{
"NDC": [
{
"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": "72319-003-02",
"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": "72319-016-02",
"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": "72319-017-02",
"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": "72319-024-02",
"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": "11673-023-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (11673-023-02) > 24 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "11673-0023-02",
"ProductNDC": "11673-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150401",
"EndMarketingDate": "20210731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091429",
"LabelerName": "Target Corporation",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150401",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
},
{
"NDCCode": "13537-023-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (13537-023-02) > 3 mL in 1 BOTTLE (13537-023-01)",
"NDC11Code": "13537-0023-02",
"ProductNDC": "13537-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Effet Parfait",
"ProprietaryNameSuffix": "Natural Finish Moisturizing Foundation Spf 25",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110810",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation Ltd.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".065; .016",
"StrengthUnit": "mL/mL; mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn."
},
{
"NDCCode": "14445-023-02",
"PackageDescription": "1 kg in 1 DRUM (14445-023-02) ",
"NDC11Code": "14445-0023-02",
"ProductNDC": "14445-023",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240306",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CV",
"Status": "Unfinished",
"LastUpdate": "2025-11-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "06-MAR-24"
},
{
"NDCCode": "14783-023-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-023-02) > 4 g in 1 TUBE (14783-023-01)",
"NDC11Code": "14783-0023-02",
"ProductNDC": "14783-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20",
"ProprietaryNameSuffix": "(mandarine) - Orange",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".071; .16",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-023-02",
"PackageDescription": "60 TABLET in 1 BOTTLE (16714-023-02)",
"NDC11Code": "16714-0023-02",
"ProductNDC": "16714-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078213",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-09-05"
},
{
"NDCCode": "17333-023-02",
"PackageDescription": "50 kg in 1 DRUM (17333-023-02) ",
"NDC11Code": "17333-0023-02",
"ProductNDC": "17333-023",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lysine Monohydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20020628",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Ajinomoto Company, Inc.",
"SubstanceName": "LYSINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "28-JUN-02"
},
{
"NDCCode": "24488-023-02",
"PackageDescription": "104 mL in 1 CANISTER (24488-023-02)",
"NDC11Code": "24488-0023-02",
"ProductNDC": "24488-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Duane Reade",
"ProprietaryNameSuffix": "Hot And Cold Balm",
"NonProprietaryName": "Methyl Salicylate And Menthol",
"DosageFormName": "SALVE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Duane Reade",
"SubstanceName": "METHYL SALICYLATE; MENTHOL",
"StrengthNumber": "30.16; 7.9",
"StrengthUnit": "mL/104mL; mL/104mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "use only as directed. avoid contact with eyes or mucous membranes. do not bandage tightly or with a heating pad. do not apply to wounds or damaged skin."
},
{
"NDCCode": "25225-023-02",
"PackageDescription": "59 g in 1 BOTTLE, PLASTIC (25225-023-02)",
"NDC11Code": "25225-0023-02",
"ProductNDC": "25225-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aqua Sunset Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101113",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Unique Holding Group Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "26052-023-02",
"PackageDescription": "24 PACKET in 1 BAG (26052-023-02) > 3 g in 1 PACKET",
"NDC11Code": "26052-0023-02",
"ProductNDC": "26052-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Throat Drops Honey",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"EndMarketingDate": "20211211",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "BURT'S BEES, INC.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/3g",
"Status": "Deprecated",
"LastUpdate": "2021-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20111101",
"EndMarketingDatePackage": "20211211",
"SamplePackage": "N"
},
{
"NDCCode": "27495-023-02",
"PackageDescription": "72 g in 1 JAR (27495-023-02) ",
"NDC11Code": "27495-0023-02",
"ProductNDC": "27495-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Overtime-hmp",
"NonProprietaryName": "Pain Relief Stick",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Physicians Science and Nature, Inc.",
"SubstanceName": "MENTHOL; METHYL SALICYLATE; CAPSAICIN",
"StrengthNumber": "15; 25; .075",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200731",
"SamplePackage": "N"
},
{
"NDCCode": "41163-023-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (41163-023-02) > 60 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "41163-0023-02",
"ProductNDC": "41163-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20160531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207957",
"LabelerName": "Supervalu Inc",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160703",
"EndMarketingDatePackage": "20230101",
"SamplePackage": "N"
},
{
"NDCCode": "42658-023-02",
"PackageDescription": "10 BOX in 1 CARTON (42658-023-02) / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "42658-0023-02",
"ProductNDC": "42658-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Micafungin",
"NonProprietaryName": "Micafungin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219712",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "MICAFUNGIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "Micafungin for Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]. , 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]. , 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)]. .",
"Description": "Micafungin for Injection USP is a sterile, lyophilized product for intravenous (IV) infusion that contains Micafungin Sodium USP. Micafungin Sodium USP is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg Micafungin Sodium USP) or 100 mg micafungin (equivalent to 101.73 mg Micafungin Sodium USP), 200 mg lactose monohydrate, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for Injection USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5-7. Micafungin Sodium USP is chemically designated as. Pneumocandin A0,1-[(4 R,5 R)-4,5-dihydroxy- N 2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4 S)4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of Micafungin Sodium USP is. The empirical/molecular formula is C 56H 70N 9NaO 23S and the formula weight is 1292.26. Micafungin Sodium USP is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane."
