{
"NDC": [
{
"NDCCode": "72319-016-02",
"PackageDescription": "60 TABLET in 1 CONTAINER (72319-016-02) ",
"NDC11Code": "72319-0016-02",
"ProductNDC": "72319-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219464",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .",
"Description": "Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "72319-016-60",
"PackageDescription": "60 BLISTER PACK in 1 CARTON (72319-016-60) / 10 TABLET in 1 BLISTER PACK (72319-016-10) ",
"NDC11Code": "72319-0016-60",
"ProductNDC": "72319-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219464",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .",
"Description": "Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "72319-003-02",
"PackageDescription": "60 TABLET in 1 CONTAINER (72319-003-02) ",
"NDC11Code": "72319-0003-02",
"ProductNDC": "72319-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219464",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .",
"Description": "Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "72319-006-02",
"PackageDescription": "60 TABLET in 1 BOTTLE (72319-006-02) ",
"NDC11Code": "72319-0006-02",
"ProductNDC": "72319-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Selegiline Hydrochloride",
"NonProprietaryName": "Selegiline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074672",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "SELEGILINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "Selegiline Hydrochloride Tablets, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).",
"Description": "Selegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as 1-deprenyl. The chemical name is: (R)-(-)- N,2-dimethyl- N-2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.74. The molecular formula is C 13H 17NHCl. The structural formula is as follows:. Each tablet, for oral administration, contains 5 mg selegiline hydrochloride. Inactive ingredients are corn starch, lactose monohydrate, microcrystalline cellulose, povidone, and stearic acid."
},
{
"NDCCode": "72319-015-02",
"PackageDescription": "60 TABLET in 1 CONTAINER (72319-015-02) ",
"NDC11Code": "72319-0015-02",
"ProductNDC": "72319-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219464",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .",
"Description": "Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "72319-017-02",
"PackageDescription": "60 TABLET in 1 CONTAINER (72319-017-02) ",
"NDC11Code": "72319-0017-02",
"ProductNDC": "72319-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219464",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260807",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .",
"Description": "Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "72319-021-02",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02) ",
"NDC11Code": "72319-0021-02",
"ProductNDC": "72319-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213517",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina. Ranolazine Extended-Release Tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine Extended-Release Tablets is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine Extended-Release Tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, sodium hydroxide and magnesium stearate. Additional inactive ingredients for the 500 mg tablet include polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red; additional inactive ingredients for the 1000 mg tablet include hypromellose, polydextrose, titanium dioxide, talc, maltodextrin, medium chain triglycerides and iron oxide yellow."
},
{
"NDCCode": "72319-022-02",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-022-02) ",
"NDC11Code": "72319-0022-02",
"ProductNDC": "72319-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213517",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina. Ranolazine Extended-Release Tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine Extended-Release Tablets is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine Extended-Release Tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, sodium hydroxide and magnesium stearate. Additional inactive ingredients for the 500 mg tablet include polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red; additional inactive ingredients for the 1000 mg tablet include hypromellose, polydextrose, titanium dioxide, talc, maltodextrin, medium chain triglycerides and iron oxide yellow."
},
{
"NDCCode": "72319-023-02",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (72319-023-02) ",
"NDC11Code": "72319-0023-02",
"ProductNDC": "72319-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Posaconazole",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216488",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230915",
"SamplePackage": "N",
"Description": "Posaconazole is an azole antifungal agent. Posaconazole is available as a delayed-release tablet intended for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with a molecular formula of C 37H 42F 2N 8O 4and a molecular weight of 700.8. The chemical structure is:. Posaconazole is a white to off white powder with a low aqueous solubility. Posaconazole delayed-release tablet is a yellow, oval shaped, film-coated tablet containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose acetate succinate, iron oxide yellow, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol 3350/4000, polyvinyl alcohol, silicon dioxide, talc, and titanium dioxide."
