{
"NDC": [
{
"NDCCode": "53247-102-53",
"PackageDescription": "24 g in 1 TUBE (53247-102-53) ",
"NDC11Code": "53247-0102-53",
"ProductNDC": "53247-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Security",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150115",
"SamplePackage": "N"
},
{
"NDCCode": "53247-102-51",
"PackageDescription": "4.25 g in 1 PACKET (53247-102-51) ",
"NDC11Code": "53247-0102-51",
"ProductNDC": "53247-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Security",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150115",
"SamplePackage": "N"
},
{
"NDCCode": "53247-102-52",
"PackageDescription": "17 g in 1 TUBE (53247-102-52) ",
"NDC11Code": "53247-0102-52",
"ProductNDC": "53247-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Security",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150115",
"SamplePackage": "N"
},
{
"NDCCode": "53247-102-54",
"PackageDescription": "43 g in 1 TUBE (53247-102-54) ",
"NDC11Code": "53247-0102-54",
"ProductNDC": "53247-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Security",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150115",
"SamplePackage": "N"
},
{
"NDCCode": "53247-102-55",
"PackageDescription": "130 g in 1 TUBE (53247-102-55) ",
"NDC11Code": "53247-0102-55",
"ProductNDC": "53247-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Maximum Security",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "ORAL",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150115",
"SamplePackage": "N"
},
{
"NDCCode": "25000-102-53",
"PackageDescription": "4 BAG in 1 BOX (25000-102-53) / 1500 TABLET, EXTENDED RELEASE in 1 BAG",
"NDC11Code": "25000-0102-53",
"ProductNDC": "25000-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090295",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160512",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride.The chemical name of Metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-Release Tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets, 500 mg or 750 mg contains the inactive ingredients colloidal silicon dioxide, hypromellose and magnesium stearate."
},
{
"NDCCode": "37205-102-53",
"PackageDescription": "12 SUPPOSITORY in 1 CARTON (37205-102-53)",
"NDC11Code": "37205-0102-53",
"ProductNDC": "37205-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "19970910",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "CARDINAL HEALTH, INC.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1 hour."
},
{
"NDCCode": "43353-102-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (43353-102-53) ",
"NDC11Code": "43353-0102-53",
"ProductNDC": "43353-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203374",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150925",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].",
"Description": "Carisoprodol tablets, USP are available as 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in Carisoprodol tablets USP, 350 mg include microcrystalline cellulose, lactose monohydrate, pregelatinized starch (botanical source: maize), croscarmellose sodium, povidone, silicon dioxide and magnesium stearate."
},
{
"NDCCode": "52807-102-53",
"PackageDescription": "1000 mL in 1 BOTTLE (52807-102-53) ",
"NDC11Code": "52807-0102-53",
"ProductNDC": "52807-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200320",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangdong Longtai Industry Co.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skinre commended for repeated use."
},
{
"NDCCode": "57353-102-63",
"PackageDescription": "2 BOX in 1 BOX (57353-102-63) > 1 TUBE in 1 BOX (57353-102-53) > 74 g in 1 TUBE (57353-102-13)",
"NDC11Code": "57353-0102-63",
"ProductNDC": "57353-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Power White 7",
"ProprietaryNameSuffix": "Everyday Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20121201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "DENTOVATIONS INC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".24",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "69219-102-53",
"PackageDescription": "1 BOTTLE, PUMP in 1 BOX (69219-102-53) / 300 g in 1 BOTTLE, PUMP",
"NDC11Code": "69219-0102-53",
"ProductNDC": "69219-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eclipse Spf 50",
"ProprietaryNameSuffix": "All Shades",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SCIENCE OF SKINCARE LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "5.2; 1.1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": " Helps hydrate and prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "71112-102-53",
"PackageDescription": "1 TUBE in 1 BOX (71112-102-53) > 90 mg in 1 TUBE (71112-102-13) ",
"NDC11Code": "71112-0102-53",
"ProductNDC": "71112-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Black Is White",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20170129",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CURADEN AG",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".095",
"StrengthUnit": "mg/mg",
"Status": "Deprecated",
"LastUpdate": "2020-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170129",
"SamplePackage": "N"
},
{
"NDCCode": "73069-102-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-102-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0102-53",
"ProductNDC": "73069-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-mesenchyme",
"NonProprietaryName": "Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; PRASTERONE; MALIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); FUCUS VESICULOSUS; HISTIDINE; HYALURONIDASE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); LACTIC ACID; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SUS SCROFA MESENCHYME; NADIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; PHENYLALANINE; PROLACTIN; RANCID BEEF; THUJA OCCIDENTALIS LEAF; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; TYROSINE",
"StrengthNumber": "201; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 201; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Endoglycosidase [EPC],Glycoside Hydrolases [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "84165-102-53",
"PackageDescription": "53 BAG in 1 BOX (84165-102-53) / 12 g in 1 BAG (84165-102-01) ",
"NDC11Code": "84165-0102-53",
"ProductNDC": "84165-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chinese Red Tiger Lidocaine Patches",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240829",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": ".04",
"StrengthUnit": "g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240829",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows."