},
{
"NDCCode": "43419-023-02",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (43419-023-02) > 30 mL in 1 BOTTLE, PUMP",
"NDC11Code": "43419-0023-02",
"ProductNDC": "43419-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sulwhasoo Evenfair Smoothing Foundation",
"ProprietaryNameSuffix": "Spf25 No. 2 Medium Beige",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121123",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "1.95",
"StrengthUnit": "g/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20121123",
"SamplePackage": "N"
},
{
"NDCCode": "49349-023-02",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49349-023-02)",
"NDC11Code": "49349-0023-02",
"ProductNDC": "49349-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170418",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078597",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-05-02"
},
{
"NDCCode": "49726-023-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (49726-023-02) > 59 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "49726-0023-02",
"ProductNDC": "49726-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Goutinex",
"ProprietaryNameSuffix": "Gout Symptom Relief",
"NonProprietaryName": "Actaea Spicata, Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Phytolacca Decandra, Rhododendron Chrysanthum, Salicylicum Acidum, Urtica Urens",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hello Life, Inc.",
"SubstanceName": "ACTAEA SPICATA ROOT; AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; SALICYLIC ACID; URTICA URENS; LEDUM PALUSTRE TWIG; FRAXINUS EXCELSIOR LEAF",
"StrengthNumber": "10; 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; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20111109",
"SamplePackage": "N",
"IndicationAndUsage": "to temporarily relieve symptoms commonly associated with gout, such as: 1 exhaustion, 2 dullness, 3 drowsiness, 4 muscle weakness.",
"Description": "30-day supply. dropper included. Goutinex is made without alcohol or sugar; no gluten added."
},
{
"NDCCode": "49967-023-02",
"PackageDescription": "100 mL in 1 TUBE (49967-023-02) ",
"NDC11Code": "49967-0023-02",
"ProductNDC": "49967-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140801",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne."
},
{
"NDCCode": "50632-023-02",
"PackageDescription": "10 VIAL in 1 CARTON (50632-023-02) / .5 mL in 1 VIAL (50632-023-04) ",
"NDC11Code": "50632-0023-02",
"ProductNDC": "50632-023",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Jynneos",
"NonProprietaryName": "Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125678",
"LabelerName": "Bavarian Nordic A/S",
"SubstanceName": "VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN",
"StrengthNumber": "50000000",
"StrengthUnit": "1/.5mL",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250214",
"SamplePackage": "N",
"IndicationAndUsage": "JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.",
"Description": "JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex."
