16) ",
"NDC11Code": "50383-0779-16",
"ProductNDC": "50383-779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19950703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074076",
"LabelerName": "Akorn",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19950703",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "50383-779-32",
"PackageDescription": "946 mL in 1 BOTTLE (50383-779-32) ",
"NDC11Code": "50383-0779-32",
"ProductNDC": "50383-779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19950703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074076",
"LabelerName": "Akorn",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19950703",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "50383-779-33",
"PackageDescription": "10 TRAY in 1 CASE (50383-779-33) / 10 CUP in 1 TRAY / 30 mL in 1 CUP",
"NDC11Code": "50383-0779-33",
"ProductNDC": "50383-779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19950703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074076",
"LabelerName": "Akorn",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090904",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "50383-804-16",
"PackageDescription": "473 mL in 1 BOTTLE (50383-804-16) ",
"NDC11Code": "50383-0804-16",
"ProductNDC": "50383-804",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
"NonProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19970826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040151",
"LabelerName": "Akorn",
"SubstanceName": "CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19970826",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine HCl and codeine phosphate oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.",
"Description": "Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine. Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution contains 10 mg of codeine phosphate and 6.25 mg of promethazine hydrochloride for oral administration. Promethazine HCl and Codeine Phosphate Oral Solution has a pH between 4.3 and 5.3 and contains alcohol 7%. Promethazine HCl and Codeine Phosphate Oral Solution also contains the following inactive ingredients: Artificial boysenberry flavor, ascorbic acid, citric acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Yellow No. 6, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose syrup. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4 ½ H2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure."
},
{
"NDCCode": "50383-805-04",
"PackageDescription": "118 mL in 1 BOTTLE (50383-805-04) ",
"NDC11Code": "50383-0805-04",
"ProductNDC": "50383-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate",
"NonProprietaryName": "Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040674",
"LabelerName": "Akorn",
"SubstanceName": "CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "10; 5; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160606",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve promethazine HCl, phenylephrine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.",
"Description": "Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP contains codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. Each 5 mL of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP contains 10 mg of codeine phosphate, 6.25 mg of promethazine hydrochloride, and 5 mg of phenylephrine hydrochloride for oral administration. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP has a pH between 3.8 and 4.6 and contains alcohol 7%. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP also contains the following inactive ingredients: Ascorbic acid, citric acid, FD&C Yellow #6, methylparaben, natural tangerine extract, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucrose syrup. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4 ½ H2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure. Phenylephrine Hydrochloride. The chemical name for phenylephrine hydrochloride, a sympathomimetic amine salt, is (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. The molecular weight is 203.67. Its molecular formula is C9H13NO2 HCl, and it has the following chemical structure."
},
{
"NDCCode": "50383-805-16",
"PackageDescription": "473 mL in 1 BOTTLE (50383-805-16) ",
"NDC11Code": "50383-0805-16",
"ProductNDC": "50383-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate",
"NonProprietaryName": "Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040674",
"LabelerName": "Akorn",
"SubstanceName": "CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "10; 5; 6.25",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160606",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve promethazine HCl, phenylephrine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.",
"Description": "Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP contains codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. Each 5 mL of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP contains 10 mg of codeine phosphate, 6.25 mg of promethazine hydrochloride, and 5 mg of phenylephrine hydrochloride for oral administration. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP has a pH between 3.8 and 4.6 and contains alcohol 7%. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP also contains the following inactive ingredients: Ascorbic acid, citric acid, FD&C Yellow #6, methylparaben, natural tangerine extract, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucrose syrup. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4 ½ H2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure. Phenylephrine Hydrochloride. The chemical name for phenylephrine hydrochloride, a sympathomimetic amine salt, is (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. The molecular weight is 203.67. Its molecular formula is C9H13NO2 HCl, and it has the following chemical structure."
},
{
"NDCCode": "50383-912-03",
"PackageDescription": "1 BOTTLE in 1 KIT (50383-912-03) > 3 mL in 1 BOTTLE",
"NDC11Code": "50383-0912-03",
"ProductNDC": "50383-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203051",
"LabelerName": "Akorn",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": "3",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180926",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.",
"Description": "Bimatoprost ophthalmic solution 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2- [(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5- heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride NF 0.05 mg/mL; Inactives: citric acid USP; purified water USP; sodium chloride USP; and sodium phosphate USP, dibasic. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH during its shelf life ranges from 6.8 - 7.8."
