{
"NDC": [
{
"NDCCode": "62980-964-07",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (62980-964-07)",
"NDC11Code": "62980-0964-07",
"ProductNDC": "62980-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "42543-964-07",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42543-964-07) ",
"NDC11Code": "42543-0964-07",
"ProductNDC": "42543-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078329",
"LabelerName": "Strides Pharma Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200821",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide."
},
{
"NDCCode": "55648-964-07",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55648-964-07)",
"NDC11Code": "55648-0964-07",
"ProductNDC": "55648-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "WOCKHARDT LIMITED",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64679-964-07",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64679-964-07) ",
"NDC11Code": "64679-0964-07",
"ProductNDC": "64679-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150728",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1) , 2 Acute bacterial sinusitis in adults ( 1.1) , 3 Uncomplicated skin and skin structure infections in adults ( 1.1) , 4 Urethritis and cervicitis in adults ( 1.1) , 5 Genital ulcer disease in men ( 1.1) , 6 Acute otitis media in pediatric patients (6 months of age and older) ( 1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1, 1.2) .",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749. Azithromycin has the following structural formula:. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C 38H 72N 2O 12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, magnesium trisilicate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "62980-964-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (62980-964-01)",
"NDC11Code": "62980-0964-01",
"ProductNDC": "62980-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "62980-964-02",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (62980-964-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK (62980-964-09)",
"NDC11Code": "62980-0964-02",
"ProductNDC": "62980-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "62980-964-05",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (62980-964-05) > 3 TABLET, FILM COATED in 1 BLISTER PACK (62980-964-03)",
"NDC11Code": "62980-0964-05",
"ProductNDC": "62980-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "62980-964-08",
"PackageDescription": "1700 TABLET, FILM COATED in 1 BAG (62980-964-08)",
"NDC11Code": "62980-0964-08",
"ProductNDC": "62980-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "62980-121-06",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (62980-121-06) > 24 TABLET in 1 BLISTER PACK (62980-121-07)",
"NDC11Code": "62980-0121-06",
"ProductNDC": "62980-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090073",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "62980-122-06",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (62980-122-06) > 24 TABLET in 1 BLISTER PACK (62980-122-07)",
"NDC11Code": "62980-0122-06",
"ProductNDC": "62980-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090073",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "62980-907-07",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (62980-907-07) ",
"NDC11Code": "62980-0907-07",
"ProductNDC": "62980-907",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hyrochloride",
"ProprietaryNameSuffix": "5mg",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090551",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191105",
"SamplePackage": "N"
},
{
"NDCCode": "62980-908-07",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (62980-908-07) ",
"NDC11Code": "62980-0908-07",
"ProductNDC": "62980-908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hyrochloride",
"ProprietaryNameSuffix": "5mg",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090551",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191105",
"SamplePackage": "N"
},
{
"NDCCode": "62980-961-07",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (62980-961-07)",
"NDC11Code": "62980-0961-07",
"ProductNDC": "62980-961",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065404",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .",
"Description": "Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "37808-964-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (37808-964-91)",
"NDC11Code": "37808-0964-91",
"ProductNDC": "37808-964",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rx Act Flu And Severe Cold And Cough",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100922",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "H E B",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "41163-964-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (41163-964-91) ",
"NDC11Code": "41163-0964-91",
"ProductNDC": "41163-964",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Flu And Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110726",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "United Natural Foods, Inc. dba UNFI",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110726",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. runny nose. sneezing. itchy nose or throat. itchy, watery eyes due to hay fever. cough due to minor throat and bronchial irritation. temporarily reduces fever."