},
{
"NDCCode": "51824-023-02",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (51824-023-02)",
"NDC11Code": "51824-0023-02",
"ProductNDC": "51824-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Freshscent Anti-perspirant Deodorant",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120614",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part350",
"LabelerName": "New World Imports, Inc.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "13",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-08-15"
},
{
"NDCCode": "52119-023-02",
"PackageDescription": "2 kg in 1 DRUM (52119-023-02) ",
"NDC11Code": "52119-0023-02",
"ProductNDC": "52119-023",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pentosan Polysulfate Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230110",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Swati Spentose Private Limited",
"SubstanceName": "PENTOSAN POLYSULFATE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-02-03",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "10-JAN-23"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>72319-003-02</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>72319-016-02</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>72319-017-02</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>72319-024-02</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>11673-023-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-023-02) > 24 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0023-02</NDC11Code>
<ProductNDC>11673-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150401</StartMarketingDate>
<EndMarketingDate>20210731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091429</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150401</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-023-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (13537-023-02) > 3 mL in 1 BOTTLE (13537-023-01)</PackageDescription>
<NDC11Code>13537-0023-02</NDC11Code>
<ProductNDC>13537-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Effet Parfait</ProprietaryName>
<ProprietaryNameSuffix>Natural Finish Moisturizing Foundation Spf 25</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.065; .016</StrengthNumber>
<StrengthUnit>mL/mL; mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides moderate protection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14445-023-02</NDCCode>
<PackageDescription>1 kg in 1 DRUM (14445-023-02) </PackageDescription>
<NDC11Code>14445-0023-02</NDC11Code>
<ProductNDC>14445-023</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240306</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2025-11-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-MAR-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14783-023-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-023-02) > 4 g in 1 TUBE (14783-023-01)</PackageDescription>
<NDC11Code>14783-0023-02</NDC11Code>
<ProductNDC>14783-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Hydratess Long-lasting Intense Moisturizing Spf 20</ProprietaryName>
<ProprietaryNameSuffix>(mandarine) - Orange</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.071; .16</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-023-02</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16714-023-02)</PackageDescription>
<NDC11Code>16714-0023-02</NDC11Code>
<ProductNDC>16714-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078213</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-09-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>17333-023-02</NDCCode>
<PackageDescription>50 kg in 1 DRUM (17333-023-02) </PackageDescription>
<NDC11Code>17333-0023-02</NDC11Code>
<ProductNDC>17333-023</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lysine Monohydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20020628</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Ajinomoto Company, Inc.</LabelerName>
<SubstanceName>LYSINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-JUN-02</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>24488-023-02</NDCCode>
<PackageDescription>104 mL in 1 CANISTER (24488-023-02)</PackageDescription>
<NDC11Code>24488-0023-02</NDC11Code>
<ProductNDC>24488-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Duane Reade</ProprietaryName>
<ProprietaryNameSuffix>Hot And Cold Balm</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate And Menthol</NonProprietaryName>
<DosageFormName>SALVE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Duane Reade</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL</SubstanceName>
<StrengthNumber>30.16; 7.9</StrengthNumber>
<StrengthUnit>mL/104mL; mL/104mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>use only as directed. avoid contact with eyes or mucous membranes. do not bandage tightly or with a heating pad. do not apply to wounds or damaged skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>25225-023-02</NDCCode>
<PackageDescription>59 g in 1 BOTTLE, PLASTIC (25225-023-02)</PackageDescription>
<NDC11Code>25225-0023-02</NDC11Code>
<ProductNDC>25225-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aqua Sunset Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Unique Holding Group Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>26052-023-02</NDCCode>
<PackageDescription>24 PACKET in 1 BAG (26052-023-02) > 3 g in 1 PACKET</PackageDescription>
<NDC11Code>26052-0023-02</NDC11Code>
<ProductNDC>26052-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Throat Drops Honey</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<EndMarketingDate>20211211</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>BURT'S BEES, INC.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/3g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20111101</StartMarketingDatePackage>
<EndMarketingDatePackage>20211211</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>27495-023-02</NDCCode>
<PackageDescription>72 g in 1 JAR (27495-023-02) </PackageDescription>
<NDC11Code>27495-0023-02</NDC11Code>
<ProductNDC>27495-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Overtime-hmp</ProprietaryName>
<NonProprietaryName>Pain Relief Stick</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Physicians Science and Nature, Inc.</LabelerName>
