{
"NDC": [
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"ProductNDC": "36800-542",
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"ApplicationNumber": "NDA022429",
"LabelerName": "TOP CARE (Topco Associates LLC)",
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"StrengthUnit": "mg/1",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
{
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"StrengthUnit": "mg/1",
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{
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"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (36800-001-86) ",
"NDC11Code": "36800-0001-86",
"ProductNDC": "36800-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mouth Rinse",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
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{
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"NDC11Code": "36800-0015-86",
"ProductNDC": "36800-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Emerald Mint Health",
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"DosageFormName": "MOUTHWASH",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
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"LabelerName": "TopCo Associates LLC",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
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{
"NDCCode": "36800-072-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (36800-072-86) ",
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"NonProprietaryName": "Eucalyptol, Menthol, Methyol Salicylate, Thymol",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
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"LastUpdate": "2026-02-16",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19950707",
"SamplePackage": "N",
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{
"NDCCode": "36800-210-86",
"PackageDescription": "1 L in 1 BOTTLE, PLASTIC (36800-210-86)",
"NDC11Code": "36800-0210-86",
"ProductNDC": "36800-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Mouth Rinse",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "19920720",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".092; .042; .06; .064",
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"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
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},
{
"NDCCode": "36800-223-86",
"PackageDescription": "1 L in 1 BOTTLE, PLASTIC (36800-223-86) ",
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"ProductNDC": "36800-223",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Free Antiseptic Oral",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "19900215",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": ".07",
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"Status": "Deprecated",
"LastUpdate": "2021-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19900215",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "helps control plaque that leads to gingivitis."
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{
"NDCCode": "36800-318-86",
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"ProductNDC": "36800-318",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Original Antiseptic",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "19900715",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
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"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19900715",
"SamplePackage": "N",
"IndicationAndUsage": "helps control plaque that leads to gingivitis."
},
{
"NDCCode": "36800-434-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (36800-434-86) ",
"NDC11Code": "36800-0434-86",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tartar Control Plus",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "TopCo Associates, LLC",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20130801",
"SamplePackage": "N",
"IndicationAndUsage": "helps control plaque that leads to gingivitis."
},
{
"NDCCode": "36800-482-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (36800-482-86) ",
"NDC11Code": "36800-0482-86",
"ProductNDC": "36800-482",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol-free Anticavity",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130919",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130919",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "36800-543-86",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (36800-543-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC",
"NDC11Code": "36800-0543-86",
"ProductNDC": "36800-543",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hcl",
"NonProprietaryName": "Cetirizine Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260530",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022429",
"LabelerName": "TOP CARE (Topco Associates LLC)",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260530",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat."
},
{
"NDCCode": "36800-664-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (36800-664-86) ",
"NDC11Code": "36800-0664-86",
"ProductNDC": "36800-664",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antispetic",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "19921026",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "THYMOL; EUCALYPTOL; MENTHOL; METHYL SALICYLATE",
"StrengthNumber": ".64; .92; .42; .6",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19921026",
"SamplePackage": "N",
"IndicationAndUsage": "helps control plaque that leads to gingivitis."
},
{
"NDCCode": "36800-941-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (36800-941-86) ",
"NDC11Code": "36800-0941-86",
"ProductNDC": "36800-941",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tartar Control Plus",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130801",
"SamplePackage": "N",
"IndicationAndUsage": "helps control plaque that leads to gingivitis."