},
{
"NDCCode": "72319-024-02",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72319-024-02) ",
"NDC11Code": "72319-0024-02",
"ProductNDC": "72319-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maraviroc",
"NonProprietaryName": "Maraviroc",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217114",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "MARAVIROC",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230915",
"SamplePackage": "N",
"IndicationAndUsage": "Maraviroc is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use: 1 Maraviroc is not recommended in patients with dual/mixed- or CXCR4-tropic HIV- 1 [see Microbiology (12.4)] . .",
"Description": "Maraviroc is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. Maraviroc film-coated tablets for oral administration contain 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue # 2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5- methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1- phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to off-white powder with a molecular weight of 513.68. It is very soluble in methanol and is highly soluble across the physiological pH range (pH 1.0 to 7.5)."
},
{
"NDCCode": "72319-025-02",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72319-025-02) ",
"NDC11Code": "72319-0025-02",
"ProductNDC": "72319-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maraviroc",
"NonProprietaryName": "Maraviroc",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217114",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "MARAVIROC",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230915",
"SamplePackage": "N",
"IndicationAndUsage": "Maraviroc is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use: 1 Maraviroc is not recommended in patients with dual/mixed- or CXCR4-tropic HIV- 1 [see Microbiology (12.4)] . .",
"Description": "Maraviroc is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. Maraviroc film-coated tablets for oral administration contain 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue # 2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5- methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1- phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to off-white powder with a molecular weight of 513.68. It is very soluble in methanol and is highly soluble across the physiological pH range (pH 1.0 to 7.5)."
},
{
"NDCCode": "72319-030-02",
"PackageDescription": "60 TABLET in 1 BOTTLE (72319-030-02) ",
"NDC11Code": "72319-0030-02",
"ProductNDC": "72319-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methscopolamine Bromide",
"NonProprietaryName": "Methscopolamine Bromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216786",
"LabelerName": "i3 Pharmaceuticals, LLC",
"SubstanceName": "METHSCOPOLAMINE BROMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241218",
"SamplePackage": "N",
"IndicationAndUsage": "Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.",
"Description": "Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg contain methscopolamine bromide USP, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform. The chemical name for methscopolamine bromide is 3-Oxa-9-azoniatricyclo [3.3.1.0 2,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(s)-(1α, 2β, 4β, 5α, 7β)]- and the molecular weight is 398.30. The structural formula is represented below:. Methscopolamine Bromide Tablets, USP 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide USP. Methscopolamine Bromide Tablets, USP 5 mg for oral administration contain 5 mg of methscopolamine bromide USP. Inactive ingredients: microcrystalline cellulose NF, pregelatinized starch NF, colloidal silicon dioxide NF, magnesium stearate NF. Contains no lactose. FDA approved impurity specifications differs from the USP."
},
{
"NDCCode": "10019-016-02",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 PACKAGE (10019-016-02) > 20 mL in 1 VIAL, MULTI-DOSE (10019-016-29)",
"NDC11Code": "10019-0016-02",
"ProductNDC": "10019-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20101217",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017558",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-07-28"
},
{
"NDCCode": "11673-016-02",
"PackageDescription": "1 TUBE in 1 CARTON (11673-016-02) / 30 g in 1 TUBE",
"NDC11Code": "11673-0016-02",
"ProductNDC": "11673-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Athletes Foot",
"NonProprietaryName": "Butenafine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205181",
"LabelerName": "Target Corporation",
"SubstanceName": "BUTENAFINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Benzylamine Antifungal [EPC], Benzylamines [CS]",
"Status": "Active",
"LastUpdate": "2025-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171130",
"SamplePackage": "N",
"IndicationAndUsage": "cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. cures most jock itch and ringworm. relieves itching, burning, cracking, and scaling which accompany these conditions."