<SubstanceName>MENTHOL; METHYL SALICYLATE; CAPSAICIN</SubstanceName>
<StrengthNumber>15; 25; .075</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41163-023-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41163-023-02) > 60 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>41163-0023-02</NDC11Code>
<ProductNDC>41163-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20160531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207957</ApplicationNumber>
<LabelerName>Supervalu Inc</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160703</StartMarketingDatePackage>
<EndMarketingDatePackage>20230101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42658-023-02</NDCCode>
<PackageDescription>10 BOX in 1 CARTON (42658-023-02) / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>42658-0023-02</NDC11Code>
<ProductNDC>42658-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Micafungin</ProprietaryName>
<NonProprietaryName>Micafungin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219712</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MICAFUNGIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Micafungin for Injection is indicated for: 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]. , 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]. , 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)]. .</IndicationAndUsage>
<Description>Micafungin for Injection USP is a sterile, lyophilized product for intravenous (IV) infusion that contains Micafungin Sodium USP. Micafungin Sodium USP is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg Micafungin Sodium USP) or 100 mg micafungin (equivalent to 101.73 mg Micafungin Sodium USP), 200 mg lactose monohydrate, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for Injection USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5-7. Micafungin Sodium USP is chemically designated as. Pneumocandin A0,1-[(4 R,5 R)-4,5-dihydroxy- N 2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4 S)4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of Micafungin Sodium USP is. The empirical/molecular formula is C 56H 70N 9NaO 23S and the formula weight is 1292.26. Micafungin Sodium USP is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.</Description>
</NDC>
<NDC>
<NDCCode>43419-023-02</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (43419-023-02) > 30 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>43419-0023-02</NDC11Code>
<ProductNDC>43419-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sulwhasoo Evenfair Smoothing Foundation</ProprietaryName>
<ProprietaryNameSuffix>Spf25 No. 2 Medium Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>1.95</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49349-023-02</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49349-023-02)</PackageDescription>
<NDC11Code>49349-0023-02</NDC11Code>
<ProductNDC>49349-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170418</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078597</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49726-023-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (49726-023-02) > 59 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>49726-0023-02</NDC11Code>
<ProductNDC>49726-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Goutinex</ProprietaryName>
<ProprietaryNameSuffix>Gout Symptom Relief</ProprietaryNameSuffix>
<NonProprietaryName>Actaea Spicata, Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Phytolacca Decandra, Rhododendron Chrysanthum, Salicylicum Acidum, Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111109</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hello Life, Inc.</LabelerName>
<SubstanceName>ACTAEA SPICATA ROOT; AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; SALICYLIC ACID; URTICA URENS; LEDUM PALUSTRE TWIG; FRAXINUS EXCELSIOR LEAF</SubstanceName>
<StrengthNumber>10; 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; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to temporarily relieve symptoms commonly associated with gout, such as: 1 exhaustion, 2 dullness, 3 drowsiness, 4 muscle weakness.</IndicationAndUsage>
<Description>30-day supply. dropper included. Goutinex is made without alcohol or sugar; no gluten added.</Description>
</NDC>
<NDC>
<NDCCode>49967-023-02</NDCCode>
<PackageDescription>100 mL in 1 TUBE (49967-023-02) </PackageDescription>
<NDC11Code>49967-0023-02</NDC11Code>
<ProductNDC>49967-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50632-023-02</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50632-023-02) / .5 mL in 1 VIAL (50632-023-04) </PackageDescription>
<NDC11Code>50632-0023-02</NDC11Code>
<ProductNDC>50632-023</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Jynneos</ProprietaryName>
<NonProprietaryName>Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125678</ApplicationNumber>
<LabelerName>Bavarian Nordic A/S</LabelerName>
<SubstanceName>VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN</SubstanceName>
<StrengthNumber>50000000</StrengthNumber>
<StrengthUnit>1/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.</IndicationAndUsage>
<Description>JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>51824-023-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (51824-023-02)</PackageDescription>
<NDC11Code>51824-0023-02</NDC11Code>
<ProductNDC>51824-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Freshscent Anti-perspirant Deodorant</ProprietaryName>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120614</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>New World Imports, Inc.</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-08-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>52119-023-02</NDCCode>
<PackageDescription>2 kg in 1 DRUM (52119-023-02) </PackageDescription>
<NDC11Code>52119-0023-02</NDC11Code>
<ProductNDC>52119-023</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pentosan Polysulfate Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230110</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Swati Spentose Private Limited</LabelerName>
<SubstanceName>PENTOSAN POLYSULFATE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-02-03</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-JAN-23</StartMarketingDatePackage>
</NDC>
</NDCList>