{
"NDC": [
{
"NDCCode": "42211-205-29",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42211-205-29) ",
"NDC11Code": "42211-0205-29",
"ProductNDC": "42211-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivlodex",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207233",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151031",
"SamplePackage": "N",
"IndicationAndUsage": "VIVLODEX is indicated for management of osteoarthritis pain.",
"Description": "VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with \"IP-205\" imprinted in white ink and a dark blue cap with \"5 mg\" imprinted in white ink. The 10 mg capsules have a pink body with \"IP-206\" imprinted in white ink and a dark blue cap with \"10 mg\" imprinted in white ink."
},
{
"NDCCode": "42211-205-23",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42211-205-23) ",
"NDC11Code": "42211-0205-23",
"ProductNDC": "42211-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivlodex",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207233",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151031",
"SamplePackage": "N",
"IndicationAndUsage": "VIVLODEX is indicated for management of osteoarthritis pain.",
"Description": "VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with \"IP-205\" imprinted in white ink and a dark blue cap with \"5 mg\" imprinted in white ink. The 10 mg capsules have a pink body with \"IP-206\" imprinted in white ink and a dark blue cap with \"10 mg\" imprinted in white ink."
},
{
"NDCCode": "42211-205-41",
"PackageDescription": "1 CAPSULE in 1 BLISTER PACK (42211-205-41) ",
"NDC11Code": "42211-0205-41",
"ProductNDC": "42211-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivlodex",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207233",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151031",
"SamplePackage": "N",
"IndicationAndUsage": "VIVLODEX is indicated for management of osteoarthritis pain.",
"Description": "VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with \"IP-205\" imprinted in white ink and a dark blue cap with \"5 mg\" imprinted in white ink. The 10 mg capsules have a pink body with \"IP-206\" imprinted in white ink and a dark blue cap with \"10 mg\" imprinted in white ink."
},
{
"NDCCode": "57631-205-29",
"PackageDescription": "100 LOZENGE in 1 PACKAGE (57631-205-29) ",
"NDC11Code": "57631-0205-29",
"ProductNDC": "57631-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Herbomint Cough Drops",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20190522",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "InvaTech Pharma Solutions LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "9.99",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190522",
"SamplePackage": "N",
"IndicationAndUsage": "Natural way of calming cough and soothing sore throats."
},
{
"NDCCode": "79903-205-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (79903-205-01) / 29 mL in 1 BOTTLE",
"NDC11Code": "79903-0205-01",
"ProductNDC": "79903-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wrinkle Repair Moisturizer Spf 30",
"ProprietaryNameSuffix": "Eqb",
"NonProprietaryName": "Avobenzone 2% Homosalate 4% Octisalate 4% Octocrylene 2%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230811",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Walmart",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2; 4; 4; 2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230811",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn If used as directed with other sun protection measures ( see Oirections),decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "42211-201-29",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42211-201-29) ",
"NDC11Code": "42211-0201-29",
"ProductNDC": "42211-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tivorbex",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204768",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150706",
"SamplePackage": "N",
"IndicationAndUsage": "TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.",
"Description": "TIVORBEX (indomethacin) capsule is a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 20 mg and 40 mg for oral administration. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in TIVORBEX include: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2 and FD&C red #40. The imprinting on the gelatin capsules is white edible ink. The 20 mg capsules have a dark blue body imprinted with IP-201 and light blue cap imprinted with 20 mg in white ink. The 40 mg capsules have a dark blue body imprinted with IP-202 and blue cap imprinted with 40 mg in white ink."
},
{
"NDCCode": "42211-202-29",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42211-202-29) ",
"NDC11Code": "42211-0202-29",
"ProductNDC": "42211-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tivorbex",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204768",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150706",
"SamplePackage": "N",
"IndicationAndUsage": "TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.",
"Description": "TIVORBEX (indomethacin) capsule is a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 20 mg and 40 mg for oral administration. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in TIVORBEX include: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2 and FD&C red #40. The imprinting on the gelatin capsules is white edible ink. The 20 mg capsules have a dark blue body imprinted with IP-201 and light blue cap imprinted with 20 mg in white ink. The 40 mg capsules have a dark blue body imprinted with IP-202 and blue cap imprinted with 40 mg in white ink."
