{
"NDC": [
{
"NDCCode": "0245-0008-35",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (0245-0008-35) > 3.7 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "00245-0008-35",
"ProductNDC": "0245-0008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fortical",
"NonProprietaryName": "Calcitonin Salmon",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021406",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "CALCITONIN SALMON",
"StrengthNumber": "2200",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Calcitonin [CS],Calcitonin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0245-0221-35",
"PackageDescription": "35 TABLET in 1 BLISTER PACK (0245-0221-35)",
"NDC11Code": "00245-0221-35",
"ProductNDC": "0245-0221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078310",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-16"
},
{
"NDCCode": "0245-0871-35",
"PackageDescription": "30 PACKET in 1 CARTON (0245-0871-35) / 5 g in 1 PACKET (0245-0871-89) ",
"NDC11Code": "00245-0871-35",
"ProductNDC": "0245-0871",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vogelxo",
"NonProprietaryName": "Testosterone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140609",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204399",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/5g",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140609",
"SamplePackage": "N",
"IndicationAndUsage": "Vogelxo is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.",
"Description": "Vogelxo (testosterone) gel, for topical use is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Vogelxo provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. Vogelxo is available in unit-dose tubes, unit-dose packets, and a metered-dose pump. One 5-g or two 5-g tubes/packets of Vogelxo contains 50 mg or 100 mg of testosterone, respectively. One pump actuation dispenses 1.25 g of gel, which contains 12.5 mg of testosterone. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. Each metered-dose pump container is capable of dispensing 60 pump actuations. The active pharmacological ingredient in Vogelxo is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure. Inactive ingredients in Vogelxo are carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine."
},
{
"NDCCode": "65862-245-35",
"PackageDescription": "3500 TABLET, FILM COATED in 1 BAG (65862-245-35) ",
"NDC11Code": "65862-0245-35",
"ProductNDC": "65862-245",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-12-21",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "15-JAN-09"
},
{
"NDCCode": "12828-0008-6",
"PackageDescription": "35 kg in 1 DRUM (12828-0008-6) ",
"NDC11Code": "12828-0008-06",
"ProductNDC": "12828-0008",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19860121",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Cambrex Profarmaco Milano Srl",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-02-10",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "21-JAN-86"
},
{
"NDCCode": "48102-008-35",
"PackageDescription": "1 TUBE in 1 CARTON (48102-008-35) > 3.5 g in 1 TUBE",
"NDC11Code": "48102-0008-35",
"ProductNDC": "48102-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20100118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062447",
"LabelerName": "Fera Pharmaceuticals",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "52696-0008-1",
"PackageDescription": "35 kg in 1 DRUM (52696-0008-1)",
"NDC11Code": "52696-0008-01",
"ProductNDC": "52696-0008",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Emtricitabine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20071023",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Evonik Operations GmbH",
"SubstanceName": "EMTRICITABINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "59148-008-35",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (59148-008-35) ",
"NDC11Code": "59148-0008-35",
"ProductNDC": "59148-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "60611-0008-1",
"PackageDescription": "35 mL in 1 BOTTLE, PUMP (60611-0008-1)",
"NDC11Code": "60611-0008-01",
"ProductNDC": "60611-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Abalone Crystaldouble Ex Cc",
"NonProprietaryName": "Niacinamide, Adenosine, Titanium Dioxide, Ethylhexyl Methoxycinnamate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170310",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "C&BCOSMETIC Co.,Ltd.",
"SubstanceName": "NIACINAMIDE; TITANIUM DIOXIDE; ADENOSINE; OCTINOXATE",
"StrengthNumber": "2; 4.694; .04; 7",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Use after your daily skincare routine. Apply starting from larger surface using your fingertip, applying from the center and out, using less around the eyes and ridge of the nose. *Always close the cover after each use. This prevents nourishing and moisturizing agents from evaporationg."
},
{
"NDCCode": "73330-0008-1",
"PackageDescription": "35 mL in 1 BOTTLE, PLASTIC (73330-0008-1) ",
"NDC11Code": "73330-0008-01",
"ProductNDC": "73330-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Perfect Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200406",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "COSNINE, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200406",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin.For use when soap and water are not available."