},
{
"NDCCode": "36800-971-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (36800-971-86) ",
"NDC11Code": "36800-0971-86",
"ProductNDC": "36800-971",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anticavity",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20130919",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130919",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "50458-542-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50458-542-60) ",
"NDC11Code": "50458-0542-60",
"ProductNDC": "50458-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokamet",
"NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140808",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204353",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "150; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140808",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
"Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
},
{
"NDCCode": "0004-0259-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-01) / 100 CAPSULE in 1 BOTTLE, PLASTIC",
"NDC11Code": "00004-0259-01",
"ProductNDC": "0004-0259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cellcept",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950503",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050722",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19950503",
"SamplePackage": "N",
"IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
},
{
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"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-43) / 500 CAPSULE in 1 BOTTLE, PLASTIC",
"NDC11Code": "00004-0259-43",
"ProductNDC": "0004-0259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cellcept",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950503",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050722",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
},
{
"NDCCode": "0004-0260-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "00004-0260-01",
"ProductNDC": "0004-0260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cellcept",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970619",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050723",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19970619",
"SamplePackage": "N",
"IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
},
{
"NDCCode": "0004-0260-43",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-43) / 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "00004-0260-43",
"ProductNDC": "0004-0260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cellcept",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970619",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050723",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
},
{
"NDCCode": "0004-0261-29",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0004-0261-29) / 225 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00004-0261-29",
"ProductNDC": "0004-0261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cellcept",
"NonProprietaryName": "Mycophenolate Mofetil",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19981001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050759",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MYCOPHENOLATE MOFETIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19981001",
"SamplePackage": "N",
"IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
},
{
"NDCCode": "0004-0298-09",
"PackageDescription": "4 VIAL in 1 CARTON (0004-0298-09) / 20 mL in 1 VIAL",
"NDC11Code": "00004-0298-09",
"ProductNDC": "0004-0298",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cellcept",
"NonProprietaryName": "Mycophenolate Mofetil Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050758",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "MYCOPHENOLATE MOFETIL HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980812",
"SamplePackage": "N",
"IndicationAndUsage": "CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
"Description": "CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
},
{
"NDCCode": "0074-3878-01",
"PackageDescription": "10 POWDER, FOR SOLUTION in 1 CARTON (0074-3878-01) ",
"NDC11Code": "00074-3878-01",
"ProductNDC": "0074-3878",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emblaveo",
"NonProprietaryName": "Aztreonam And Avibactam",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217906",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "AVIBACTAM; AZTREONAM",
"StrengthNumber": ".5; 1.5",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).",
"Description": "EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam. Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C13H17N5O8S2. Figure 1. Chemical structure of aztreonam. Avibactam. Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C7H10N3O6SNa. Figure 2. Chemical structure of avibactam sodium. EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial."
},
{
"NDCCode": "0074-3878-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01) ",
"NDC11Code": "00074-3878-10",
"ProductNDC": "0074-3878",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emblaveo",
"NonProprietaryName": "Aztreonam And Avibactam",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250207",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217906",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "AZTREONAM; AVIBACTAM",
"StrengthNumber": "127; 42.3",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250207",
"SamplePackage": "N",
"IndicationAndUsage": "EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).",
"Description": "EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam. Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C13H17N5O8S2. Figure 1. Chemical structure of aztreonam. Avibactam. Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C7H10N3O6SNa. Figure 2. Chemical structure of avibactam sodium. EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial."
},
{
"NDCCode": "11311-542-20",
"PackageDescription": "20 kg in 1 DRUM (11311-542-20)",
"NDC11Code": "11311-0542-20",
"ProductNDC": "11311-542",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Testosterone Propionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Biovet Joint Stock Company",
"SubstanceName": "TESTOSTERONE PROPIONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11673-542-12",
"PackageDescription": "1 KIT in 1 CARTON (11673-542-12) * 6 POWDER, FOR SOLUTION in 1 CARTON (11673-540-06) * 6 POWDER, FOR SOLUTION in 1 CARTON (11673-541-06) ",
"NDC11Code": "11673-0542-12",
"ProductNDC": "11673-542",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Severe Cold And Cough And Nighttime Severe Cold And Cough",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20170731",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Target Corporation",
"Status": "Active",
"LastUpdate": "2018-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170731",
"SamplePackage": "N"
},
{
"NDCCode": "13267-542-42",
"PackageDescription": "20 mL in 1 VIAL, GLASS (13267-542-42) ",
"NDC11Code": "13267-0542-42",
"ProductNDC": "13267-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Fluoride",
"ProprietaryNameSuffix": "F 18",
"NonProprietaryName": "Sodium Fluoride F 18",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204328",
"LabelerName": "THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH",
"SubstanceName": "SODIUM FLUORIDE F-18",
"StrengthNumber": "600",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2019-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141119",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity."