},
{
"NDCCode": "14445-016-02",
"PackageDescription": "10 kg in 1 DRUM (14445-016-02) ",
"NDC11Code": "14445-0016-02",
"ProductNDC": "14445-016",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Alogliptin Benzoate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "ALOGLIPTIN BENZOATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "30-JUN-16"
},
{
"NDCCode": "25225-016-02",
"PackageDescription": "2 CLOTH in 1 POUCH (25225-016-02)",
"NDC11Code": "25225-0016-02",
"ProductNDC": "25225-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100503",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Unique Holding Group Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "1/1001",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions. Adults and children two years and over: 1 Apply to hands, 2 Allow skin to dry without wiping.",
"Description": "Uses. To decrease bacteria on the skin that could cause diseases. Recommended for repeated use."
},
{
"NDCCode": "30805-016-02",
"PackageDescription": "1250 mL in 1 BAG (30805-016-02) ",
"NDC11Code": "30805-0016-02",
"ProductNDC": "30805-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Altra Antimicrobial Foaming Hand Wash With 0.3% Pcmx",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200415",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Buckeye International, Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200415",
"SamplePackage": "N",
"IndicationAndUsage": "Hand wash to help reduce bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "33332-016-01",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (33332-016-01) > .5 mL in 1 SYRINGE, GLASS (33332-016-02)",
"NDC11Code": "33332-0016-01",
"ProductNDC": "33332-016",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Afluria",
"NonProprietaryName": "Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (propiolactone Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20110715",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125254",
"LabelerName": "Seqirus Pty Ltd",
"SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient],Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "36800-016-02",
"PackageDescription": "1 TUBE in 1 CARTON (36800-016-02) > 28.4 g in 1 TUBE",
"NDC11Code": "36800-0016-02",
"ProductNDC": "36800-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare",
"ProprietaryNameSuffix": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19951214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "37012-016-02",
"PackageDescription": "1 TUBE in 1 CARTON (37012-016-02) > 28.4 g in 1 TUBE",
"NDC11Code": "37012-0016-02",
"ProductNDC": "37012-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shopko",
"ProprietaryNameSuffix": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19951214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Shopko Stores Operating Co., LLC",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "41163-016-02",
"PackageDescription": "1 TUBE in 1 CARTON (41163-016-02) > 28.4 g in 1 TUBE",
"NDC11Code": "41163-0016-02",
"ProductNDC": "41163-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline",
"ProprietaryNameSuffix": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19951214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Supervalu Inc",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "41701-016-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (41701-016-02) / 6 g in 1 BOTTLE, PLASTIC (41701-016-01) ",
"NDC11Code": "41701-0016-02",
"ProductNDC": "41701-016",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Terlipressin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110318",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Piramal Pharma Limited",
"SubstanceName": "TERLIPRESSIN",
"StrengthNumber": "6",
"StrengthUnit": "g/6g",
"Status": "Unfinished",
"LastUpdate": "2024-01-23",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "06-NOV-17"
},
{
"NDCCode": "42419-016-02",
"PackageDescription": "25 kg in 1 DRUM (42419-016-02)",
"NDC11Code": "42419-0016-02",
"ProductNDC": "42419-016",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Terazosin Hydrochloride Dihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120414",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CTX Lifesciences Pvt. Ltd.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "43328-016-02",
"PackageDescription": "2 POUCH in 1 CARTON (43328-016-02) / 1 FILM in 1 POUCH (43328-016-01) ",
"NDC11Code": "43328-0016-02",
"ProductNDC": "43328-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vybrique",
"NonProprietaryName": "Sildenafil Oral Film",
"DosageFormName": "FILM",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210858",
"LabelerName": "Altergon Italia SRL",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "Y"
},
{
"NDCCode": "44924-016-02",
"PackageDescription": "7 AMPULE in 1 BOX (44924-016-02) > 2 mL in 1 AMPULE (44924-016-01)",
"NDC11Code": "44924-0016-02",
"ProductNDC": "44924-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Babor Collagen Booster",
"NonProprietaryName": "Allantoin",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070501",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Babor Cosmetics America, Corp.",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": ".004",
"StrengthUnit": "mL/2mL",
"Status": "Deprecated",
"LastUpdate": "2017-07-25"
},
{
"NDCCode": "49035-016-02",
"PackageDescription": "1 TUBE in 1 CARTON (49035-016-02) / 28.4 g in 1 TUBE",
"NDC11Code": "49035-0016-02",
"ProductNDC": "49035-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19951214",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19951214",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "49349-016-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-016-02)",
"NDC11Code": "49349-0016-02",
"ProductNDC": "49349-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078402",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49351-016-02",
"PackageDescription": "4 BAG in 1 CARTON (49351-016-02) > 1100 mL in 1 BAG",
"NDC11Code": "49351-0016-02",
"ProductNDC": "49351-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tork Premium Hand Sanitizer Foam Alcohol-free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100303",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "SCA Tissue North America",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To decrease potentially harmful germs on skin."