},
{
"NDCCode": "73927-0008-1",
"PackageDescription": "35 g in 1 TUBE (73927-0008-1) ",
"NDC11Code": "73927-0008-01",
"ProductNDC": "73927-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nobaton 1% Alpha Hydroxy Acid Ampoule",
"NonProprietaryName": "Nobaton 1% Alpha Hydroxy Acid Ampoule Toothpaste",
"DosageFormName": "OINTMENT",
"RouteName": "DENTAL",
"StartMarketingDate": "20250421",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "BD TECHNOLOGY CO.,LTD",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE; OLAFLUR",
"StrengthNumber": ".0975; 1",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250421",
"SamplePackage": "N",
"IndicationAndUsage": "l% Alpha Hydroxy Acid Ampoule Toothpaste can deeply clean the mouth and teeth, and resist dental caries."
},
{
"NDCCode": "75186-008-35",
"PackageDescription": "2000 mL in 1 BOTTLE, PUMP (75186-008-35) ",
"NDC11Code": "75186-0008-35",
"ProductNDC": "75186-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pyurx",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201013",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Huizhou Duomei Daily Necessities Co.,Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201013",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "78126-008-35",
"PackageDescription": "1479 mL in 1 BOTTLE (78126-008-35) ",
"NDC11Code": "78126-0008-35",
"ProductNDC": "78126-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "GUANGZHOU RAINHOME PHARM&TECH CO., LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin. recommended for repeated use."
},
{
"NDCCode": "79479-008-35",
"PackageDescription": "350 mL in 1 BOTTLE (79479-008-35) ",
"NDC11Code": "79479-0008-35",
"ProductNDC": "79479-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "COMERCIALIZADORA Y MULTISERVICIOS CAMALDO S.A. DE C.V.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200716",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "80026-008-35",
"PackageDescription": "35 mL in 1 BOTTLE (80026-008-35) ",
"NDC11Code": "80026-0008-35",
"ProductNDC": "80026-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Champagne Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Reaction Retail, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".75",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help decrease bacteria on the skin."
},
{
"NDCCode": "80948-008-35",
"PackageDescription": "6 BOTTLE in 1 PACKAGE (80948-008-35) > 250 mL in 1 BOTTLE",
"NDC11Code": "80948-0008-35",
"ProductNDC": "80948-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Puroma Instant Foaming Hand Sanitizer Without Fragrance",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210310",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ZENITH MICRO CONTROL",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210310",
"SamplePackage": "N"
},
{
"NDCCode": "84128-008-35",
"PackageDescription": "10 BAG in 1 BOX (84128-008-35) / 1 APPLICATOR in 1 BAG / 35 mL in 1 APPLICATOR",
"NDC11Code": "84128-0008-35",
"ProductNDC": "84128-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swab Applicator Brushes 2% W/w Chlorhexidine Gluconate (chg) And 70% V/v Isopropyi Alcohol (ipa)",
"NonProprietaryName": "Chlorhexidine Gluconate, Isopropyi Alcohol",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260513",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "XINXIANG XINDA TECHNOLOGY CO.,LTD",
"SubstanceName": "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL",
"StrengthNumber": "20; .7",
"StrengthUnit": "mg/mL; mL/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260513",
"SamplePackage": "N",
"IndicationAndUsage": "for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection."
},
{
"NDCCode": "0245-0822-04",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (0245-0822-04) / 1 TABLET in 1 BLISTER PACK (0245-0822-89) ",
"NDC11Code": "00245-0822-04",
"ProductNDC": "0245-0822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251021",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0822-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0245-0822-30) ",
"NDC11Code": "00245-0822-30",
"ProductNDC": "0245-0822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240624",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0823-04",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (0245-0823-04) / 1 TABLET in 1 BLISTER PACK (0245-0823-89) ",
"NDC11Code": "00245-0823-04",
"ProductNDC": "0245-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251021",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0823-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0245-0823-30) ",
"NDC11Code": "00245-0823-30",
"ProductNDC": "0245-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240624",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0824-04",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (0245-0824-04) / 1 TABLET in 1 BLISTER PACK (0245-0824-89) ",
"NDC11Code": "00245-0824-04",
"ProductNDC": "0245-0824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251021",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0824-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0245-0824-30) ",
"NDC11Code": "00245-0824-30",
"ProductNDC": "0245-0824",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240624",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0825-04",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (0245-0825-04) / 1 TABLET in 1 BLISTER PACK (0245-0825-89) ",
"NDC11Code": "00245-0825-04",
"ProductNDC": "0245-0825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251021",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0825-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0245-0825-30) ",
"NDC11Code": "00245-0825-30",
"ProductNDC": "0245-0825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240624",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "51060-245-01",
"PackageDescription": "1 TUBE in 1 CARTON (51060-245-01) > 30 mL in 1 TUBE",
"NDC11Code": "51060-0245-01",
"ProductNDC": "51060-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bb Tinted Treatment Primer Broad Spectrum Spf 30 Sunscreen",
"ProprietaryNameSuffix": "Medium",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Tarte, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "45.5; 35",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "57687-245-50",
"PackageDescription": "35 LOZENGE in 1 CONTAINER (57687-245-50) ",
"NDC11Code": "57687-0245-50",
"ProductNDC": "57687-245",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bach Pastilles Orange And Elderflower",
"NonProprietaryName": "Helianthemum Nummularium Whole, Prunus Cerasifera Whole, Ornithogalum Umbellatum, Clematis Vitalba Whole, And Impatiens Glandulifera Whole",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20061120",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nelson Bach USA Limited",
"SubstanceName": "HELIANTHEMUM NUMMULARIUM WHOLE; PRUNUS CERASIFERA WHOLE; ORNITHOGALUM UMBELLATUM WHOLE; CLEMATIS VITALBA WHOLE; IMPATIENS GLANDULIFERA WHOLE",
"StrengthNumber": "5; 5; 5; 5; 5",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061120",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional stress."