},
{
"NDCCode": "42211-203-29",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42211-203-29) ",
"NDC11Code": "42211-0203-29",
"ProductNDC": "42211-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zorvolex",
"NonProprietaryName": "Diclofenac",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204592",
"LabelerName": "Iroko Pharmaceuticals LLC",
"SubstanceName": "DICLOFENAC",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20131031",
"SamplePackage": "N",
"IndicationAndUsage": "ZORVOLEX is indicated for: 1 Management of mild to moderate acute pain, 2 Management of osteoarthritis pain.",
"Description": "ZORVOLEX (diclofenac) capsules are a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following chemical structure. Diclofenac acid is a white to slight yellowish crystalline powder. Diclofenac acid has a pKa of 4.18 and a logP of 3.03. It is practically insoluble in water and sparingly soluble in ethanol. The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink."
},
{
"NDCCode": "42211-204-29",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42211-204-29) ",
"NDC11Code": "42211-0204-29",
"ProductNDC": "42211-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zorvolex",
"NonProprietaryName": "Diclofenac",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204592",
"LabelerName": "Iroko Pharmaceuticals LLC",
"SubstanceName": "DICLOFENAC",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20131031",
"SamplePackage": "N",
"IndicationAndUsage": "ZORVOLEX is indicated for: 1 Management of mild to moderate acute pain, 2 Management of osteoarthritis pain.",
"Description": "ZORVOLEX (diclofenac) capsules are a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following chemical structure. Diclofenac acid is a white to slight yellowish crystalline powder. Diclofenac acid has a pKa of 4.18 and a logP of 3.03. It is practically insoluble in water and sparingly soluble in ethanol. The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink."
},
{
"NDCCode": "42211-206-29",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42211-206-29) ",
"NDC11Code": "42211-0206-29",
"ProductNDC": "42211-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivlodex",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207233",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151031",
"SamplePackage": "N",
"IndicationAndUsage": "VIVLODEX is indicated for management of osteoarthritis pain.",
"Description": "VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with \"IP-205\" imprinted in white ink and a dark blue cap with \"5 mg\" imprinted in white ink. The 10 mg capsules have a pink body with \"IP-206\" imprinted in white ink and a dark blue cap with \"10 mg\" imprinted in white ink."
},
{
"NDCCode": "42211-206-23",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42211-206-23) ",
"NDC11Code": "42211-0206-23",
"ProductNDC": "42211-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivlodex",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207233",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151031",
"SamplePackage": "N",
"IndicationAndUsage": "VIVLODEX is indicated for management of osteoarthritis pain.",
"Description": "VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with \"IP-205\" imprinted in white ink and a dark blue cap with \"5 mg\" imprinted in white ink. The 10 mg capsules have a pink body with \"IP-206\" imprinted in white ink and a dark blue cap with \"10 mg\" imprinted in white ink."
},
{
"NDCCode": "42211-206-41",
"PackageDescription": "1 CAPSULE in 1 BLISTER PACK (42211-206-41) ",
"NDC11Code": "42211-0206-41",
"ProductNDC": "42211-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vivlodex",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207233",
"LabelerName": "Iroko Pharmaceuticals, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151031",
"SamplePackage": "N",
"IndicationAndUsage": "VIVLODEX is indicated for management of osteoarthritis pain.",
"Description": "VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with \"IP-205\" imprinted in white ink and a dark blue cap with \"5 mg\" imprinted in white ink. The 10 mg capsules have a pink body with \"IP-206\" imprinted in white ink and a dark blue cap with \"10 mg\" imprinted in white ink."
},
{
"NDCCode": "0517-2901-01",
"PackageDescription": "1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL",
"NDC11Code": "00517-2901-01",
"ProductNDC": "0517-2901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Vialdx",
"NonProprietaryName": "Glucagon Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250819",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250819",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "0517-2901-10",
"PackageDescription": "10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL",
"NDC11Code": "00517-2901-10",
"ProductNDC": "0517-2901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Vialdx",
"NonProprietaryName": "Glucagon Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250819",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250819",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "10738-205-63",
"PackageDescription": "473 mL in 1 BOTTLE (10738-205-63) ",
"NDC11Code": "10738-0205-63",
"ProductNDC": "10738-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema Fast Healing Body Wash",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Genuine Virgin Aloe Corporation",
"SubstanceName": "OATMEAL",
"StrengthNumber": "15",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes poison ivy insect bites."
