{
"NDC": [
{
"NDCCode": "90087-5370-2",
"PackageDescription": "10000 mL in 1 BOTTLE, PUMP (90087-5370-2) ",
"NDC11Code": "90087-5370-02",
"ProductNDC": "90087-5370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eesome Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Eesome",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "90087-5370-1",
"PackageDescription": "10000 mL in 1 BOTTLE, PUMP (90087-5370-1) ",
"NDC11Code": "90087-5370-01",
"ProductNDC": "90087-5370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eesome Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Eesome",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "90087-5370-3",
"PackageDescription": "10000 mL in 1 BOTTLE, PUMP (90087-5370-3) ",
"NDC11Code": "90087-5370-03",
"ProductNDC": "90087-5370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eesome Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Eesome",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0006-5370-03",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0006-5370-03) ",
"NDC11Code": "00006-5370-03",
"ProductNDC": "0006-5370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Segluromet",
"NonProprietaryName": "Ertugliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209806",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "SEGLUROMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class."
},
{
"NDCCode": "0006-5370-06",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (0006-5370-06) ",
"NDC11Code": "00006-5370-06",
"ProductNDC": "0006-5370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Segluromet",
"NonProprietaryName": "Ertugliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209806",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "SEGLUROMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class."
},
{
"NDCCode": "0006-5370-07",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0006-5370-07) ",
"NDC11Code": "00006-5370-07",
"ProductNDC": "0006-5370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Segluromet",
"NonProprietaryName": "Ertugliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209806",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "SEGLUROMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class."
},
{
"NDCCode": "12578-119-99",
"PackageDescription": "5370 SOLUTION in 1 DRUM (12578-119-99) ",
"NDC11Code": "12578-0119-99",
"ProductNDC": "12578-119",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Polyethylene Glycol 400",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20220501",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Janssen Pharmaceutica NV",
"SubstanceName": "POLYETHYLENE GLYCOL 400",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-10-08",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-MAY-22"
},
{
"NDCCode": "51672-5305-2",
"PackageDescription": "1 TUBE in 1 CARTON (51672-5305-2) > 30 g in 1 TUBE",
"NDC11Code": "51672-5305-02",
"ProductNDC": "51672-5305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pliaglis",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181211",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021717",
"LabelerName": "Taro Pharmaceuticals U.S.A., Inc.",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181211",
"SamplePackage": "N",
"IndicationAndUsage": "PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "53002-5370-3",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5370-3) ",
"NDC11Code": "53002-5370-03",
"ProductNDC": "53002-5370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075185",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac is indicated: : 1 For relief of the signs and symptoms of osteoarthritis , 2 For relief of the signs and symptoms of rheumatoid arthritis , 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis .",
"Description": "Diclofenac sodium delayed-release tablets is a benzene-acetic acid derivative. Diclofenac sodium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "0781-5370-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5370-01)",
"NDC11Code": "00781-5370-01",
"ProductNDC": "0781-5370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvastatin Sodium",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Fluvastatin Sodium",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151016",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021192",
"LabelerName": "Sandoz Inc",
"SubstanceName": "FLUVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0781-5370-31",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5370-31)",
"NDC11Code": "00781-5370-31",
"ProductNDC": "0781-5370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvastatin Sodium",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Fluvastatin Sodium",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151016",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021192",
"LabelerName": "Sandoz Inc",
"SubstanceName": "FLUVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-5370-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-5370-0) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-5370-00",
"ProductNDC": "55154-5370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120210",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076056",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120210",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: oPrimary dysbetalipoproteinemia.oHypertriglyceridemia.",
"Description": "Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C 23H 35NaO 7M.W. 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No.10."