},
{
"NDCCode": "58151-245-93",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-245-93) ",
"NDC11Code": "58151-0245-93",
"ProductNDC": "58151-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica Cr",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209501",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "82.5",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "LYRICA CR is indicated for the management of: 1 Neuropathic pain associated with diabetic peripheral neuropathy, 2 Postherpetic neuralgia.",
"Description": "LYRICA CR (pregabalin extended-release) tablets are for oral use and contain pregabalin. Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35. LYRICA CR extended-release tablets are administered orally and contain 82.5, 165, or 330 mg of pregabalin, along with carbomer, colorants, crospovidone, Kollidon SR (polyvinyl acetate, povidone, sodium lauryl sulphate, and silica), magnesium stearate, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, talc, and titanium dioxide as inactive ingredients."
},
{
"NDCCode": "72659-245-00",
"PackageDescription": "35 g in 1 BOTTLE, PLASTIC (72659-245-00) ",
"NDC11Code": "72659-0245-00",
"ProductNDC": "72659-245",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Arsenic Trioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180102",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Umicore Argentina S.A.",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-10-10",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "02-JAN-18"
},
{
"NDCCode": "76420-245-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-245-30) ",
"NDC11Code": "76420-0245-30",
"ProductNDC": "76420-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20111212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201384",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2022-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220725",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use.",
"Description": "Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol. Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0245-0008-35</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (0245-0008-35) > 3.7 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>00245-0008-35</NDC11Code>
<ProductNDC>0245-0008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fortical</ProprietaryName>
<NonProprietaryName>Calcitonin Salmon</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021406</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>CALCITONIN SALMON</SubstanceName>
<StrengthNumber>2200</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Calcitonin [CS],Calcitonin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0245-0221-35</NDCCode>
<PackageDescription>35 TABLET in 1 BLISTER PACK (0245-0221-35)</PackageDescription>
<NDC11Code>00245-0221-35</NDC11Code>
<ProductNDC>0245-0221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078310</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>0245-0871-35</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (0245-0871-35) / 5 g in 1 PACKET (0245-0871-89) </PackageDescription>
<NDC11Code>00245-0871-35</NDC11Code>
<ProductNDC>0245-0871</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vogelxo</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140609</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204399</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5g</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vogelxo is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.</IndicationAndUsage>
<Description>Vogelxo (testosterone) gel, for topical use is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Vogelxo provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. Vogelxo is available in unit-dose tubes, unit-dose packets, and a metered-dose pump. One 5-g or two 5-g tubes/packets of Vogelxo contains 50 mg or 100 mg of testosterone, respectively. One pump actuation dispenses 1.25 g of gel, which contains 12.5 mg of testosterone. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. Each metered-dose pump container is capable of dispensing 60 pump actuations. The active pharmacological ingredient in Vogelxo is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure. Inactive ingredients in Vogelxo are carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>65862-245-35</NDCCode>
<PackageDescription>3500 TABLET, FILM COATED in 1 BAG (65862-245-35) </PackageDescription>
<NDC11Code>65862-0245-35</NDC11Code>
<ProductNDC>65862-245</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-21</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-JAN-09</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>12828-0008-6</NDCCode>
<PackageDescription>35 kg in 1 DRUM (12828-0008-6) </PackageDescription>
<NDC11Code>12828-0008-06</NDC11Code>
<ProductNDC>12828-0008</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19860121</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Cambrex Profarmaco Milano Srl</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-02-10</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-JAN-86</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>48102-008-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (48102-008-35) > 3.5 g in 1 TUBE</PackageDescription>
<NDC11Code>48102-0008-35</NDC11Code>
<ProductNDC>48102-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20100118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062447</ApplicationNumber>