},
{
"NDCCode": "52000-032-42",
"PackageDescription": "1 POUCH in 1 BOX (52000-032-42) / 2 PATCH in 1 POUCH",
"NDC11Code": "52000-0032-42",
"ProductNDC": "52000-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Hot Medicated Patch",
"NonProprietaryName": "Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170621",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Universal Distribution Center LLC",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "205.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170621",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieve minor pain associated with: arthritis simple backache muscle strains bursitis tendonitis strains bruises cramps."
},
{
"NDCCode": "60429-205-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (60429-205-01) ",
"NDC11Code": "60429-0205-01",
"ProductNDC": "60429-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087128",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120402",
"SamplePackage": "N"
},
{
"NDCCode": "60429-205-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (60429-205-10) ",
"NDC11Code": "60429-0205-10",
"ProductNDC": "60429-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087128",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120402",
"SamplePackage": "N"
},
{
"NDCCode": "65219-200-05",
"PackageDescription": "1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05) ",
"NDC11Code": "65219-0200-05",
"ProductNDC": "65219-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temsirolimus",
"NonProprietaryName": "Temsirolimus",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207383",
"LabelerName": "Fresenius Kabi USA, LLC",
"Status": "Active",
"LastUpdate": "2020-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma.",
"Description": "Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent. Temsirolimus is a white to off-white powder with a molecular formula of C56H87NO16 and a molecular weight of 1030.30. It is non-hygroscopic. Temsirolimus is practically insoluble in water and soluble in alcohol. It has no ionizable functional groups, and its solubility is independent of pH. The chemical name of temsirolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydrox y-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone 4'-[2,2-bis(hydroxymethyl)propionate]; or Rapamycin, 42-[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate]. Temsirolimus injection, 25 mg/mL, is a clear, colorless to light yellow, non-aqueous, ethanolic, sterile solution. Temsirolimus injection requires two dilutions prior to intravenous infusion. Temsirolimus injection should be diluted only with the supplied DILUENT for Temsirolimus injection. DILUENT for Temsirolimus injection is a sterile, non-aqueous solution that is supplied with Temsirolimus injection, as a kit. Temsirolimus injection, 25 mg/mL:. Active ingredient: temsirolimus (25 mg/mL). Inactive ingredients: dehydrated alcohol (49.90% v/v), butylated hydroxy anisole (0.0003% w/v), butylated hydroxy toluene (0.002% w/v), propylene glycol (50.3% w/v), and anhydrous citric acid (0.0025% w/v). DILUENT for Temsirolimus injection:. Inactive ingredients: polysorbate 80 (40.0% w/v), polyethylene glycol 400 (42.8% w/v) and dehydrated alcohol (25.14% v/v). After the Temsirolimus injection vial has been diluted with DILUENT for Temsirolimus injection, in accordance with the instructions in section 2.5, the solution contains 35.04% alcohol. Temsirolimus injection and DILUENT for Temsirolimus injection are filled in clear glass vials with butyl rubber stoppers."
},
{
"NDCCode": "69366-205-09",
"PackageDescription": "1 TUBE in 1 CARTON (69366-205-09) > 30 mL in 1 TUBE",
"NDC11Code": "69366-0205-09",
"ProductNDC": "69366-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Everything Tinted Moisturizer Oil Free Broad Spectrum Spf 20",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "The Honest Company, Inc.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "13.6",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-11-29",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "72065-120-11",
"PackageDescription": "1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "72065-0120-11",
"ProductNDC": "72065-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Hypopen",
"ProprietaryNameSuffix": "0.5 Mg Auto-injector",
"NonProprietaryName": "Glucagon Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "Xeris Pharmaceuticals, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": ".5",
"StrengthUnit": "mg/.1mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "72065-120-12",
"PackageDescription": "2 POUCH in 1 CARTON (72065-120-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "72065-0120-12",
"ProductNDC": "72065-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Hypopen",
"ProprietaryNameSuffix": "0.5 Mg Auto-injector",
"NonProprietaryName": "Glucagon Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "Xeris Pharmaceuticals, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": ".5",
"StrengthUnit": "mg/.1mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "72065-121-11",
"PackageDescription": "1 POUCH in 1 CARTON (72065-121-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "72065-0121-11",
"ProductNDC": "72065-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Hypopen",
"ProprietaryNameSuffix": "1 Mg Auto-injector",
"NonProprietaryName": "Glucagon Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "Xeris Pharmaceuticals, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "72065-121-12",
"PackageDescription": "2 POUCH in 1 CARTON (72065-121-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "72065-0121-12",
"ProductNDC": "72065-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Hypopen",
"ProprietaryNameSuffix": "1 Mg Auto-injector",