},
{
"NDCCode": "49726-016-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (49726-016-02) > 59 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "49726-0016-02",
"ProductNDC": "49726-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Premensa",
"ProprietaryNameSuffix": "Pms Symptom Relief",
"NonProprietaryName": "Apis Mellifica, Chamomilla, Cimicifuga Racemosa, Cyclamen Europaeum, Helonias Dioca, Ignatia Amara, Lac Caninum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Platinum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110221",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hello Life, Inc.",
"SubstanceName": "APIS MELLIFERA; CHAMOMILE; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110221",
"SamplePackage": "N",
"IndicationAndUsage": "to temporarily relieve symptoms commonly associated with PMS, such as: 1 exhaustion, 2 dullness, 3 drowsiness, 4 muscle weakness.",
"Description": "30-day supply. dropper included. Premensa is made without alcohol or sugar; no gluten added."
},
{
"NDCCode": "50241-016-02",
"PackageDescription": "4 BOTTLE, PLASTIC in 1 BOX (50241-016-02) > 3.80564 kg in 1 BOTTLE, PLASTIC (50241-016-01) ",
"NDC11Code": "50241-0016-02",
"ProductNDC": "50241-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Premium Protection Antibacterial Hand",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180415",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "13",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2020-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180415",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72319-016-02</NDCCode>
<PackageDescription>60 TABLET in 1 CONTAINER (72319-016-02) </PackageDescription>
<NDC11Code>72319-0016-02</NDC11Code>
<ProductNDC>72319-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219464</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .</IndicationAndUsage>
<Description>Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>72319-016-60</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 CARTON (72319-016-60) / 10 TABLET in 1 BLISTER PACK (72319-016-10) </PackageDescription>
<NDC11Code>72319-0016-60</NDC11Code>
<ProductNDC>72319-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219464</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .</IndicationAndUsage>
<Description>Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>72319-003-02</NDCCode>
<PackageDescription>60 TABLET in 1 CONTAINER (72319-003-02) </PackageDescription>
<NDC11Code>72319-0003-02</NDC11Code>
<ProductNDC>72319-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219464</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .</IndicationAndUsage>
<Description>Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>72319-006-02</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (72319-006-02) </PackageDescription>
<NDC11Code>72319-0006-02</NDC11Code>
<ProductNDC>72319-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Selegiline Hydrochloride</ProprietaryName>
<NonProprietaryName>Selegiline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074672</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SELEGILINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Selegiline Hydrochloride Tablets, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).</IndicationAndUsage>
<Description>Selegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as 1-deprenyl. The chemical name is: (R)-(-)- N,2-dimethyl- N-2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.74. The molecular formula is C 13H 17NHCl. The structural formula is as follows:. Each tablet, for oral administration, contains 5 mg selegiline hydrochloride. Inactive ingredients are corn starch, lactose monohydrate, microcrystalline cellulose, povidone, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>72319-015-02</NDCCode>
<PackageDescription>60 TABLET in 1 CONTAINER (72319-015-02) </PackageDescription>
<NDC11Code>72319-0015-02</NDC11Code>
<ProductNDC>72319-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219464</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .</IndicationAndUsage>
<Description>Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>72319-017-02</NDCCode>
<PackageDescription>60 TABLET in 1 CONTAINER (72319-017-02) </PackageDescription>
<NDC11Code>72319-0017-02</NDC11Code>
<ProductNDC>72319-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219464</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: 1 Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1), 2 Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2, 5.5) .</IndicationAndUsage>
<Description>Everolimus tablets is a macrolide immunosuppressant. The chemical name of everolimus is. (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.0 4,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.25 g/mol. The structural formula is:. Everolimus tablets is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, anhydrous lactose, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>72319-021-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02) </PackageDescription>
<NDC11Code>72319-0021-02</NDC11Code>