},
{
"NDCCode": "50383-912-05",
"PackageDescription": "1 BOTTLE in 1 KIT (50383-912-05) > 5 mL in 1 BOTTLE",
"NDC11Code": "50383-0912-05",
"ProductNDC": "50383-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203051",
"LabelerName": "Akorn",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": "3",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210215",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.",
"Description": "Bimatoprost ophthalmic solution 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2- [(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5- heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride NF 0.05 mg/mL; Inactives: citric acid USP; purified water USP; sodium chloride USP; and sodium phosphate USP, dibasic. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH during its shelf life ranges from 6.8 - 7.8."
},
{
"NDCCode": "50383-933-35",
"PackageDescription": "1 TUBE in 1 CARTON (50383-933-35) > 35.44 g in 1 TUBE",
"NDC11Code": "50383-0933-35",
"ProductNDC": "50383-933",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120312",
"EndMarketingDate": "20211230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040911",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120312",
"EndMarketingDatePackage": "20211230",
"SamplePackage": "N"
},
{
"NDCCode": "50383-933-55",
"PackageDescription": "50 g in 1 JAR (50383-933-55) ",
"NDC11Code": "50383-0933-55",
"ProductNDC": "50383-933",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120312",
"EndMarketingDate": "20211230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040911",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120312",
"EndMarketingDatePackage": "20211230",
"SamplePackage": "N"
},
{
"NDCCode": "50383-943-23",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-943-23) > 240 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "50383-0943-23",
"ProductNDC": "50383-943",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olopatadine Hydrochloride",
"NonProprietaryName": "Olopatadine Hydrochloride Nasal",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20200929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213757",
"LabelerName": "Akorn",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "665",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200929",
"SamplePackage": "N",
"IndicationAndUsage": "Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.",
"Description": "Olopatadine Hydrochloride Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Spray, is a white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz [b,e]oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3 HCl with the following chemical structure. Olopatadine Hydrochloride Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [see Dosage Forms and Strengths (3)]. Olopatadine Hydrochloride Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water."
},
{
"NDCCode": "31722-051-31",
"PackageDescription": "30 SUPPOSITORY in 1 CARTON (31722-051-31) ",
"NDC11Code": "31722-0051-31",
"ProductNDC": "31722-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20250703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216905",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250703",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin Suppository is indicated for. Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis.",
"Description": "Indomethacin Suppositories USP is a nonsteroidal anti-inflammatory drug, available as a suppository containing 50 mg of indomethacin administered for rectal use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is sparingly soluble in absolute alcohol, chloroform and ether and insoluble in water. It has a pKa of 4.7. The inactive ingredients in indomethacin suppositories include: Butylated hydroxy anisole, butylated hydroxy toluene, edetic acid, glycerin, polyethylene glycol 3350, polyethylene glycol 8000 and sodium chloride. Indomethacin suppositories, 50 mg each, are white to off-white, bullet shaped, rectal suppositories. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "51655-357-26",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-357-26) ",
"NDC11Code": "51655-0357-26",
"ProductNDC": "51655-357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202304",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200528",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)] . The efficacy of bupropion hydrochloride extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)] .",
"Description": "Bupropion hydrochloride extended-release tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO ∙HCl. Bupropion hydrochloride, USP powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) is supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 2 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red and Ferrosoferric Oxide. Meet USP Dissolution Test 7."
},
{
"NDCCode": "51655-357-52",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-357-52) ",
"NDC11Code": "51655-0357-52",
"ProductNDC": "51655-357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202304",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220901",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)] . The efficacy of bupropion hydrochloride extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)] .",
"Description": "Bupropion hydrochloride extended-release tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO ∙HCl. Bupropion hydrochloride, USP powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) is supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 2 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red and Ferrosoferric Oxide. Meet USP Dissolution Test 7."
},
{
"NDCCode": "60687-516-21",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (60687-516-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-516-11) ",
"NDC11Code": "60687-0516-21",
"ProductNDC": "60687-516",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209226",
"LabelerName": "American Health Packaging",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250610",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1) Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis , 2 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2) , 3 Severe hypercalcemia in adult patients with primary HPT who are unable to parathyroidectomy. ( 1.3) .",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C 22H 22F 3N·HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol and dimethylformamide. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1- naphthyl)ethyl]-3- [3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula:. Cinacalcet tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet equivalent (33 mg, 66 mg, and 99 mg as cincalcet hydrochloride salt, respectively). Inactive Ingredients The following are the inactive ingredients in cinacalcet tablets: pre-gelatinized starch, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypermellose, polyethylene glycols, lactose monohydrate, titanium dioxide, triacetin, ferric oxide yellow, FD&C blue #2 and carnauba wax."