"NonProprietaryName": "Glucagon Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "Xeris Pharmaceuticals, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "72065-131-11",
"PackageDescription": "1 POUCH in 1 CARTON (72065-131-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "72065-0131-11",
"ProductNDC": "72065-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Pfs",
"ProprietaryNameSuffix": "1 Mg Pre-filled Syringe",
"NonProprietaryName": "Glucagon Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "Xeris Pharmaceuticals, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "72065-131-12",
"PackageDescription": "2 POUCH in 1 CARTON (72065-131-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "72065-0131-12",
"ProductNDC": "72065-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Pfs",
"ProprietaryNameSuffix": "1 Mg Pre-filled Syringe",
"NonProprietaryName": "Glucagon Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "Xeris Pharmaceuticals, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "72065-140-11",
"PackageDescription": ".2 mL in 1 CARTON (72065-140-11) ",
"NDC11Code": "72065-0140-11",
"ProductNDC": "72065-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Kit",
"NonProprietaryName": "Glucagon Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211011",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "Xeris Pharmaceuticals, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211011",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "72065-141-11",
"PackageDescription": ".2 mL in 1 VIAL, GLASS (72065-141-11) ",
"NDC11Code": "72065-0141-11",
"ProductNDC": "72065-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Kit",
"ProprietaryNameSuffix": "Vial",
"NonProprietaryName": "Glucagon Injection, Solution",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20211011",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "Xeris Pharmaceuticals, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211011",
"SamplePackage": "N",
"IndicationAndUsage": "GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).",
"Description": "Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent."
},
{
"NDCCode": "72485-205-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (72485-205-12) > 120 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "72485-0205-12",
"ProductNDC": "72485-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capecitabine 500mg",
"NonProprietaryName": "Capecitabine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207456",
"LabelerName": "Armas Pharmaceuticals Inc.",
"SubstanceName": "CAPECITABINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": "Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for. Adjuvant Colon Cancer (1.1). – Patients with Dukes' C colon cancer. Metastatic Colorectal Cancer (1.1). – First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred. Metastatic Breast Cancer (1.2). – In combination with docetaxel after failure of prior anthracycline containing therapy. – As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen.",
"Description": "Capecitabine tablets USP are fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5- fluorouracil. The chemical name for Capecitabine, USP is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine has the following structural formula. Capecitabine, USP is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine tablets USP are supplied as capsule shaped, biconvex film coated tablets for oral administration. Each light pink-colored tablet contains 150 mg capecitabine and each dark pink-colored tablet contains 500 mg capecitabine. The inactive ingredients in Capecitabine tablets USP include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The light or dark pink film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, yellow iron oxide, and red iron oxide."
},
{
"NDCCode": "72865-205-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (72865-205-05) ",
"NDC11Code": "72865-0205-05",
"ProductNDC": "72865-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214790",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N·HCl is represented by the following structural formula. Sertraline hydrochloride is a white or off white crystalline powder that is sparingly soluble in methanol, dimethyl formamide and absolute alcohol; slightly soluble in water, acetone and isopropanol. Sertraline hydrochloride tablets, USP for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol and polysorbate 80. The 25 mg and 50 mg strength also contains FD&C blue no. 2. The 25 mg strength also contains D&C yellow no. 10 aluminum lake. 100 mg strength also contains iron oxide yellow, iron oxide red."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42211-205-29</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42211-205-29) </PackageDescription>
<NDC11Code>42211-0205-29</NDC11Code>
<ProductNDC>42211-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vivlodex</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207233</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIVLODEX is indicated for management of osteoarthritis pain.</IndicationAndUsage>
<Description>VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with "IP-205" imprinted in white ink and a dark blue cap with "5 mg" imprinted in white ink. The 10 mg capsules have a pink body with "IP-206" imprinted in white ink and a dark blue cap with "10 mg" imprinted in white ink.</Description>
</NDC>
<NDC>
<NDCCode>42211-205-23</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42211-205-23) </PackageDescription>
<NDC11Code>42211-0205-23</NDC11Code>
<ProductNDC>42211-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vivlodex</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207233</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIVLODEX is indicated for management of osteoarthritis pain.</IndicationAndUsage>