},
{
"NDCCode": "62670-5370-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-5370-0) ",
"NDC11Code": "62670-5370-00",
"ProductNDC": "62670-5370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Resting Grinch Face",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171204",
"EndMarketingDate": "20180604",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171204",
"EndMarketingDatePackage": "20180604",
"SamplePackage": "N"
},
{
"NDCCode": "62670-5370-1",
"PackageDescription": "73 mL in 1 BOTTLE (62670-5370-1) ",
"NDC11Code": "62670-5370-01",
"ProductNDC": "62670-5370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Resting Grinch Face",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171204",
"EndMarketingDate": "20180604",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171204",
"EndMarketingDatePackage": "20180604",
"SamplePackage": "N"
},
{
"NDCCode": "62670-5370-3",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (62670-5370-3) ",
"NDC11Code": "62670-5370-03",
"ProductNDC": "62670-5370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Resting Grinch Face",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171204",
"EndMarketingDate": "20180604",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171204",
"EndMarketingDatePackage": "20180604",
"SamplePackage": "N"
},
{
"NDCCode": "70694-5370-6",
"PackageDescription": "30 mL in 1 BOTTLE (70694-5370-6) ",
"NDC11Code": "70694-5370-06",
"ProductNDC": "70694-5370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi Hydro Dp B Tox Ampoule",
"NonProprietaryName": "Niacinamide,adenosine",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170808",
"EndMarketingDate": "20180808",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "MBG Inc (Korea Institute of Science Development)",
"SubstanceName": "NIACINAMIDE; ADENOSINE",
"StrengthNumber": ".02; .004",
"StrengthUnit": "mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "71085-100-30",
"PackageDescription": "1 TUBE in 1 CARTON (71085-100-30) / 30 g in 1 TUBE",
"NDC11Code": "71085-0100-30",
"ProductNDC": "71085-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pliaglis",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260306",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021717",
"LabelerName": "IPG PHARMACEUTICALS, INC.",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260306",
"SamplePackage": "N",
"IndicationAndUsage": "PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol: water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "71800-631-04",
"PackageDescription": "4 TUBE in 1 CARTON (71800-631-04) > 30 g in 1 TUBE",
"NDC11Code": "71800-0631-04",
"ProductNDC": "71800-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Tetracaine",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170503",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021717",
"LabelerName": "Innovida Pharmaceutique Corporation",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180418",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and tetracaine cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "Lidocaine and tetracaine cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C 14H 22N 2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C 15H 24N 2O 2. The structural formula is:. Each gram of lidocaine and tetracaine cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "71800-631-08",
"PackageDescription": "8 TUBE in 1 CARTON (71800-631-08) > 30 g in 1 TUBE",
"NDC11Code": "71800-0631-08",
"ProductNDC": "71800-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Tetracaine",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170503",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021717",
"LabelerName": "Innovida Pharmaceutique Corporation",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180418",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and tetracaine cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "Lidocaine and tetracaine cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C 14H 22N 2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C 15H 24N 2O 2. The structural formula is:. Each gram of lidocaine and tetracaine cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "73575-009-02",
"PackageDescription": "2 TUBE in 1 CARTON (73575-009-02) > 30 g in 1 TUBE",
"NDC11Code": "73575-0009-02",
"ProductNDC": "73575-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pliaglis",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021717",
"LabelerName": "Oba Pharmaceuticals, Inc.",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "73575-009-04",
"PackageDescription": "4 TUBE in 1 CARTON (73575-009-04) > 30 g in 1 TUBE",
"NDC11Code": "73575-0009-04",
"ProductNDC": "73575-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pliaglis",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021717",
"LabelerName": "Oba Pharmaceuticals, Inc.",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "73575-009-09",
"PackageDescription": "1 TUBE in 1 CARTON (73575-009-09) > 30 g in 1 TUBE",
"NDC11Code": "73575-0009-09",
"ProductNDC": "73575-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pliaglis",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021717",
"LabelerName": "Oba Pharmaceuticals, Inc.",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "73575-010-02",
"PackageDescription": "2 TUBE in 1 CARTON (73575-010-02) > 30 g in 1 TUBE",
"NDC11Code": "73575-0010-02",
"ProductNDC": "73575-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pliaglis",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021717",
"LabelerName": "Oba Pharmaceuticals, Inc.",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "73575-010-04",
"PackageDescription": "4 TUBE in 1 CARTON (73575-010-04) > 30 g in 1 TUBE",
"NDC11Code": "73575-0010-04",
"ProductNDC": "73575-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pliaglis",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021717",
"LabelerName": "Oba Pharmaceuticals, Inc.",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "73575-010-09",
"PackageDescription": "1 TUBE in 1 CARTON (73575-010-09) > 30 g in 1 TUBE",
"NDC11Code": "73575-0010-09",
"ProductNDC": "73575-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pliaglis",
"NonProprietaryName": "Lidocaine And Tetracaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200124",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021717",
"LabelerName": "Oba Pharmaceuticals, Inc.",
"SubstanceName": "LIDOCAINE; TETRACAINE",
"StrengthNumber": "70; 70",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200124",
"SamplePackage": "N",
"IndicationAndUsage": "PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.",
"Description": "PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum."