<LabelerName>Fera Pharmaceuticals</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>52696-0008-1</NDCCode>
<PackageDescription>35 kg in 1 DRUM (52696-0008-1)</PackageDescription>
<NDC11Code>52696-0008-01</NDC11Code>
<ProductNDC>52696-0008</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Emtricitabine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20071023</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Evonik Operations GmbH</LabelerName>
<SubstanceName>EMTRICITABINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59148-008-35</NDCCode>
<PackageDescription>100 TABLET in 1 BLISTER PACK (59148-008-35) </PackageDescription>
<NDC11Code>59148-0008-35</NDC11Code>
<ProductNDC>59148-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>60611-0008-1</NDCCode>
<PackageDescription>35 mL in 1 BOTTLE, PUMP (60611-0008-1)</PackageDescription>
<NDC11Code>60611-0008-01</NDC11Code>
<ProductNDC>60611-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Abalone Crystaldouble Ex Cc</ProprietaryName>
<NonProprietaryName>Niacinamide, Adenosine, Titanium Dioxide, Ethylhexyl Methoxycinnamate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170310</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>C&BCOSMETIC Co.,Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE; TITANIUM DIOXIDE; ADENOSINE; OCTINOXATE</SubstanceName>
<StrengthNumber>2; 4.694; .04; 7</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Use after your daily skincare routine. Apply starting from larger surface using your fingertip, applying from the center and out, using less around the eyes and ridge of the nose. *Always close the cover after each use. This prevents nourishing and moisturizing agents from evaporationg.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73330-0008-1</NDCCode>
<PackageDescription>35 mL in 1 BOTTLE, PLASTIC (73330-0008-1) </PackageDescription>
<NDC11Code>73330-0008-01</NDC11Code>
<ProductNDC>73330-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Perfect Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200406</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>COSNINE, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73927-0008-1</NDCCode>
<PackageDescription>35 g in 1 TUBE (73927-0008-1) </PackageDescription>
<NDC11Code>73927-0008-01</NDC11Code>
<ProductNDC>73927-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nobaton 1% Alpha Hydroxy Acid Ampoule</ProprietaryName>
<NonProprietaryName>Nobaton 1% Alpha Hydroxy Acid Ampoule Toothpaste</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20250421</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>BD TECHNOLOGY CO.,LTD</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE; OLAFLUR</SubstanceName>
<StrengthNumber>.0975; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>l% Alpha Hydroxy Acid Ampoule Toothpaste can deeply clean the mouth and teeth, and resist dental caries.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75186-008-35</NDCCode>
<PackageDescription>2000 mL in 1 BOTTLE, PUMP (75186-008-35) </PackageDescription>
<NDC11Code>75186-0008-35</NDC11Code>
<ProductNDC>75186-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pyurx</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201013</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Huizhou Duomei Daily Necessities Co.,Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78126-008-35</NDCCode>
<PackageDescription>1479 mL in 1 BOTTLE (78126-008-35) </PackageDescription>
<NDC11Code>78126-0008-35</NDC11Code>
<ProductNDC>78126-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>GUANGZHOU RAINHOME PHARM&TECH CO., LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79479-008-35</NDCCode>
<PackageDescription>350 mL in 1 BOTTLE (79479-008-35) </PackageDescription>
<NDC11Code>79479-0008-35</NDC11Code>
<ProductNDC>79479-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>COMERCIALIZADORA Y MULTISERVICIOS CAMALDO S.A. DE C.V.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80026-008-35</NDCCode>
<PackageDescription>35 mL in 1 BOTTLE (80026-008-35) </PackageDescription>
<NDC11Code>80026-0008-35</NDC11Code>
<ProductNDC>80026-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Champagne Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Reaction Retail, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80948-008-35</NDCCode>
<PackageDescription>6 BOTTLE in 1 PACKAGE (80948-008-35) > 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>80948-0008-35</NDC11Code>
<ProductNDC>80948-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Puroma Instant Foaming Hand Sanitizer Without Fragrance</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ZENITH MICRO CONTROL</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84128-008-35</NDCCode>
<PackageDescription>10 BAG in 1 BOX (84128-008-35) / 1 APPLICATOR in 1 BAG / 35 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>84128-0008-35</NDC11Code>
<ProductNDC>84128-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swab Applicator Brushes 2% W/w Chlorhexidine Gluconate (chg) And 70% V/v Isopropyi Alcohol (ipa)</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate, Isopropyi Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260513</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>XINXIANG XINDA TECHNOLOGY CO.,LTD</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>20; .7</StrengthNumber>