<Description>VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with "IP-205" imprinted in white ink and a dark blue cap with "5 mg" imprinted in white ink. The 10 mg capsules have a pink body with "IP-206" imprinted in white ink and a dark blue cap with "10 mg" imprinted in white ink.</Description>
</NDC>
<NDC>
<NDCCode>42211-205-41</NDCCode>
<PackageDescription>1 CAPSULE in 1 BLISTER PACK (42211-205-41) </PackageDescription>
<NDC11Code>42211-0205-41</NDC11Code>
<ProductNDC>42211-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vivlodex</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207233</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIVLODEX is indicated for management of osteoarthritis pain.</IndicationAndUsage>
<Description>VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with "IP-205" imprinted in white ink and a dark blue cap with "5 mg" imprinted in white ink. The 10 mg capsules have a pink body with "IP-206" imprinted in white ink and a dark blue cap with "10 mg" imprinted in white ink.</Description>
</NDC>
<NDC>
<NDCCode>57631-205-29</NDCCode>
<PackageDescription>100 LOZENGE in 1 PACKAGE (57631-205-29) </PackageDescription>
<NDC11Code>57631-0205-29</NDC11Code>
<ProductNDC>57631-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Herbomint Cough Drops</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190522</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>InvaTech Pharma Solutions LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>9.99</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Natural way of calming cough and soothing sore throats.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79903-205-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (79903-205-01) / 29 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>79903-0205-01</NDC11Code>
<ProductNDC>79903-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wrinkle Repair Moisturizer Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Eqb</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone 2% Homosalate 4% Octisalate 4% Octocrylene 2%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230811</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Walmart</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2; 4; 4; 2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn If used as directed with other sun protection measures ( see Oirections),decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42211-201-29</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42211-201-29) </PackageDescription>
<NDC11Code>42211-0201-29</NDC11Code>
<ProductNDC>42211-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tivorbex</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150706</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204768</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.</IndicationAndUsage>
<Description>TIVORBEX (indomethacin) capsule is a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 20 mg and 40 mg for oral administration. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in TIVORBEX include: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2 and FD&C red #40. The imprinting on the gelatin capsules is white edible ink. The 20 mg capsules have a dark blue body imprinted with IP-201 and light blue cap imprinted with 20 mg in white ink. The 40 mg capsules have a dark blue body imprinted with IP-202 and blue cap imprinted with 40 mg in white ink.</Description>
</NDC>
<NDC>
<NDCCode>42211-202-29</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42211-202-29) </PackageDescription>
<NDC11Code>42211-0202-29</NDC11Code>
<ProductNDC>42211-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tivorbex</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150706</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204768</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.</IndicationAndUsage>
<Description>TIVORBEX (indomethacin) capsule is a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 20 mg and 40 mg for oral administration. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in TIVORBEX include: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2 and FD&C red #40. The imprinting on the gelatin capsules is white edible ink. The 20 mg capsules have a dark blue body imprinted with IP-201 and light blue cap imprinted with 20 mg in white ink. The 40 mg capsules have a dark blue body imprinted with IP-202 and blue cap imprinted with 40 mg in white ink.</Description>
</NDC>
<NDC>
<NDCCode>42211-203-29</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42211-203-29) </PackageDescription>
<NDC11Code>42211-0203-29</NDC11Code>
<ProductNDC>42211-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zorvolex</ProprietaryName>
<NonProprietaryName>Diclofenac</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204592</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals LLC</LabelerName>
<SubstanceName>DICLOFENAC</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZORVOLEX is indicated for: 1 Management of mild to moderate acute pain, 2 Management of osteoarthritis pain.</IndicationAndUsage>
<Description>ZORVOLEX (diclofenac) capsules are a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following chemical structure. Diclofenac acid is a white to slight yellowish crystalline powder. Diclofenac acid has a pKa of 4.18 and a logP of 3.03. It is practically insoluble in water and sparingly soluble in ethanol. The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink.</Description>
</NDC>
<NDC>
<NDCCode>42211-204-29</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42211-204-29) </PackageDescription>
<NDC11Code>42211-0204-29</NDC11Code>
<ProductNDC>42211-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zorvolex</ProprietaryName>