},
{
"NDCCode": "63629-8765-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63629-8765-1) ",
"NDC11Code": "63629-8765-01",
"ProductNDC": "63629-8765",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210570",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190518",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. : 1 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 2 Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, powder that is soluble in methanol, 95% ethanol and slightly soluble in water. Cinacalcet tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating."
},
{
"NDCCode": "50383-001-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-001-02) > 60 mL in 1 BOTTLE",
"NDC11Code": "50383-0001-02",
"ProductNDC": "50383-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074731",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19961224",
"SamplePackage": "N"
},
{
"NDCCode": "50383-001-20",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-001-20) > 60 mL in 1 BOTTLE",
"NDC11Code": "50383-0001-20",
"ProductNDC": "50383-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minoxidil",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19961224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074731",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19961224",
"SamplePackage": "N"
},
{
"NDCCode": "50383-010-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-010-15) > 15 mL in 1 BOTTLE",
"NDC11Code": "50383-0010-15",
"ProductNDC": "50383-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Redness Reliever",
"NonProprietaryName": "Redness Reliever",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19960617",
"EndMarketingDate": "20140420",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "50383-018-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (50383-018-04) > 118 mL in 1 BOTTLE",
"NDC11Code": "50383-0018-04",
"ProductNDC": "50383-018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Wash",
"NonProprietaryName": "Eye Wash",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "INTRAOCULAR",
"StartMarketingDate": "19970106",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Hi-Tech Pharmacal Co., Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "980",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19970107",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50383-357-31</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-357-31) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (50383-357-30) </PackageDescription>
<NDC11Code>50383-0357-31</NDC11Code>
<ProductNDC>50383-357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074076</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>50383-779-31</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-779-31) > 10 CUP in 1 TRAY (50383-779-30) > 30 mL in 1 CUP</PackageDescription>
<NDC11Code>50383-0779-31</NDC11Code>
<ProductNDC>50383-779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074076</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-357-33</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (50383-357-33) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (50383-357-30) </PackageDescription>
<NDC11Code>50383-0357-33</NDC11Code>
<ProductNDC>50383-357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074076</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>55315-357-31</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (55315-357-31) > 355 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55315-0357-31</NDC11Code>
<ProductNDC>55315-357</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Nighttime Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Doxylamine Succinate, And Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150824</StartMarketingDate>
<EndMarketingDate>20211001</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Fred's, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150824</StartMarketingDatePackage>
<EndMarketingDatePackage>20211001</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-241-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (50383-241-16) </PackageDescription>
<NDC11Code>50383-0241-16</NDC11Code>
<ProductNDC>50383-241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090601</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam Oral Solution is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, 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 is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, ammonium glycyrrhizinate, citric acid anhydrous, glycerin, maltitol solution, methylparaben, propylparaben, purified water, sodium citrate dihydrate and natural and artificial grape flavor.</Description>
</NDC>
<NDC>
<NDCCode>50383-356-17</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-356-17) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (50383-356-15) </PackageDescription>
<NDC11Code>50383-0356-17</NDC11Code>
<ProductNDC>50383-356</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074076</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>50383-363-17</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-363-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (50383-363-15) </PackageDescription>
<NDC11Code>50383-0363-17</NDC11Code>
<ProductNDC>50383-363</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>19950710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040014</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34.</Description>
</NDC>
<NDC>
<NDCCode>50383-705-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-705-30) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0705-30</NDC11Code>
<ProductNDC>50383-705</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200169</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Each mL of Lorazepam for oral administration contains. Lorazepam........................................................ 2 mg. Inactive Ingredients. Lorazepam contains polyethylene glycol and propylene glycol. Lorazepam, an antianxiety agent, has the chemical formula, 2H-1,4-benzodiazepin-2-one, 7- chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-. Lorazepam is a nearly white powder almost insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>50383-775-04</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, PLASTIC (50383-775-04) </PackageDescription>
<NDC11Code>50383-0775-04</NDC11Code>
<ProductNDC>50383-775</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>19950710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040014</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34.</Description>
</NDC>
<NDC>
<NDCCode>50383-775-17</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (50383-775-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (50383-775-15) </PackageDescription>
<NDC11Code>50383-0775-17</NDC11Code>
<ProductNDC>50383-775</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>19950710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040014</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34.</Description>
</NDC>
<NDC>
<NDCCode>50383-779-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (50383-779-16) </PackageDescription>
<NDC11Code>50383-0779-16</NDC11Code>
<ProductNDC>50383-779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074076</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>50383-779-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE (50383-779-32) </PackageDescription>