},
{
"NDCCode": "43269-964-08",
"PackageDescription": "436 mL in 1 BOTTLE, DISPENSING (43269-964-08) ",
"NDC11Code": "43269-0964-08",
"ProductNDC": "43269-964",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200605",
"EndMarketingDate": "20220605",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200605",
"EndMarketingDatePackage": "20220605",
"SamplePackage": "N"
},
{
"NDCCode": "49738-964-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (49738-964-91)",
"NDC11Code": "49738-0964-91",
"ProductNDC": "49738-964",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Sense Flu And Severe Cold And Cough",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kmart Corporation",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "55312-964-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (55312-964-91)",
"NDC11Code": "55312-0964-91",
"ProductNDC": "55312-964",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu And Severe Cold And Cough",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100923",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Western Family Foods Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "56062-964-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (56062-964-91) ",
"NDC11Code": "56062-0964-91",
"ProductNDC": "56062-964",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu And Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110929",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Publix Super Markets Inc",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110929",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. runny nose. sneezing. itchy nose or throat. itchy, watery eyes due to hay fever. cough due to minor throat and bronchial irritation. temporarily reduces fever."
},
{
"NDCCode": "58443-0522-7",
"PackageDescription": "964 mL in 1 BOTTLE (58443-0522-7) ",
"NDC11Code": "58443-0522-07",
"ProductNDC": "58443-0522",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shamrock Sun",
"ProprietaryNameSuffix": "Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191212",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Enterprises, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "29.04; 96.8; 48.4; 48.4",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191212",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "59779-964-51",
"PackageDescription": "8 POWDER, FOR SOLUTION in 1 CARTON (59779-964-51)",
"NDC11Code": "59779-0964-51",
"ProductNDC": "59779-964",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu And Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100914",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "59779-964-91",
"PackageDescription": "6 POWDER, FOR SOLUTION in 1 CARTON (59779-964-91)",
"NDC11Code": "59779-0964-91",
"ProductNDC": "59779-964",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu And Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100914",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "61755-964-00",
"PackageDescription": "1000 mL in 1 BOTTLE (61755-964-00) ",
"NDC11Code": "61755-0964-00",
"ProductNDC": "61755-964",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Maftivimab",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "MAFTIVIMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-07-18",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-JUL-21"
},
{
"NDCCode": "61755-964-01",
"PackageDescription": "5000 mL in 1 BOTTLE (61755-964-01) ",
"NDC11Code": "61755-0964-01",
"ProductNDC": "61755-964",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Maftivimab",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "MAFTIVIMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2024-07-18",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-JUL-21"
},
{
"NDCCode": "63187-964-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-30) ",
"NDC11Code": "63187-0964-30",
"ProductNDC": "63187-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078279",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 1.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 2.Risk reduction of NSAID-associated gastric ulcer (1.2) , 3 3. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .",
"Description": "The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "63187-964-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-60) ",
"NDC11Code": "63187-0964-60",
"ProductNDC": "63187-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078279",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 1.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 2.Risk reduction of NSAID-associated gastric ulcer (1.2) , 3 3. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .",
"Description": "The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "63187-964-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-90) ",
"NDC11Code": "63187-0964-90",
"ProductNDC": "63187-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078279",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 1.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 2.Risk reduction of NSAID-associated gastric ulcer (1.2) , 3 3. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .",
"Description": "The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac."
},
{
"NDCCode": "64679-964-06",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (64679-964-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64679-0964-06",
"ProductNDC": "64679-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065405",
"LabelerName": "WOCKHARDT USA LLC.",
"SubstanceName": "AZITHROMYCIN ANHYDROUS",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
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},
{
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"PackageDescription": "6 PACKET in 1 CARTON (72288-964-91) / 1 POWDER, FOR SOLUTION in 1 PACKET",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. runny nose. sneezing. itchy nose or throat. itchy, watery eyes due to hay fever. cough due to minor throat and bronchial irritation. temporarily reduces fever."