},
{
"NDCCode": "0002-0152-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-01) / .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-0152-01",
"ProductNDC": "0002-0152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zepbound",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217806",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240328",
"SamplePackage": "N",
"IndicationAndUsage": "ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .",
"Description": "ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming."
},
{
"NDCCode": "0002-0152-04",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-04) / .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-0152-04",
"ProductNDC": "0002-0152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zepbound",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217806",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240808",
"SamplePackage": "N",
"IndicationAndUsage": "ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .",
"Description": "ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming."
},
{
"NDCCode": "0002-0152-61",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-61) / .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-0152-61",
"ProductNDC": "0002-0152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zepbound",
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"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217806",
"LabelerName": "Eli Lilly and Company",
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"IndicationAndUsage": "ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .",
"Description": "ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming."
},
{
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"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0002-0213-01) / 3 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-0213-01",
"ProductNDC": "0002-0213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin",
"ProprietaryNameSuffix": "R",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PARENTERAL",
"StartMarketingDate": "19830627",
"EndMarketingDate": "20261215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA018780",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-08",
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"SamplePackage": "N",
"IndicationAndUsage": "HUMULIN R is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN R (insulin human) injection is a short-acting human insulin for subcutaneous or intravenous use. HUMULIN R is a sterile, aqueous, clear, and colorless solution. HUMULIN R contains 100 units of insulin human in each milliliter. Each milliliter of HUMULIN R also contains glycerin (16 mg), metacresol (2.5 mg), endogenous zinc (approximately 0.015 mg/100 units,) and Water for Injection. Sodium hydroxide and hydrochloric acid may be added during manufacture to adjust the pH. The pH is 7.0 to 7.8."
},
{
"NDCCode": "0002-0243-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0243-01) / .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-0243-01",
"ProductNDC": "0002-0243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zepbound",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
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"MarketingCategoryName": "NDA",
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"LabelerName": "Eli Lilly and Company",
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"Pharm_Classes": "G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]",
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"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .",
"Description": "ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming."
}
]
}
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<NDC>
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<NDC11Code>00006-5370-03</NDC11Code>
<ProductNDC>0006-5370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Segluromet</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
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<LastUpdate>2026-08-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<Description>SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class.</Description>
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<NDC>
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<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (0006-5370-06) </PackageDescription>
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<ProductNDC>0006-5370</ProductNDC>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0006-5370-07) </PackageDescription>
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<ProductNDC>0006-5370</ProductNDC>
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<LastUpdate>2026-08-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>5370 SOLUTION in 1 DRUM (12578-119-99) </PackageDescription>
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<ProductNDC>12578-119</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Polyethylene Glycol 400</NonProprietaryName>
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<StartMarketingDate>20220501</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
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<SubstanceName>POLYETHYLENE GLYCOL 400</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-08</LastUpdate>
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<StartMarketingDatePackage>01-MAY-22</StartMarketingDatePackage>
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<NDC>
<NDCCode>51672-5305-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-5305-2) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-5305-02</NDC11Code>
<ProductNDC>51672-5305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pliaglis</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181211</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Taro Pharmaceuticals U.S.A., Inc.</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
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<NDC>
<NDCCode>53002-5370-3</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5370-3) </PackageDescription>
<NDC11Code>53002-5370-03</NDC11Code>
<ProductNDC>53002-5370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075185</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac is indicated: : 1 For relief of the signs and symptoms of osteoarthritis , 2 For relief of the signs and symptoms of rheumatoid arthritis , 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis .</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets is a benzene-acetic acid derivative. Diclofenac sodium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0781-5370-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5370-01)</PackageDescription>