},
{
"NDCCode": "42708-102-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42708-102-30) ",
"NDC11Code": "42708-0102-30",
"ProductNDC": "42708-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrocloride",
"NonProprietaryName": "Meclizine Hydrocloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100604",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040659",
"LabelerName": "QPharma Inc",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191018",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "Y",
"IndicationAndUsage": "Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.",
"Description": "Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets. Meclizine hydrochloride tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Also, meclizine hydrochloride tablets USP, 12.5 mg contains FD&C blue #1 aluminum lake (11-13%) and meclizine hydrochloride tablets USP, 25 mg contains D&C yellow #10 aluminum lake (15 to 20%). Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base."
},
{
"NDCCode": "43485-102-03",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (43485-102-03) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-102-01) ",
"NDC11Code": "43485-0102-03",
"ProductNDC": "43485-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spritam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207958",
"LabelerName": "Aprecia Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). SPRITAM is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg and 500 mg round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). SPRITAM tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
},
{
"NDCCode": "43485-102-60",
"PackageDescription": "60 BLISTER PACK in 1 CARTON (43485-102-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-102-01) ",
"NDC11Code": "43485-0102-60",
"ProductNDC": "43485-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spritam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207958",
"LabelerName": "Aprecia Pharmaceuticals, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160205",
"SamplePackage": "N",
"IndicationAndUsage": "SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). SPRITAM is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg and 500 mg round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). SPRITAM tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed."
},
{
"NDCCode": "50090-4364-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-4364-0) ",
"NDC11Code": "50090-4364-00",
"ProductNDC": "50090-4364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190617",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only)."
},
{
"NDCCode": "50090-5029-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5029-0) ",
"NDC11Code": "50090-5029-00",
"ProductNDC": "50090-5029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200428",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171)."
},
{
"NDCCode": "50090-5033-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5033-0) ",
"NDC11Code": "50090-5033-00",
"ProductNDC": "50090-5033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only)."
},
{
"NDCCode": "50090-5033-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5033-1) ",
"NDC11Code": "50090-5033-01",
"ProductNDC": "50090-5033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200505",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only)."
},
{
"NDCCode": "50090-5034-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5034-0) ",
"NDC11Code": "50090-5034-00",
"ProductNDC": "50090-5034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200504",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only)."
},
{
"NDCCode": "50090-5034-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5034-1) ",
"NDC11Code": "50090-5034-01",
"ProductNDC": "50090-5034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200505",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only)."
},
{
"NDCCode": "50458-140-01",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (50458-140-01) ",
"NDC11Code": "50458-0140-01",
"ProductNDC": "50458-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130329",
"SamplePackage": "Y",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171)."
},
{
"NDCCode": "50458-140-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (50458-140-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50458-0140-10",
"ProductNDC": "50458-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130329",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171)."
},
{
"NDCCode": "50458-140-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50458-140-30) ",
"NDC11Code": "50458-0140-30",
"ProductNDC": "50458-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130329",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171)."