<NonProprietaryName>Diclofenac</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204592</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals LLC</LabelerName>
<SubstanceName>DICLOFENAC</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZORVOLEX is indicated for: 1 Management of mild to moderate acute pain, 2 Management of osteoarthritis pain.</IndicationAndUsage>
<Description>ZORVOLEX (diclofenac) capsules are a nonsteroidal anti-inflammatory drug, available as hard gelatin capsules of 18 mg and 35 mg for oral administration. The chemical name is 2-[(2, 6-dichlorophenyl) amino] benzeneacetic acid. The molecular weight is 296.15. Its molecular formula is C14H11Cl2NO2, and it has the following chemical structure. Diclofenac acid is a white to slight yellowish crystalline powder. Diclofenac acid has a pKa of 4.18 and a logP of 3.03. It is practically insoluble in water and sparingly soluble in ethanol. The inactive ingredients in ZORVOLEX include a combination of lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, croscarmellose sodium and sodium stearyl fumarate. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #1, FD&C blue #2, FDA/E172 Yellow Iron Oxide and FDA/E172 Black Iron Oxide. The imprinting on the gelatin capsules is white edible ink. The 18 mg capsules have a blue body imprinted with IP-203 and light green cap imprinted with 18 mg in white ink. The 35 mg capsules have a blue body imprinted with IP-204 and green cap imprinted with 35 mg in white ink.</Description>
</NDC>
<NDC>
<NDCCode>42211-206-29</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42211-206-29) </PackageDescription>
<NDC11Code>42211-0206-29</NDC11Code>
<ProductNDC>42211-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vivlodex</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207233</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIVLODEX is indicated for management of osteoarthritis pain.</IndicationAndUsage>
<Description>VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with "IP-205" imprinted in white ink and a dark blue cap with "5 mg" imprinted in white ink. The 10 mg capsules have a pink body with "IP-206" imprinted in white ink and a dark blue cap with "10 mg" imprinted in white ink.</Description>
</NDC>
<NDC>
<NDCCode>42211-206-23</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42211-206-23) </PackageDescription>
<NDC11Code>42211-0206-23</NDC11Code>
<ProductNDC>42211-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vivlodex</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207233</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIVLODEX is indicated for management of osteoarthritis pain.</IndicationAndUsage>
<Description>VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with "IP-205" imprinted in white ink and a dark blue cap with "5 mg" imprinted in white ink. The 10 mg capsules have a pink body with "IP-206" imprinted in white ink and a dark blue cap with "10 mg" imprinted in white ink.</Description>
</NDC>
<NDC>
<NDCCode>42211-206-41</NDCCode>
<PackageDescription>1 CAPSULE in 1 BLISTER PACK (42211-206-41) </PackageDescription>
<NDC11Code>42211-0206-41</NDC11Code>
<ProductNDC>42211-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vivlodex</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207233</ApplicationNumber>
<LabelerName>Iroko Pharmaceuticals, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIVLODEX is indicated for management of osteoarthritis pain.</IndicationAndUsage>
<Description>VIVLODEX (meloxicam) capsules are a nonsteroidal anti-inflammatory drug, available as pink and blue capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C14H13N3O4S2, and it has the following chemical structure. Meloxicam is a pale yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app=0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in VIVLODEX include: lactose monohydrate, sodium lauryl sulfate, sodium stearyl fumarate, microcrystalline cellulose, and croscarmellose sodium. The capsule shells contain gelatin, titanium dioxide, and dyes FD&C blue #2, FD&C red #40, FD&C yellow #6, and carmine. The imprinting on the gelatin capsules is white edible ink. The 5 mg capsules have a light pink body with "IP-205" imprinted in white ink and a dark blue cap with "5 mg" imprinted in white ink. The 10 mg capsules have a pink body with "IP-206" imprinted in white ink and a dark blue cap with "10 mg" imprinted in white ink.</Description>
</NDC>
<NDC>
<NDCCode>0517-2901-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL</PackageDescription>
<NDC11Code>00517-2901-01</NDC11Code>
<ProductNDC>0517-2901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Vialdx</ProprietaryName>
<NonProprietaryName>Glucagon Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250819</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250819</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>0517-2901-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL</PackageDescription>
<NDC11Code>00517-2901-10</NDC11Code>
<ProductNDC>0517-2901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Vialdx</ProprietaryName>
<NonProprietaryName>Glucagon Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250819</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250819</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>10738-205-63</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (10738-205-63) </PackageDescription>
<NDC11Code>10738-0205-63</NDC11Code>
<ProductNDC>10738-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eczema Fast Healing Body Wash</ProprietaryName>
<NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
<DosageFormName>LOTION/SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Genuine Virgin Aloe Corporation</LabelerName>
<SubstanceName>OATMEAL</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes poison ivy insect bites.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52000-032-42</NDCCode>