<NDC11Code>00781-5370-01</NDC11Code>
<ProductNDC>0781-5370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvastatin Sodium</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Fluvastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151016</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021192</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>FLUVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0781-5370-31</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5370-31)</PackageDescription>
<NDC11Code>00781-5370-31</NDC11Code>
<ProductNDC>0781-5370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvastatin Sodium</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Fluvastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151016</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021192</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>FLUVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-5370-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-5370-0) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-5370-00</NDC11Code>
<ProductNDC>55154-5370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120210</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076056</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120210</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with: oPrimary dysbetalipoproteinemia.oHypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1 S- [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C 23H 35NaO 7M.W. 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No.10.</Description>
</NDC>
<NDC>
<NDCCode>62670-5370-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-5370-0) </PackageDescription>
<NDC11Code>62670-5370-00</NDC11Code>
<ProductNDC>62670-5370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Resting Grinch Face</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171204</StartMarketingDate>
<EndMarketingDate>20180604</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171204</StartMarketingDatePackage>
<EndMarketingDatePackage>20180604</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-5370-1</NDCCode>
<PackageDescription>73 mL in 1 BOTTLE (62670-5370-1) </PackageDescription>
<NDC11Code>62670-5370-01</NDC11Code>
<ProductNDC>62670-5370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Resting Grinch Face</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171204</StartMarketingDate>
<EndMarketingDate>20180604</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171204</StartMarketingDatePackage>
<EndMarketingDatePackage>20180604</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-5370-3</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (62670-5370-3) </PackageDescription>
<NDC11Code>62670-5370-03</NDC11Code>
<ProductNDC>62670-5370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Resting Grinch Face</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171204</StartMarketingDate>
<EndMarketingDate>20180604</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171204</StartMarketingDatePackage>
<EndMarketingDatePackage>20180604</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70694-5370-6</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (70694-5370-6) </PackageDescription>
<NDC11Code>70694-5370-06</NDC11Code>
<ProductNDC>70694-5370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi Hydro Dp B Tox Ampoule</ProprietaryName>
<NonProprietaryName>Niacinamide,adenosine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170808</StartMarketingDate>
<EndMarketingDate>20180808</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>MBG Inc (Korea Institute of Science Development)</LabelerName>
<SubstanceName>NIACINAMIDE; ADENOSINE</SubstanceName>
<StrengthNumber>.02; .004</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>71085-100-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (71085-100-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>71085-0100-30</NDC11Code>
<ProductNDC>71085-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pliaglis</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260306</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>IPG PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol: water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>71800-631-04</NDCCode>
<PackageDescription>4 TUBE in 1 CARTON (71800-631-04) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>71800-0631-04</NDC11Code>
<ProductNDC>71800-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Tetracaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170503</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Innovida Pharmaceutique Corporation</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and tetracaine cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>Lidocaine and tetracaine cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C 14H 22N 2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C 15H 24N 2O 2. The structural formula is:. Each gram of lidocaine and tetracaine cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>71800-631-08</NDCCode>
<PackageDescription>8 TUBE in 1 CARTON (71800-631-08) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>71800-0631-08</NDC11Code>
<ProductNDC>71800-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Tetracaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170503</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Innovida Pharmaceutique Corporation</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and tetracaine cream is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>Lidocaine and tetracaine cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C 14H 22N 2O. The structural formula is:. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C 15H 24N 2O 2. The structural formula is:. Each gram of lidocaine and tetracaine cream contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>73575-009-02</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (73575-009-02) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>73575-0009-02</NDC11Code>
<ProductNDC>73575-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pliaglis</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Oba Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>73575-009-04</NDCCode>
