{
"NDC": [
{
"NDCCode": "63148-580-14",
"PackageDescription": "400 mL in 1 BOTTLE, PLASTIC (63148-580-14) ",
"NDC11Code": "63148-0580-14",
"ProductNDC": "63148-580",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Classic Clean",
"NonProprietaryName": "Shampoo",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230428",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Apollo Health and Beauty Care",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1000",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230428",
"SamplePackage": "N",
"IndicationAndUsage": "To help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "21695-580-14",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (21695-580-14)",
"NDC11Code": "21695-0580-14",
"ProductNDC": "21695-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19820422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087800",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Prednisone tablets and solutions are indicated in the following conditions.",
"Description": "Each tablet for oral administration contains. Prednisone.............................................................50 mg."
},
{
"NDCCode": "43419-580-14",
"PackageDescription": "5 mL in 1 TUBE (43419-580-14) ",
"NDC11Code": "43419-0580-14",
"ProductNDC": "43419-580",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amorepacific Natural Protector",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160118",
"EndMarketingDate": "20200530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1500; 5400; 2700; 5400",
"StrengthUnit": "mg/60mL; mg/60mL; mg/60mL; mg/60mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180801",
"EndMarketingDatePackage": "20200530",
"SamplePackage": "N"
},
{
"NDCCode": "59779-580-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-580-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "59779-0580-01",
"ProductNDC": "59779-580",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022032",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150331",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "59779-580-03",
"PackageDescription": "3 BOTTLE in 1 CARTON (59779-580-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "59779-0580-03",
"ProductNDC": "59779-580",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022032",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150327",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "63148-178-14",
"PackageDescription": "397 g in 1 JAR (63148-178-14) ",
"NDC11Code": "63148-0178-14",
"ProductNDC": "63148-178",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260430",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Apollo Health and Beauty Care",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "41",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps protect from wetness."
},
{
"NDCCode": "63148-330-14",
"PackageDescription": "396 g in 1 BOTTLE, PLASTIC (63148-330-14)",
"NDC11Code": "63148-0330-14",
"ProductNDC": "63148-330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrating Healing",
"ProprietaryNameSuffix": "Daily Thrapy",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100719",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "APOLLO HEALTH AND BEAUTY CARE",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "41",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63148-410-14",
"PackageDescription": "399 mL in 1 BOTTLE, PLASTIC (63148-410-14)",
"NDC11Code": "63148-0410-14",
"ProductNDC": "63148-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "P.o.v. 2 In 1 Dry Scalp Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Apollo Health and Beauty Care Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "to help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "63148-411-14",
"PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (63148-411-14)",
"NDC11Code": "63148-0411-14",
"ProductNDC": "63148-411",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "P.o.v. Classic Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Apollo Health and Beauty Care Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "to help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "63148-413-14",
"PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (63148-413-14)",
"NDC11Code": "63148-0413-14",
"ProductNDC": "63148-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Classic Control Antidandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170329",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Apollo Health and Beauty Care Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "to help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "63148-415-14",
"PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (63148-415-14)",
"NDC11Code": "63148-0415-14",
"ProductNDC": "63148-415",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "2 In 1 Antidandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170329",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Apollo Health and Beauty Care Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "To help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "63148-418-14",
"PackageDescription": "400 mL in 1 BOTTLE, PLASTIC (63148-418-14)",
"NDC11Code": "63148-0418-14",
"ProductNDC": "63148-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dandruff Shampoo And Conditioner",
"ProprietaryNameSuffix": "With Cucumber And Lemongrass Extracts",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100308",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358",
"LabelerName": "APOLLO HEALTH AND BEAUTY CARE",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63148-431-14",
"PackageDescription": "399 mL in 1 BOTTLE, PLASTIC (63148-431-14)",
"NDC11Code": "63148-0431-14",
"ProductNDC": "63148-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "P.o.v. Green Apple 2 In 1 Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Apollo Health and Beauty Care Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "to help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "63148-433-14",
"PackageDescription": "399 mL in 1 BOTTLE, PLASTIC (63148-433-14)",
"NDC11Code": "63148-0433-14",
"ProductNDC": "63148-433",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "P.o.v. Timeless Spice 2 In 1 Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171124",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Apollo Health and Beauty Care Inc.",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"IndicationAndUsage": "to help prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "63148-434-14",
"PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (63148-434-14)",
"NDC11Code": "63148-0434-14",
"ProductNDC": "63148-434",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alberto Vo5 2 In 1 Dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160118",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "APOLLO HEALTH AND BEAUTY CARE",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "63148-562-14",
"PackageDescription": "414 mL in 1 BOTTLE, PLASTIC (63148-562-14) ",
"NDC11Code": "63148-0562-14",
"ProductNDC": "63148-562",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "P.o.v Itch Relief Body",
"NonProprietaryName": "Dimethicone, Menthol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180328",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Apollo Health and Beauty Care Inc.",
"SubstanceName": "DIMETHICONE; MENTHOL",
"StrengthNumber": "50; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180328",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily protects and helps relieve chapped or cracked skin. temporarily relieves itching associated with: minor skin irritations, minor burns, rashes due to poison ivy, oak and sumac. insect bites. sunburn."