},
{
"NDCCode": "50458-140-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (50458-140-50) ",
"NDC11Code": "50458-0140-50",
"ProductNDC": "50458-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
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"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
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"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171)."
},
{
"NDCCode": "50458-140-90",
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"ProductNDC": "50458-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Janssen Pharmaceuticals, Inc.",
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"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171)."
},
{
"NDCCode": "50458-141-01",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (50458-141-01) ",
"NDC11Code": "50458-0141-01",
"ProductNDC": "50458-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN",
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"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171)."
},
{
"NDCCode": "50458-141-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (50458-141-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50458-0141-10",
"ProductNDC": "50458-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokana",
"NonProprietaryName": "Canagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204042",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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": "INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171)."
}
]
}
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<NDC>
<NDCCode>53247-102-53</NDCCode>
<PackageDescription>24 g in 1 TUBE (53247-102-53) </PackageDescription>
<NDC11Code>53247-0102-53</NDC11Code>
<ProductNDC>53247-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Security</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
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<PackageDescription>4.25 g in 1 PACKET (53247-102-51) </PackageDescription>
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<ProductNDC>53247-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<SamplePackage>N</SamplePackage>
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<NDCCode>53247-102-54</NDCCode>
<PackageDescription>43 g in 1 TUBE (53247-102-54) </PackageDescription>
<NDC11Code>53247-0102-54</NDC11Code>
<ProductNDC>53247-102</ProductNDC>
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<SubstanceName>SODIUM FLUORIDE</SubstanceName>
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<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>53247-102-55</NDCCode>
<PackageDescription>130 g in 1 TUBE (53247-102-55) </PackageDescription>
<NDC11Code>53247-0102-55</NDC11Code>
<ProductNDC>53247-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Maximum Security</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Bob Barker Company Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
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<NDC>
<NDCCode>25000-102-53</NDCCode>
<PackageDescription>4 BAG in 1 BOX (25000-102-53) / 1500 TABLET, EXTENDED RELEASE in 1 BAG</PackageDescription>
<NDC11Code>25000-0102-53</NDC11Code>
<ProductNDC>25000-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090295</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Extended-Release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride.The chemical name of Metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-Release Tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets, 500 mg or 750 mg contains the inactive ingredients colloidal silicon dioxide, hypromellose and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>37205-102-53</NDCCode>
<PackageDescription>12 SUPPOSITORY in 1 CARTON (37205-102-53)</PackageDescription>
<NDC11Code>37205-0102-53</NDC11Code>
<ProductNDC>37205-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>19970910</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>CARDINAL HEALTH, INC.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1 hour.</IndicationAndUsage>
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<NDC>
<NDCCode>43353-102-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (43353-102-53) </PackageDescription>
<NDC11Code>43353-0102-53</NDC11Code>
<ProductNDC>43353-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203374</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol tablets, USP are available as 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in Carisoprodol tablets USP, 350 mg include microcrystalline cellulose, lactose monohydrate, pregelatinized starch (botanical source: maize), croscarmellose sodium, povidone, silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>52807-102-53</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (52807-102-53) </PackageDescription>
<NDC11Code>52807-0102-53</NDC11Code>
<ProductNDC>52807-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200320</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangdong Longtai Industry Co.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skinre commended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57353-102-63</NDCCode>
<PackageDescription>2 BOX in 1 BOX (57353-102-63) > 1 TUBE in 1 BOX (57353-102-53) > 74 g in 1 TUBE (57353-102-13)</PackageDescription>
<NDC11Code>57353-0102-63</NDC11Code>
<ProductNDC>57353-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Power White 7</ProprietaryName>
<ProprietaryNameSuffix>Everyday Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20121201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>DENTOVATIONS INC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.24</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>69219-102-53</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 BOX (69219-102-53) / 300 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>69219-0102-53</NDC11Code>
<ProductNDC>69219-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eclipse Spf 50</ProprietaryName>
<ProprietaryNameSuffix>All Shades</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SCIENCE OF SKINCARE LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>5.2; 1.1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps hydrate and prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71112-102-53</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (71112-102-53) > 90 mg in 1 TUBE (71112-102-13) </PackageDescription>
<NDC11Code>71112-0102-53</NDC11Code>