},
{
"NDCCode": "13537-542-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-542-02) > 4 g in 1 TUBE (13537-542-01)",
"NDC11Code": "13537-0542-02",
"ProductNDC": "13537-542",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Couleur Luxe Amplifier Xp",
"ProprietaryNameSuffix": "Amplifying Spf 15 - Corail Maximum",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".047; .009",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13668-542-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (13668-542-05) ",
"NDC11Code": "13668-0542-05",
"ProductNDC": "13668-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macitentan",
"NonProprietaryName": "Macitentan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211107",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "MACITENTAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"Description": "Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula. Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan tablets are available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: cellulose microcrystalline, magnesium stearate, mannitol 25, polysorbate 80, povidone K- 30, silicified microcrystalline cellulose, and sodium starch glycolate (Type-A). The tablets are film-coated with a coating material containing lecithin (soya), polyvinyl alcohol-part, hydrolyzed, talc, titanium dioxide, and xanthan gum."
},
{
"NDCCode": "13668-542-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-542-30) ",
"NDC11Code": "13668-0542-30",
"ProductNDC": "13668-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macitentan",
"NonProprietaryName": "Macitentan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211107",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "MACITENTAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"Description": "Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula. Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan tablets are available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: cellulose microcrystalline, magnesium stearate, mannitol 25, polysorbate 80, povidone K- 30, silicified microcrystalline cellulose, and sodium starch glycolate (Type-A). The tablets are film-coated with a coating material containing lecithin (soya), polyvinyl alcohol-part, hydrolyzed, talc, titanium dioxide, and xanthan gum."
}
]
}
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<NDC>
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<ProductNDC>36800-542</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hcl</ProprietaryName>
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<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
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<ProductNDC>36800-542</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
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<NDCCode>36800-001-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-001-86) </PackageDescription>
<NDC11Code>36800-0001-86</NDC11Code>
<ProductNDC>36800-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-015-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-015-86) </PackageDescription>
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<ProductNDC>36800-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Emerald Mint Health</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>TopCo Associates LLC</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>36800-072-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-072-86) </PackageDescription>
<NDC11Code>36800-0072-86</NDC11Code>
<ProductNDC>36800-072</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Mouth Rinse</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyol Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950707</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-210-86</NDCCode>
<PackageDescription>1 L in 1 BOTTLE, PLASTIC (36800-210-86)</PackageDescription>
<NDC11Code>36800-0210-86</NDC11Code>
<ProductNDC>36800-210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Mouth Rinse</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.092; .042; .06; .064</StrengthNumber>
<StrengthUnit>kg/100L; kg/100L; kg/100L; kg/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>36800-223-86</NDCCode>
<PackageDescription>1 L in 1 BOTTLE, PLASTIC (36800-223-86) </PackageDescription>
<NDC11Code>36800-0223-86</NDC11Code>
<ProductNDC>36800-223</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Free Antiseptic Oral</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>mg/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36800-299-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-299-86) </PackageDescription>
<NDC11Code>36800-0299-86</NDC11Code>
<ProductNDC>36800-299</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-318-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-318-86) </PackageDescription>
<NDC11Code>36800-0318-86</NDC11Code>
<ProductNDC>36800-318</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Original Antiseptic</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-434-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-434-86) </PackageDescription>
<NDC11Code>36800-0434-86</NDC11Code>
<ProductNDC>36800-434</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tartar Control Plus</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>TopCo Associates, LLC</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-482-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-482-86) </PackageDescription>
<NDC11Code>36800-0482-86</NDC11Code>
<ProductNDC>36800-482</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol-free Anticavity</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130919</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-543-86</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (36800-543-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>36800-0543-86</NDC11Code>
<ProductNDC>36800-543</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hcl</ProprietaryName>
<NonProprietaryName>Cetirizine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260530</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022429</ApplicationNumber>
<LabelerName>TOP CARE (Topco Associates LLC)</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-664-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-664-86) </PackageDescription>
<NDC11Code>36800-0664-86</NDC11Code>
<ProductNDC>36800-664</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antispetic</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921026</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>THYMOL; EUCALYPTOL; MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>.64; .92; .42; .6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19921026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-941-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-941-86) </PackageDescription>
<NDC11Code>36800-0941-86</NDC11Code>
<ProductNDC>36800-941</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tartar Control Plus</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-971-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (36800-971-86) </PackageDescription>
<NDC11Code>36800-0971-86</NDC11Code>