<ProductNDC>72319-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213517</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina. Ranolazine Extended-Release Tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine Extended-Release Tablets is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine Extended-Release Tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, sodium hydroxide and magnesium stearate. Additional inactive ingredients for the 500 mg tablet include polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red; additional inactive ingredients for the 1000 mg tablet include hypromellose, polydextrose, titanium dioxide, talc, maltodextrin, medium chain triglycerides and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>72319-022-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-022-02) </PackageDescription>
<NDC11Code>72319-0022-02</NDC11Code>
<ProductNDC>72319-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213517</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina. Ranolazine Extended-Release Tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine Extended-Release Tablets is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine Extended-Release Tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, sodium hydroxide and magnesium stearate. Additional inactive ingredients for the 500 mg tablet include polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red; additional inactive ingredients for the 1000 mg tablet include hypromellose, polydextrose, titanium dioxide, talc, maltodextrin, medium chain triglycerides and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>72319-023-02</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (72319-023-02) </PackageDescription>
<NDC11Code>72319-0023-02</NDC11Code>
<ProductNDC>72319-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Posaconazole</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216488</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Posaconazole is an azole antifungal agent. Posaconazole is available as a delayed-release tablet intended for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with a molecular formula of C 37H 42F 2N 8O 4and a molecular weight of 700.8. The chemical structure is:. Posaconazole is a white to off white powder with a low aqueous solubility. Posaconazole delayed-release tablet is a yellow, oval shaped, film-coated tablet containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose acetate succinate, iron oxide yellow, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol 3350/4000, polyvinyl alcohol, silicon dioxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72319-024-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72319-024-02) </PackageDescription>
<NDC11Code>72319-0024-02</NDC11Code>
<ProductNDC>72319-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maraviroc</ProprietaryName>
<NonProprietaryName>Maraviroc</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217114</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MARAVIROC</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maraviroc is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use: 1 Maraviroc is not recommended in patients with dual/mixed- or CXCR4-tropic HIV- 1 [see Microbiology (12.4)] . .</IndicationAndUsage>
<Description>Maraviroc is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. Maraviroc film-coated tablets for oral administration contain 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue # 2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5- methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1- phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to off-white powder with a molecular weight of 513.68. It is very soluble in methanol and is highly soluble across the physiological pH range (pH 1.0 to 7.5).</Description>
</NDC>
<NDC>
<NDCCode>72319-025-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72319-025-02) </PackageDescription>
<NDC11Code>72319-0025-02</NDC11Code>
<ProductNDC>72319-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maraviroc</ProprietaryName>
<NonProprietaryName>Maraviroc</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217114</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MARAVIROC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maraviroc is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use: 1 Maraviroc is not recommended in patients with dual/mixed- or CXCR4-tropic HIV- 1 [see Microbiology (12.4)] . .</IndicationAndUsage>
<Description>Maraviroc is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. Maraviroc film-coated tablets for oral administration contain 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&C blue # 2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5- methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1- phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to off-white powder with a molecular weight of 513.68. It is very soluble in methanol and is highly soluble across the physiological pH range (pH 1.0 to 7.5).</Description>
</NDC>
<NDC>
<NDCCode>72319-030-02</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (72319-030-02) </PackageDescription>
<NDC11Code>72319-0030-02</NDC11Code>
<ProductNDC>72319-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methscopolamine Bromide</ProprietaryName>
<NonProprietaryName>Methscopolamine Bromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216786</ApplicationNumber>