<ProductNDC>71112-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Black Is White</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20170129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CURADEN AG</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.095</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-102-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-102-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0102-53</NDC11Code>
<ProductNDC>73069-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-mesenchyme</ProprietaryName>
<NonProprietaryName>Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; PRASTERONE; MALIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); FUCUS VESICULOSUS; HISTIDINE; HYALURONIDASE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); LACTIC ACID; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SUS SCROFA MESENCHYME; NADIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; PHENYLALANINE; PROLACTIN; RANCID BEEF; THUJA OCCIDENTALIS LEAF; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 201; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Endoglycosidase [EPC],Glycoside Hydrolases [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84165-102-53</NDCCode>
<PackageDescription>53 BAG in 1 BOX (84165-102-53) / 12 g in 1 BAG (84165-102-01) </PackageDescription>
<NDC11Code>84165-0102-53</NDC11Code>
<ProductNDC>84165-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chinese Red Tiger Lidocaine Patches</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240829</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42708-102-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42708-102-30) </PackageDescription>
<NDC11Code>42708-0102-30</NDC11Code>
<ProductNDC>42708-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrocloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrocloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100604</StartMarketingDate>
<EndMarketingDate>20261031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040659</ApplicationNumber>
<LabelerName>QPharma Inc</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191018</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.</IndicationAndUsage>
<Description>Meclizine hydrochloride, USP a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula. Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Tablets. Meclizine hydrochloride tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Also, meclizine hydrochloride tablets USP, 12.5 mg contains FD&C blue #1 aluminum lake (11-13%) and meclizine hydrochloride tablets USP, 25 mg contains D&C yellow #10 aluminum lake (15 to 20%). Each meclizine hydrochloride 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base.</Description>
</NDC>
<NDC>
<NDCCode>43485-102-03</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (43485-102-03) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-102-01) </PackageDescription>
<NDC11Code>43485-0102-03</NDC11Code>
<ProductNDC>43485-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spritam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207958</ApplicationNumber>
<LabelerName>Aprecia Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). SPRITAM is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg and 500 mg round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). SPRITAM tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
</NDC>
<NDC>
<NDCCode>43485-102-60</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 CARTON (43485-102-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-102-01) </PackageDescription>
<NDC11Code>43485-0102-60</NDC11Code>
<ProductNDC>43485-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spritam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207958</ApplicationNumber>
<LabelerName>Aprecia Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (1.1). SPRITAM is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg and 500 mg round, white to off-white, spearmint-flavored tablets for oral suspension. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). SPRITAM tablets for oral suspension contain 250 mg and 500 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor. SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression. SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.</Description>
</NDC>
<NDC>
<NDCCode>50090-4364-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-4364-0) </PackageDescription>
<NDC11Code>50090-4364-00</NDC11Code>
<ProductNDC>50090-4364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invokana</ProprietaryName>
<NonProprietaryName>Canagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204042</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CANAGLIFLOZIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>50090-5029-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-5029-0) </PackageDescription>
<NDC11Code>50090-5029-00</NDC11Code>
<ProductNDC>50090-5029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invokana</ProprietaryName>
<NonProprietaryName>Canagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204042</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CANAGLIFLOZIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171).</Description>
</NDC>
<NDC>
<NDCCode>50090-5033-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-5033-0) </PackageDescription>
<NDC11Code>50090-5033-00</NDC11Code>
<ProductNDC>50090-5033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invokana</ProprietaryName>
<NonProprietaryName>Canagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204042</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CANAGLIFLOZIN</SubstanceName>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171).</Description>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2026-06-15</LastUpdate>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171).</Description>
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<IndicationAndUsage>INVOKANA (canagliflozin) is indicated: 1 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., 2 to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 3 to reduce the risk of 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>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is:. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively. Inactive ingredients of the core tablet are croscarmellose sodium (E468), hydroxypropyl cellulose (E463), lactose anhydrous, 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 excipients: iron oxide yellow (E172) (100 mg tablet only), macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), and titanium dioxide (E171).</Description>
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