<PackageDescription>4 TUBE in 1 CARTON (73575-009-04) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>73575-0009-04</NDC11Code>
<ProductNDC>73575-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pliaglis</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Oba Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>73575-009-09</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (73575-009-09) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>73575-0009-09</NDC11Code>
<ProductNDC>73575-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pliaglis</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Oba Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>73575-010-02</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (73575-010-02) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>73575-0010-02</NDC11Code>
<ProductNDC>73575-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pliaglis</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Oba Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>73575-010-04</NDCCode>
<PackageDescription>4 TUBE in 1 CARTON (73575-010-04) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>73575-0010-04</NDC11Code>
<ProductNDC>73575-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pliaglis</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Oba Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>73575-010-09</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (73575-010-09) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>73575-0010-09</NDC11Code>
<ProductNDC>73575-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pliaglis</ProprietaryName>
<NonProprietaryName>Lidocaine And Tetracaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200124</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021717</ApplicationNumber>
<LabelerName>Oba Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LIDOCAINE; TETRACAINE</SubstanceName>
<StrengthNumber>70; 70</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.</IndicationAndUsage>
<Description>PLIAGLIS (lidocaine and tetracaine) Cream 7% / 7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The drug formulation is an emulsion in which the oil phase is a 1:1 eutectic mixture of lidocaine 7% and tetracaine 7%. The eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. The net weight of lidocaine is 2.1 g and of tetracaine is 2.1 g per 30 g tube. Lidocaine, an amide local anesthetic, is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl) and has an octanol:water partition ratio of 182 at pH 7.3. The molecular weight of lidocaine is 234.3, and the molecular formula is C14H22N2O. The structural formula is. Tetracaine, an ester local anesthetic, is chemically designated as 2-dimethylaminoethyl 4-n-butyl-aminobenzoate and has an octanol:water partition ratio of 5370 at pH 7.3. The molecular weight of tetracaine is 264.4, and the molecular formula is C15H24N2O2. The structural formula is. Each gram of PLIAGLIS contains lidocaine 70 mg and tetracaine 70 mg in a 1:1 eutectic mixture and it also contains the following inactive ingredients: anhydrous dibasic calcium phosphate, methylparaben, polyvinyl alcohol, propylparaben, purified water, sorbitan monopalmitate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0002-0152-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-01) / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-0152-01</NDC11Code>
<ProductNDC>0002-0152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zepbound</ProprietaryName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217806</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .</IndicationAndUsage>
<Description>ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
</NDC>
<NDC>
<NDCCode>0002-0152-04</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-04) / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-0152-04</NDC11Code>
<ProductNDC>0002-0152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zepbound</ProprietaryName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217806</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .</IndicationAndUsage>
<Description>ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
</NDC>
<NDC>
<NDCCode>0002-0152-61</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-61) / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-0152-61</NDC11Code>
<ProductNDC>0002-0152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zepbound</ProprietaryName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217806</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .</IndicationAndUsage>
<Description>ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
</NDC>
<NDC>
<NDCCode>0002-0213-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0002-0213-01) / 3 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-0213-01</NDC11Code>
<ProductNDC>0002-0213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin</ProprietaryName>
<ProprietaryNameSuffix>R</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PARENTERAL</RouteName>
<StartMarketingDate>19830627</StartMarketingDate>
<EndMarketingDate>20261215</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA018780</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230620</StartMarketingDatePackage>
<EndMarketingDatePackage>20261215</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMULIN R is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN R (insulin human) injection is a short-acting human insulin for subcutaneous or intravenous use. HUMULIN R is a sterile, aqueous, clear, and colorless solution. HUMULIN R contains 100 units of insulin human in each milliliter. Each milliliter of HUMULIN R also contains glycerin (16 mg), metacresol (2.5 mg), endogenous zinc (approximately 0.015 mg/100 units,) and Water for Injection. Sodium hydroxide and hydrochloric acid may be added during manufacture to adjust the pH. The pH is 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-0243-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0243-01) / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-0243-01</NDC11Code>
<ProductNDC>0002-0243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zepbound</ProprietaryName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217806</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity: : 1 to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. , 2 to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. .</IndicationAndUsage>
<Description>ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
</NDC>
</NDCList>