<ProductNDC>36800-971</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anticavity</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130919</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50458-542-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50458-542-60) </PackageDescription>
<NDC11Code>50458-0542-60</NDC11Code>
<ProductNDC>50458-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invokamet</ProprietaryName>
<NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140808</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204353</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.</IndicationAndUsage>
<Description>INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion.</Description>
</NDC>
<NDC>
<NDCCode>0004-0259-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-01) / 100 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00004-0259-01</NDC11Code>
<ProductNDC>0004-0259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cellcept</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950503</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050722</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)].</Description>
</NDC>
<NDC>
<NDCCode>0004-0259-43</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-43) / 500 CAPSULE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00004-0259-43</NDC11Code>
<ProductNDC>0004-0259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cellcept</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950503</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050722</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)].</Description>
</NDC>
<NDC>
<NDCCode>0004-0260-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00004-0260-01</NDC11Code>
<ProductNDC>0004-0260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cellcept</ProprietaryName>
<NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970619</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050723</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
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<IndicationAndUsage>CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)].</Description>
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<IndicationAndUsage>CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)].</Description>
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<IndicationAndUsage>CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)].</Description>
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<IndicationAndUsage>CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
<Description>CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide). Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)].</Description>
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<IndicationAndUsage>EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).</IndicationAndUsage>
<Description>EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam. Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C13H17N5O8S2. Figure 1. Chemical structure of aztreonam. Avibactam. Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C7H10N3O6SNa. Figure 2. Chemical structure of avibactam sodium. EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial.</Description>
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<IndicationAndUsage>EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).</IndicationAndUsage>
<Description>EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam. Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C13H17N5O8S2. Figure 1. Chemical structure of aztreonam. Avibactam. Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C7H10N3O6SNa. Figure 2. Chemical structure of avibactam sodium. EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial.</Description>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2018-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>20 mL in 1 VIAL, GLASS (13267-542-42) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Fluoride</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20141119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204328</ApplicationNumber>
<LabelerName>THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH</LabelerName>
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<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-26</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.</IndicationAndUsage>
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<NDC>
<NDCCode>13537-542-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-542-02) > 4 g in 1 TUBE (13537-542-01)</PackageDescription>
<NDC11Code>13537-0542-02</NDC11Code>
<ProductNDC>13537-542</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Couleur Luxe Amplifier Xp</ProprietaryName>
<ProprietaryNameSuffix>Amplifying Spf 15 - Corail Maximum</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
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<StartMarketingDate>20130527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.047; .009</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<NDC>
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<PackageDescription>500 TABLET in 1 BOTTLE (13668-542-05) </PackageDescription>
<NDC11Code>13668-0542-05</NDC11Code>
<ProductNDC>13668-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macitentan</ProprietaryName>
<NonProprietaryName>Macitentan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211107</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>MACITENTAN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
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<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
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<Description>Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula. Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan tablets are available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: cellulose microcrystalline, magnesium stearate, mannitol 25, polysorbate 80, povidone K- 30, silicified microcrystalline cellulose, and sodium starch glycolate (Type-A). The tablets are film-coated with a coating material containing lecithin (soya), polyvinyl alcohol-part, hydrolyzed, talc, titanium dioxide, and xanthan gum.</Description>
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<NDCCode>13668-542-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-542-30) </PackageDescription>
<NDC11Code>13668-0542-30</NDC11Code>
<ProductNDC>13668-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macitentan</ProprietaryName>
<NonProprietaryName>Macitentan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211107</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>MACITENTAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula. Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan tablets are available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: cellulose microcrystalline, magnesium stearate, mannitol 25, polysorbate 80, povidone K- 30, silicified microcrystalline cellulose, and sodium starch glycolate (Type-A). The tablets are film-coated with a coating material containing lecithin (soya), polyvinyl alcohol-part, hydrolyzed, talc, titanium dioxide, and xanthan gum.</Description>
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