<StrengthUnit>mg/mL; mL/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0245-0822-04</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (0245-0822-04) / 1 TABLET in 1 BLISTER PACK (0245-0822-89) </PackageDescription>
<NDC11Code>00245-0822-04</NDC11Code>
<ProductNDC>0245-0822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0822-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0245-0822-30) </PackageDescription>
<NDC11Code>00245-0822-30</NDC11Code>
<ProductNDC>0245-0822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0823-04</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (0245-0823-04) / 1 TABLET in 1 BLISTER PACK (0245-0823-89) </PackageDescription>
<NDC11Code>00245-0823-04</NDC11Code>
<ProductNDC>0245-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0823-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0245-0823-30) </PackageDescription>
<NDC11Code>00245-0823-30</NDC11Code>
<ProductNDC>0245-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0824-04</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (0245-0824-04) / 1 TABLET in 1 BLISTER PACK (0245-0824-89) </PackageDescription>
<NDC11Code>00245-0824-04</NDC11Code>
<ProductNDC>0245-0824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0824-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0245-0824-30) </PackageDescription>
<NDC11Code>00245-0824-30</NDC11Code>
<ProductNDC>0245-0824</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0825-04</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (0245-0825-04) / 1 TABLET in 1 BLISTER PACK (0245-0825-89) </PackageDescription>
<NDC11Code>00245-0825-04</NDC11Code>
<ProductNDC>0245-0825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0825-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0245-0825-30) </PackageDescription>
<NDC11Code>00245-0825-30</NDC11Code>
<ProductNDC>0245-0825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>51060-245-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51060-245-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>51060-0245-01</NDC11Code>
<ProductNDC>51060-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bb Tinted Treatment Primer Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Medium</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Tarte, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>45.5; 35</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57687-245-50</NDCCode>
<PackageDescription>35 LOZENGE in 1 CONTAINER (57687-245-50) </PackageDescription>
<NDC11Code>57687-0245-50</NDC11Code>
<ProductNDC>57687-245</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bach Pastilles Orange And Elderflower</ProprietaryName>
<NonProprietaryName>Helianthemum Nummularium Whole, Prunus Cerasifera Whole, Ornithogalum Umbellatum, Clematis Vitalba Whole, And Impatiens Glandulifera Whole</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061120</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nelson Bach USA Limited</LabelerName>
<SubstanceName>HELIANTHEMUM NUMMULARIUM WHOLE; PRUNUS CERASIFERA WHOLE; ORNITHOGALUM UMBELLATUM WHOLE; CLEMATIS VITALBA WHOLE; IMPATIENS GLANDULIFERA WHOLE</SubstanceName>
<StrengthNumber>5; 5; 5; 5; 5</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional stress.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58151-245-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-245-93) </PackageDescription>
<NDC11Code>58151-0245-93</NDC11Code>
<ProductNDC>58151-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica Cr</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209501</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>82.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYRICA CR is indicated for the management of: 1 Neuropathic pain associated with diabetic peripheral neuropathy, 2 Postherpetic neuralgia.</IndicationAndUsage>
<Description>LYRICA CR (pregabalin extended-release) tablets are for oral use and contain pregabalin. Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35. LYRICA CR extended-release tablets are administered orally and contain 82.5, 165, or 330 mg of pregabalin, along with carbomer, colorants, crospovidone, Kollidon SR (polyvinyl acetate, povidone, sodium lauryl sulphate, and silica), magnesium stearate, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, talc, and titanium dioxide as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>72659-245-00</NDCCode>
<PackageDescription>35 g in 1 BOTTLE, PLASTIC (72659-245-00) </PackageDescription>
<NDC11Code>72659-0245-00</NDC11Code>
<ProductNDC>72659-245</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Arsenic Trioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180102</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Umicore Argentina S.A.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-10</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JAN-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>76420-245-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-245-30) </PackageDescription>
<NDC11Code>76420-0245-30</NDC11Code>
<ProductNDC>76420-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201384</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use.</IndicationAndUsage>
<Description>Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol. Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol.</Description>
</NDC>
</NDCList>