<PackageDescription>1 POUCH in 1 BOX (52000-032-42) / 2 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>52000-0032-42</NDC11Code>
<ProductNDC>52000-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Hot Medicated Patch</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170621</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Universal Distribution Center LLC</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>205.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieve minor pain associated with: arthritis simple backache muscle strains bursitis tendonitis strains bruises cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60429-205-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60429-205-01) </PackageDescription>
<NDC11Code>60429-0205-01</NDC11Code>
<ProductNDC>60429-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087128</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC],Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60429-205-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (60429-205-10) </PackageDescription>
<NDC11Code>60429-0205-10</NDC11Code>
<ProductNDC>60429-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087128</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC],Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65219-200-05</NDCCode>
<PackageDescription>1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05) </PackageDescription>
<NDC11Code>65219-0200-05</NDC11Code>
<ProductNDC>65219-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temsirolimus</ProprietaryName>
<NonProprietaryName>Temsirolimus</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207383</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2020-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma.</IndicationAndUsage>
<Description>Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent. Temsirolimus is a white to off-white powder with a molecular formula of C56H87NO16 and a molecular weight of 1030.30. It is non-hygroscopic. Temsirolimus is practically insoluble in water and soluble in alcohol. It has no ionizable functional groups, and its solubility is independent of pH. The chemical name of temsirolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydrox y-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone 4'-[2,2-bis(hydroxymethyl)propionate]; or Rapamycin, 42-[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate]. Temsirolimus injection, 25 mg/mL, is a clear, colorless to light yellow, non-aqueous, ethanolic, sterile solution. Temsirolimus injection requires two dilutions prior to intravenous infusion. Temsirolimus injection should be diluted only with the supplied DILUENT for Temsirolimus injection. DILUENT for Temsirolimus injection is a sterile, non-aqueous solution that is supplied with Temsirolimus injection, as a kit. Temsirolimus injection, 25 mg/mL:. Active ingredient: temsirolimus (25 mg/mL). Inactive ingredients: dehydrated alcohol (49.90% v/v), butylated hydroxy anisole (0.0003% w/v), butylated hydroxy toluene (0.002% w/v), propylene glycol (50.3% w/v), and anhydrous citric acid (0.0025% w/v). DILUENT for Temsirolimus injection:. Inactive ingredients: polysorbate 80 (40.0% w/v), polyethylene glycol 400 (42.8% w/v) and dehydrated alcohol (25.14% v/v). After the Temsirolimus injection vial has been diluted with DILUENT for Temsirolimus injection, in accordance with the instructions in section 2.5, the solution contains 35.04% alcohol. Temsirolimus injection and DILUENT for Temsirolimus injection are filled in clear glass vials with butyl rubber stoppers.</Description>
</NDC>
<NDC>
<NDCCode>69366-205-09</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69366-205-09) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>69366-0205-09</NDC11Code>
<ProductNDC>69366-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Everything Tinted Moisturizer Oil Free Broad Spectrum Spf 20</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>The Honest Company, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>13.6</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-29</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>72065-120-11</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>72065-0120-11</NDC11Code>
<ProductNDC>72065-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Hypopen</ProprietaryName>
<ProprietaryNameSuffix>0.5 Mg Auto-injector</ProprietaryNameSuffix>
<NonProprietaryName>Glucagon Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>Xeris Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/.1mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>72065-120-12</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (72065-120-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>72065-0120-12</NDC11Code>
<ProductNDC>72065-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Hypopen</ProprietaryName>
<ProprietaryNameSuffix>0.5 Mg Auto-injector</ProprietaryNameSuffix>
<NonProprietaryName>Glucagon Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>Xeris Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/.1mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>72065-121-11</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (72065-121-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>72065-0121-11</NDC11Code>
<ProductNDC>72065-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Hypopen</ProprietaryName>
<ProprietaryNameSuffix>1 Mg Auto-injector</ProprietaryNameSuffix>
<NonProprietaryName>Glucagon Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>Xeris Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>72065-121-12</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (72065-121-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>72065-0121-12</NDC11Code>
<ProductNDC>72065-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Hypopen</ProprietaryName>