<NDC11Code>50383-0779-32</NDC11Code>
<ProductNDC>50383-779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074076</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>50383-779-33</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (50383-779-33) / 10 CUP in 1 TRAY / 30 mL in 1 CUP</PackageDescription>
<NDC11Code>50383-0779-33</NDC11Code>
<ProductNDC>50383-779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074076</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 4.8 to 6.0. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C12H22O11. It has the following structural formula. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>50383-804-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (50383-804-16) </PackageDescription>
<NDC11Code>50383-0804-16</NDC11Code>
<ProductNDC>50383-804</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040151</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine HCl and codeine phosphate oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
<Description>Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine. Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution contains 10 mg of codeine phosphate and 6.25 mg of promethazine hydrochloride for oral administration. Promethazine HCl and Codeine Phosphate Oral Solution has a pH between 4.3 and 5.3 and contains alcohol 7%. Promethazine HCl and Codeine Phosphate Oral Solution also contains the following inactive ingredients: Artificial boysenberry flavor, ascorbic acid, citric acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Yellow No. 6, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose syrup. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4 ½ H2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>50383-805-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (50383-805-04) </PackageDescription>
<NDC11Code>50383-0805-04</NDC11Code>
<ProductNDC>50383-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040674</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 5; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve promethazine HCl, phenylephrine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
<Description>Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP contains codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. Each 5 mL of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP contains 10 mg of codeine phosphate, 6.25 mg of promethazine hydrochloride, and 5 mg of phenylephrine hydrochloride for oral administration. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP has a pH between 3.8 and 4.6 and contains alcohol 7%. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP also contains the following inactive ingredients: Ascorbic acid, citric acid, FD&C Yellow #6, methylparaben, natural tangerine extract, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucrose syrup. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4 ½ H2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure. Phenylephrine Hydrochloride. The chemical name for phenylephrine hydrochloride, a sympathomimetic amine salt, is (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. The molecular weight is 203.67. Its molecular formula is C9H13NO2 HCl, and it has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>50383-805-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (50383-805-16) </PackageDescription>
<NDC11Code>50383-0805-16</NDC11Code>
<ProductNDC>50383-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride, Phenylephrine Hydrochloride And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040674</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 5; 6.25</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine HCl, phenylephrine HCl and codeine phosphate oral solution, USP is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve promethazine HCl, phenylephrine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
<Description>Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP contains codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. Each 5 mL of Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP contains 10 mg of codeine phosphate, 6.25 mg of promethazine hydrochloride, and 5 mg of phenylephrine hydrochloride for oral administration. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP has a pH between 3.8 and 4.6 and contains alcohol 7%. Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution, USP also contains the following inactive ingredients: Ascorbic acid, citric acid, FD&C Yellow #6, methylparaben, natural tangerine extract, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucrose syrup. Codeine Phosphate. The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4 ½ H2O, and it has the following chemical structure. Promethazine Hydrochloride. The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure. Phenylephrine Hydrochloride. The chemical name for phenylephrine hydrochloride, a sympathomimetic amine salt, is (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. The molecular weight is 203.67. Its molecular formula is C9H13NO2 HCl, and it has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>50383-912-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (50383-912-03) > 3 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0912-03</NDC11Code>
<ProductNDC>50383-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203051</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2- [(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5- heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride NF 0.05 mg/mL; Inactives: citric acid USP; purified water USP; sodium chloride USP; and sodium phosphate USP, dibasic. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH during its shelf life ranges from 6.8 - 7.8.</Description>
</NDC>
<NDC>
<NDCCode>50383-912-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (50383-912-05) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0912-05</NDC11Code>
<ProductNDC>50383-912</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203051</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2- [(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5- heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride NF 0.05 mg/mL; Inactives: citric acid USP; purified water USP; sodium chloride USP; and sodium phosphate USP, dibasic. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH during its shelf life ranges from 6.8 - 7.8.</Description>
</NDC>
<NDC>
<NDCCode>50383-933-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50383-933-35) > 35.44 g in 1 TUBE</PackageDescription>
<NDC11Code>50383-0933-35</NDC11Code>
<ProductNDC>50383-933</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120312</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040911</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120312</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-933-55</NDCCode>
<PackageDescription>50 g in 1 JAR (50383-933-55) </PackageDescription>
<NDC11Code>50383-0933-55</NDC11Code>
<ProductNDC>50383-933</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120312</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040911</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120312</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-943-23</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-943-23) > 240 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0943-23</NDC11Code>