<LabelerName>i3 Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHSCOPOLAMINE BROMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.</IndicationAndUsage>
<Description>Methscopolamine Bromide Tablets, USP 2.5 mg and 5 mg contain methscopolamine bromide USP, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform. The chemical name for methscopolamine bromide is 3-Oxa-9-azoniatricyclo [3.3.1.0 2,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(s)-(1α, 2β, 4β, 5α, 7β)]- and the molecular weight is 398.30. The structural formula is represented below:. Methscopolamine Bromide Tablets, USP 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide USP. Methscopolamine Bromide Tablets, USP 5 mg for oral administration contain 5 mg of methscopolamine bromide USP. Inactive ingredients: microcrystalline cellulose NF, pregelatinized starch NF, colloidal silicon dioxide NF, magnesium stearate NF. Contains no lactose. FDA approved impurity specifications differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>10019-016-02</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 PACKAGE (10019-016-02) > 20 mL in 1 VIAL, MULTI-DOSE (10019-016-29)</PackageDescription>
<NDC11Code>10019-0016-02</NDC11Code>
<ProductNDC>10019-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20101217</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017558</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-07-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>11673-016-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11673-016-02) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>11673-0016-02</NDC11Code>
<ProductNDC>11673-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Athletes Foot</ProprietaryName>
<NonProprietaryName>Butenafine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205181</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>BUTENAFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Benzylamine Antifungal [EPC], Benzylamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. cures most jock itch and ringworm. relieves itching, burning, cracking, and scaling which accompany these conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14445-016-02</NDCCode>
<PackageDescription>10 kg in 1 DRUM (14445-016-02) </PackageDescription>
<NDC11Code>14445-0016-02</NDC11Code>
<ProductNDC>14445-016</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Alogliptin Benzoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160630</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALOGLIPTIN BENZOATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-JUN-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>25225-016-02</NDCCode>
<PackageDescription>2 CLOTH in 1 POUCH (25225-016-02)</PackageDescription>
<NDC11Code>25225-0016-02</NDC11Code>
<ProductNDC>25225-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100503</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Unique Holding Group Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>1/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Adults and children two years and over: 1 Apply to hands, 2 Allow skin to dry without wiping.</IndicationAndUsage>
<Description>Uses. To decrease bacteria on the skin that could cause diseases. Recommended for repeated use.</Description>
</NDC>
<NDC>
<NDCCode>30805-016-02</NDCCode>
<PackageDescription>1250 mL in 1 BAG (30805-016-02) </PackageDescription>
<NDC11Code>30805-0016-02</NDC11Code>
<ProductNDC>30805-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Altra Antimicrobial Foaming Hand Wash With 0.3% Pcmx</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200415</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Buckeye International, Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand wash to help reduce bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33332-016-01</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (33332-016-01) > .5 mL in 1 SYRINGE, GLASS (33332-016-02)</PackageDescription>
<NDC11Code>33332-0016-01</NDC11Code>
<ProductNDC>33332-016</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Afluria</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (propiolactone Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20110715</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125254</ApplicationNumber>
<LabelerName>Seqirus Pty Ltd</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Pharm_Classes>Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient],Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>36800-016-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (36800-016-02) > 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>36800-0016-02</NDC11Code>
<ProductNDC>36800-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare</ProprietaryName>
<ProprietaryNameSuffix>Triple Antibiotic</ProprietaryNameSuffix>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19951214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37012-016-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37012-016-02) > 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>37012-0016-02</NDC11Code>
<ProductNDC>37012-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shopko</ProprietaryName>