<ProprietaryNameSuffix>1 Mg Auto-injector</ProprietaryNameSuffix>
<NonProprietaryName>Glucagon Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>Xeris Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>72065-131-11</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (72065-131-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>72065-0131-11</NDC11Code>
<ProductNDC>72065-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Pfs</ProprietaryName>
<ProprietaryNameSuffix>1 Mg Pre-filled Syringe</ProprietaryNameSuffix>
<NonProprietaryName>Glucagon Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>Xeris Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>72065-131-12</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (72065-131-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>72065-0131-12</NDC11Code>
<ProductNDC>72065-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Pfs</ProprietaryName>
<ProprietaryNameSuffix>1 Mg Pre-filled Syringe</ProprietaryNameSuffix>
<NonProprietaryName>Glucagon Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>Xeris Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>72065-140-11</NDCCode>
<PackageDescription>.2 mL in 1 CARTON (72065-140-11) </PackageDescription>
<NDC11Code>72065-0140-11</NDC11Code>
<ProductNDC>72065-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Kit</ProprietaryName>
<NonProprietaryName>Glucagon Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211011</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>Xeris Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>72065-141-11</NDCCode>
<PackageDescription>.2 mL in 1 VIAL, GLASS (72065-141-11) </PackageDescription>
<NDC11Code>72065-0141-11</NDC11Code>
<ProductNDC>72065-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gvoke Kit</ProprietaryName>
<ProprietaryNameSuffix>Vial</ProprietaryNameSuffix>
<NonProprietaryName>Glucagon Injection, Solution</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20211011</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212097</ApplicationNumber>
<LabelerName>Xeris Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLUCAGON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes (1.1). GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2).</IndicationAndUsage>
<Description>Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is of synthetic origin produced by solid phase synthesis. Its molecular formula is C153H225N43O49S with the following structure:. GVOKE HypoPen, GVOKE PFS, and GVOKE Kit. GVOKE HypoPen (glucagon) injection, GVOKE PFS (glucagon) injection, and GVOKE Kit (glucagon) injection (these three presentations are also referred to as GVOKE (glucagon) injection in this labeling) are clear, colorless to pale yellow, sterile solutions for subcutaneous injection. : 1 GVOKE HypoPen and GVOKE PFS: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid in 209 mg dimethyl sulfoxide diluent., 2 GVOKE HypoPen: Each 0.1 mL contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid in 104 mg dimethyl sulfoxide diluent., 3 GVOKE Kit: Each 0.2 mL contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid in 205 mg dimethyl sulfoxide diluent.</Description>
</NDC>
<NDC>
<NDCCode>72485-205-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72485-205-12) > 120 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>72485-0205-12</NDC11Code>
<ProductNDC>72485-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capecitabine 500mg</ProprietaryName>
<NonProprietaryName>Capecitabine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207456</ApplicationNumber>
<LabelerName>Armas Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CAPECITABINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for. Adjuvant Colon Cancer (1.1). – Patients with Dukes' C colon cancer. Metastatic Colorectal Cancer (1.1). – First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred. Metastatic Breast Cancer (1.2). – In combination with docetaxel after failure of prior anthracycline containing therapy. – As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen.</IndicationAndUsage>
<Description>Capecitabine tablets USP are fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5- fluorouracil. The chemical name for Capecitabine, USP is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine has the following structural formula. Capecitabine, USP is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine tablets USP are supplied as capsule shaped, biconvex film coated tablets for oral administration. Each light pink-colored tablet contains 150 mg capecitabine and each dark pink-colored tablet contains 500 mg capecitabine. The inactive ingredients in Capecitabine tablets USP include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The light or dark pink film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, yellow iron oxide, and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>72865-205-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (72865-205-05) </PackageDescription>
<NDC11Code>72865-0205-05</NDC11Code>
<ProductNDC>72865-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214790</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine hydrochloride. The empirical formula C17H17Cl2N·HCl is represented by the following structural formula. Sertraline hydrochloride is a white or off white crystalline powder that is sparingly soluble in methanol, dimethyl formamide and absolute alcohol; slightly soluble in water, acetone and isopropanol. Sertraline hydrochloride tablets, USP for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol and polysorbate 80. The 25 mg and 50 mg strength also contains FD&C blue no. 2. The 25 mg strength also contains D&C yellow no. 10 aluminum lake. 100 mg strength also contains iron oxide yellow, iron oxide red.</Description>
</NDC>
</NDCList>