<ProductNDC>50383-943</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olopatadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride Nasal</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20200929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213757</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>665</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.</IndicationAndUsage>
<Description>Olopatadine Hydrochloride Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Spray, is a white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz [b,e]oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3 HCl with the following chemical structure. Olopatadine Hydrochloride Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [see Dosage Forms and Strengths (3)]. Olopatadine Hydrochloride Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.</Description>
</NDC>
<NDC>
<NDCCode>31722-051-31</NDCCode>
<PackageDescription>30 SUPPOSITORY in 1 CARTON (31722-051-31) </PackageDescription>
<NDC11Code>31722-0051-31</NDC11Code>
<ProductNDC>31722-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20250703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216905</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin Suppository is indicated for. Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Suppositories USP is a nonsteroidal anti-inflammatory drug, available as a suppository containing 50 mg of indomethacin administered for rectal use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is sparingly soluble in absolute alcohol, chloroform and ether and insoluble in water. It has a pKa of 4.7. The inactive ingredients in indomethacin suppositories include: Butylated hydroxy anisole, butylated hydroxy toluene, edetic acid, glycerin, polyethylene glycol 3350, polyethylene glycol 8000 and sodium chloride. Indomethacin suppositories, 50 mg each, are white to off-white, bullet shaped, rectal suppositories. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>51655-357-26</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-357-26) </PackageDescription>
<NDC11Code>51655-0357-26</NDC11Code>
<ProductNDC>51655-357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202304</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)] . The efficacy of bupropion hydrochloride extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO ∙HCl. Bupropion hydrochloride, USP powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) is supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 2 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red and Ferrosoferric Oxide. Meet USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>51655-357-52</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-357-52) </PackageDescription>
<NDC11Code>51655-0357-52</NDC11Code>
<ProductNDC>51655-357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202304</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)] . The efficacy of bupropion hydrochloride extended-release (SR) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO ∙HCl. Bupropion hydrochloride, USP powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets USP (SR) is supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 2 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red and Ferrosoferric Oxide. Meet USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>60687-516-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (60687-516-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-516-11) </PackageDescription>
<NDC11Code>60687-0516-21</NDC11Code>
<ProductNDC>60687-516</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209226</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1) Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis , 2 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2) , 3 Severe hypercalcemia in adult patients with primary HPT who are unable to parathyroidectomy. ( 1.3) .</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C 22H 22F 3N·HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol and dimethylformamide. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1- naphthyl)ethyl]-3- [3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula:. Cinacalcet tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet equivalent (33 mg, 66 mg, and 99 mg as cincalcet hydrochloride salt, respectively). Inactive Ingredients The following are the inactive ingredients in cinacalcet tablets: pre-gelatinized starch, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypermellose, polyethylene glycols, lactose monohydrate, titanium dioxide, triacetin, ferric oxide yellow, FD&C blue #2 and carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>63629-8765-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63629-8765-1) </PackageDescription>
<NDC11Code>63629-8765-01</NDC11Code>
<ProductNDC>63629-8765</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210570</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. : 1 Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2), 2 Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, powder that is soluble in methanol, 95% ethanol and slightly soluble in water. Cinacalcet tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula. Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: Lactose monohydrate, microcrystalline cellulose (GR 101 and GR 102), crospovidone, hydroxypropyl cellulose, magnesium stearate. In addition polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, FD&C blue #2/Indigo carmine AL are included in the film coating.</Description>
</NDC>
<NDC>
<NDCCode>50383-001-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-001-02) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0001-02</NDC11Code>
<ProductNDC>50383-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074731</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-001-20</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-001-20) > 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0001-20</NDC11Code>
<ProductNDC>50383-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minoxidil</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19961224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074731</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50383-010-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-010-15) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0010-15</NDC11Code>
<ProductNDC>50383-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Redness Reliever</ProprietaryName>
<NonProprietaryName>Redness Reliever</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19960617</StartMarketingDate>
<EndMarketingDate>20140420</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>50383-018-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50383-018-04) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50383-0018-04</NDC11Code>
<ProductNDC>50383-018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eye Wash</ProprietaryName>
<NonProprietaryName>Eye Wash</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>INTRAOCULAR</RouteName>
<StartMarketingDate>19970106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Hi-Tech Pharmacal Co., Inc.</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>980</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>