<ProprietaryNameSuffix>Triple Antibiotic</ProprietaryNameSuffix>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19951214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Shopko Stores Operating Co., LLC</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41163-016-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (41163-016-02) > 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>41163-0016-02</NDC11Code>
<ProductNDC>41163-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline</ProprietaryName>
<ProprietaryNameSuffix>Triple Antibiotic</ProprietaryNameSuffix>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19951214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Supervalu Inc</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>first aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41701-016-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (41701-016-02) / 6 g in 1 BOTTLE, PLASTIC (41701-016-01) </PackageDescription>
<NDC11Code>41701-0016-02</NDC11Code>
<ProductNDC>41701-016</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Terlipressin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110318</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Piramal Pharma Limited</LabelerName>
<SubstanceName>TERLIPRESSIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>g/6g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-23</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-NOV-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>42419-016-02</NDCCode>
<PackageDescription>25 kg in 1 DRUM (42419-016-02)</PackageDescription>
<NDC11Code>42419-0016-02</NDC11Code>
<ProductNDC>42419-016</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Terazosin Hydrochloride Dihydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120414</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CTX Lifesciences Pvt. Ltd.</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43328-016-02</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (43328-016-02) / 1 FILM in 1 POUCH (43328-016-01) </PackageDescription>
<NDC11Code>43328-0016-02</NDC11Code>
<ProductNDC>43328-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vybrique</ProprietaryName>
<NonProprietaryName>Sildenafil Oral Film</NonProprietaryName>
<DosageFormName>FILM</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210858</ApplicationNumber>
<LabelerName>Altergon Italia SRL</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>44924-016-02</NDCCode>
<PackageDescription>7 AMPULE in 1 BOX (44924-016-02) > 2 mL in 1 AMPULE (44924-016-01)</PackageDescription>
<NDC11Code>44924-0016-02</NDC11Code>
<ProductNDC>44924-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Babor Collagen Booster</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Babor Cosmetics America, Corp.</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>.004</StrengthNumber>
<StrengthUnit>mL/2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-25</LastUpdate>
</NDC>
<NDC>
<NDCCode>49035-016-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (49035-016-02) / 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>49035-0016-02</NDC11Code>
<ProductNDC>49035-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19951214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-016-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-016-02)</PackageDescription>
<NDC11Code>49349-0016-02</NDC11Code>
<ProductNDC>49349-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078402</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49351-016-02</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (49351-016-02) > 1100 mL in 1 BAG</PackageDescription>
<NDC11Code>49351-0016-02</NDC11Code>
<ProductNDC>49351-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tork Premium Hand Sanitizer Foam Alcohol-free</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100303</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>SCA Tissue North America</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To decrease potentially harmful germs on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49726-016-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (49726-016-02) > 59 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>49726-0016-02</NDC11Code>
<ProductNDC>49726-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Premensa</ProprietaryName>
<ProprietaryNameSuffix>Pms Symptom Relief</ProprietaryNameSuffix>
<NonProprietaryName>Apis Mellifica, Chamomilla, Cimicifuga Racemosa, Cyclamen Europaeum, Helonias Dioca, Ignatia Amara, Lac Caninum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Platinum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110221</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hello Life, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; CHAMOMILE; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to temporarily relieve symptoms commonly associated with PMS, such as: 1 exhaustion, 2 dullness, 3 drowsiness, 4 muscle weakness.</IndicationAndUsage>
<Description>30-day supply. dropper included. Premensa is made without alcohol or sugar; no gluten added.</Description>
</NDC>
<NDC>
<NDCCode>50241-016-02</NDCCode>
<PackageDescription>4 BOTTLE, PLASTIC in 1 BOX (50241-016-02) > 3.80564 kg in 1 BOTTLE, PLASTIC (50241-016-01) </PackageDescription>
<NDC11Code>50241-0016-02</NDC11Code>
<ProductNDC>50241-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Premium Protection Antibacterial Hand</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>