},
{
"NDCCode": "62980-117-11",
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"NDC11Code": "62980-0117-11",
"ProductNDC": "62980-117",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Padimate O",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "PADIMATE O",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Vivimed Labs Limited</LabelerName>
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<StrengthNumber>500</StrengthNumber>
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<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol.</Description>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42543-964-07) </PackageDescription>
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<ProductNDC>42543-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
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<Status>Deprecated</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide.</Description>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55648-964-07)</PackageDescription>
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<ProductNDC>55648-964</ProductNDC>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>WOCKHARDT LIMITED</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<ProductNDC>64679-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065405</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>AZITHROMYCIN ANHYDROUS</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1) , 2 Acute bacterial sinusitis in adults ( 1.1) , 3 Uncomplicated skin and skin structure infections in adults ( 1.1) , 4 Urethritis and cervicitis in adults ( 1.1) , 5 Genital ulcer disease in men ( 1.1) , 6 Acute otitis media in pediatric patients (6 months of age and older) ( 1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1, 1.2) .</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749. Azithromycin has the following structural formula:. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C 38H 72N 2O 12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, magnesium trisilicate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.</Description>
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<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62980-964-01)</PackageDescription>
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<ProductNDC>62980-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065405</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>AZITHROMYCIN ANHYDROUS</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
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<PackageDescription>10 BLISTER PACK in 1 CARTON (62980-964-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK (62980-964-09)</PackageDescription>
<NDC11Code>62980-0964-02</NDC11Code>
<ProductNDC>62980-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065405</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>AZITHROMYCIN ANHYDROUS</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (62980-964-05) > 3 TABLET, FILM COATED in 1 BLISTER PACK (62980-964-03)</PackageDescription>
<NDC11Code>62980-0964-05</NDC11Code>
<ProductNDC>62980-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065405</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>AZITHROMYCIN ANHYDROUS</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol.</Description>
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<NDC>
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<PackageDescription>1700 TABLET, FILM COATED in 1 BAG (62980-964-08)</PackageDescription>
<NDC11Code>62980-0964-08</NDC11Code>
<ProductNDC>62980-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065405</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>AZITHROMYCIN ANHYDROUS</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
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<NDCCode>62980-121-06</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (62980-121-06) > 24 TABLET in 1 BLISTER PACK (62980-121-07)</PackageDescription>
<NDC11Code>62980-0121-06</NDC11Code>
<ProductNDC>62980-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090073</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>62980-122-06</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (62980-122-06) > 24 TABLET in 1 BLISTER PACK (62980-122-07)</PackageDescription>
<NDC11Code>62980-0122-06</NDC11Code>
<ProductNDC>62980-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090073</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>62980-907-07</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (62980-907-07) </PackageDescription>
<NDC11Code>62980-0907-07</NDC11Code>
<ProductNDC>62980-907</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hyrochloride</ProprietaryName>
<ProprietaryNameSuffix>5mg</ProprietaryNameSuffix>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090551</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62980-908-07</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (62980-908-07) </PackageDescription>
<NDC11Code>62980-0908-07</NDC11Code>
<ProductNDC>62980-908</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hyrochloride</ProprietaryName>
<ProprietaryNameSuffix>5mg</ProprietaryNameSuffix>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090551</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62980-961-07</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (62980-961-07)</PackageDescription>
<NDC11Code>62980-0961-07</NDC11Code>
<ProductNDC>62980-961</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065404</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>AZITHROMYCIN ANHYDROUS</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: : 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1) , 2 Acute bacterial sinusitis in adults (1.1) , 3 Uncomplicated skin and skin structure infections in adults (1.1) , 4 Urethritis and cervicitis in adults (1.1) , 5 Genital ulcer disease in men (1.1) , 6 Acute otitis media in pediatric patients (1.2) , 7 Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2) , 8 Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2) .</IndicationAndUsage>
<Description>Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Anhydrous azithromycin USP is a white amorphous powder with a molecular formula of C38H72N2O12 and a molecular weight of 749. Azithromycin tablet, USP is supplied for oral administration as white, film-coated, oval shaped biconvex tablets containing anhydrous azithromycin 250 mg or 500 mg and the following inactive ingredients: microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium trisilicate, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, sodium lauryl sulfate, hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>37808-964-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (37808-964-91)</PackageDescription>
<NDC11Code>37808-0964-91</NDC11Code>
<ProductNDC>37808-964</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rx Act Flu And Severe Cold And Cough</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100922</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>41163-964-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (41163-964-91) </PackageDescription>
<NDC11Code>41163-0964-91</NDC11Code>
<ProductNDC>41163-964</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Flu And Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110726</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. runny nose. sneezing. itchy nose or throat. itchy, watery eyes due to hay fever. cough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43269-964-08</NDCCode>
<PackageDescription>436 mL in 1 BOTTLE, DISPENSING (43269-964-08) </PackageDescription>
<NDC11Code>43269-0964-08</NDC11Code>
<ProductNDC>43269-964</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200605</StartMarketingDate>
<EndMarketingDate>20220605</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200605</StartMarketingDatePackage>
<EndMarketingDatePackage>20220605</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49738-964-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (49738-964-91)</PackageDescription>
<NDC11Code>49738-0964-91</NDC11Code>
<ProductNDC>49738-964</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Sense Flu And Severe Cold And Cough</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kmart Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>55312-964-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (55312-964-91)</PackageDescription>
<NDC11Code>55312-0964-91</NDC11Code>
<ProductNDC>55312-964</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu And Severe Cold And Cough</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Western Family Foods Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>56062-964-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (56062-964-91) </PackageDescription>
<NDC11Code>56062-0964-91</NDC11Code>
<ProductNDC>56062-964</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu And Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110929</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Publix Super Markets Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. runny nose. sneezing. itchy nose or throat. itchy, watery eyes due to hay fever. cough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58443-0522-7</NDCCode>
<PackageDescription>964 mL in 1 BOTTLE (58443-0522-7) </PackageDescription>
<NDC11Code>58443-0522-07</NDC11Code>
<ProductNDC>58443-0522</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shamrock Sun</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Enterprises, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>29.04; 96.8; 48.4; 48.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59779-964-51</NDCCode>
<PackageDescription>8 POWDER, FOR SOLUTION in 1 CARTON (59779-964-51)</PackageDescription>
<NDC11Code>59779-0964-51</NDC11Code>
<ProductNDC>59779-964</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu And Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>59779-964-91</NDCCode>
<PackageDescription>6 POWDER, FOR SOLUTION in 1 CARTON (59779-964-91)</PackageDescription>
<NDC11Code>59779-0964-91</NDC11Code>
<ProductNDC>59779-964</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu And Severe Cold And Cough</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>61755-964-00</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (61755-964-00) </PackageDescription>
<NDC11Code>61755-0964-00</NDC11Code>
<ProductNDC>61755-964</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Maftivimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MAFTIVIMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-18</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-JUL-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61755-964-01</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE (61755-964-01) </PackageDescription>
<NDC11Code>61755-0964-01</NDC11Code>
<ProductNDC>61755-964</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Maftivimab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MAFTIVIMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-07-18</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-JUL-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>63187-964-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-30) </PackageDescription>
<NDC11Code>63187-0964-30</NDC11Code>
<ProductNDC>63187-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<ApplicationNumber>ANDA078279</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2023-02-07</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 1.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 2.Risk reduction of NSAID-associated gastric ulcer (1.2) , 3 3. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 1.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 2.Risk reduction of NSAID-associated gastric ulcer (1.2) , 3 3. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac.</Description>
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<ProductNDC>63187-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
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<LabelerName>Proficient Rx LP</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2023-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: : 1 1.Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 2.Risk reduction of NSAID-associated gastric ulcer (1.2) , 3 3. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) .</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac.</Description>
</NDC>
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<ProprietaryName>Azithromycin</ProprietaryName>
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<StartMarketingDate>20080211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065405</ApplicationNumber>
<LabelerName>WOCKHARDT USA LLC.</LabelerName>
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<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
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<StartMarketingDate>20210720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Amazon.com Services LLC</LabelerName>
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<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold:. minor aches and pains. minor sore throat pain. headache. nasal and sinus congestion. runny nose. sneezing. itchy nose or throat. itchy, watery eyes due to hay fever. cough due to minor throat and bronchial irritation. temporarily reduces fever.</IndicationAndUsage>
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<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>PADIMATE O</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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