},
{
"NDCCode": "63148-316-50",
"PackageDescription": "1470 mL in 1 BOTTLE, PLASTIC (63148-316-50) ",
"NDC11Code": "63148-0316-50",
"ProductNDC": "63148-316",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hy-vee Lhs",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Apollo Health and Beauty Care",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "130",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"IndicationAndUsage": "helps eliminate bacterial on hands."
},
{
"NDCCode": "43598-580-30",
"PackageDescription": "30 POUCH in 1 CARTON (43598-580-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-580-01) ",
"NDC11Code": "43598-0580-30",
"ProductNDC": "43598-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine And Naloxone",
"NonProprietaryName": "Buprenorphine And Naloxone",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20180614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205806",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE",
"StrengthNumber": "4; 1",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180614",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "Buprenorphine and naloxone sublingual film,, 4 mg/1 mg or 12 mg/3 mg are orange rectangular films, imprinted with \"4\" or \"12\" in blue ink as a strength identifier (\"4\" or \"12\" may appear to be green in color). It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available as 4 mg buprenorphine with 1 mg naloxone, and 12 mg buprenorphine with 3 mg naloxone. Each film also contains acesulfame potassium salt, ammonium hydroxide, anhydrous citric acid, butylated hydroxyanisole, butylated hydroxytoluene, FD&C Blue No. 1, FD&C Yellow #6, lemon-lime flavor, maltitol, polyethylene oxide, povidone, shellac, and sodium phosphate dibasic anhydrous. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl is a white or almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-allyl-4,5 α -epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate is a white or almost white powder and is soluble in water, slightly soluble in alcohol, and practically insoluble in toluene and ether."
},
{
"NDCCode": "45802-580-01",
"PackageDescription": "1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01) ",
"NDC11Code": "45802-0580-01",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170613",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-580-46",
"PackageDescription": "10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-46",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170613",
"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170613",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
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"PackageDescription": "24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-62",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
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"EndMarketingDate": "20280630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "45802-580-84",
"PackageDescription": "4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "45802-0580-84",
"ProductNDC": "45802-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine Transdermal System",
"NonProprietaryName": "Scopolamine Transdermal System",
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"EndMarketingDate": "20280630",
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"ApplicationNumber": "ANDA078830",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "47335-984-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (47335-984-64) / 10 CAPSULE in 1 BLISTER PACK (47335-984-60) ",
"NDC11Code": "47335-0984-64",
"ProductNDC": "47335-984",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezallor Sprinkle",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208647",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190504",
"SamplePackage": "N",
"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
"NDCCode": "47335-984-81",
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"NDC11Code": "47335-0984-81",
"ProductNDC": "47335-984",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208647",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
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"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
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"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
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"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
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"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
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<NDC11Code>63148-0431-14</NDC11Code>
<ProductNDC>63148-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>P.o.v. Green Apple 2 In 1 Dandruff</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Apollo Health and Beauty Care Inc.</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>to help prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63148-433-14</NDCCode>
<PackageDescription>399 mL in 1 BOTTLE, PLASTIC (63148-433-14)</PackageDescription>
<NDC11Code>63148-0433-14</NDC11Code>
<ProductNDC>63148-433</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>P.o.v. Timeless Spice 2 In 1 Dandruff</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Apollo Health and Beauty Care Inc.</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<IndicationAndUsage>to help prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63148-434-14</NDCCode>
<PackageDescription>420 mL in 1 BOTTLE, PLASTIC (63148-434-14)</PackageDescription>
<NDC11Code>63148-0434-14</NDC11Code>
<ProductNDC>63148-434</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alberto Vo5 2 In 1 Dandruff</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>APOLLO HEALTH AND BEAUTY CARE</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63148-562-14</NDCCode>
<PackageDescription>414 mL in 1 BOTTLE, PLASTIC (63148-562-14) </PackageDescription>
<NDC11Code>63148-0562-14</NDC11Code>
<ProductNDC>63148-562</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>P.o.v Itch Relief Body</ProprietaryName>
<NonProprietaryName>Dimethicone, Menthol</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180328</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Apollo Health and Beauty Care Inc.</LabelerName>
<SubstanceName>DIMETHICONE; MENTHOL</SubstanceName>
<StrengthNumber>50; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily protects and helps relieve chapped or cracked skin. temporarily relieves itching associated with: minor skin irritations, minor burns, rashes due to poison ivy, oak and sumac. insect bites. sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63148-316-50</NDCCode>
<PackageDescription>1470 mL in 1 BOTTLE, PLASTIC (63148-316-50) </PackageDescription>
<NDC11Code>63148-0316-50</NDC11Code>
<ProductNDC>63148-316</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hy-vee Lhs</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Apollo Health and Beauty Care</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps eliminate bacterial on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-580-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (43598-580-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-580-01) </PackageDescription>
<NDC11Code>43598-0580-30</NDC11Code>
<ProductNDC>43598-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine And Naloxone</ProprietaryName>
<NonProprietaryName>Buprenorphine And Naloxone</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20180614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205806</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE</SubstanceName>
<StrengthNumber>4; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine and naloxone sublingual film,, 4 mg/1 mg or 12 mg/3 mg are orange rectangular films, imprinted with "4" or "12" in blue ink as a strength identifier ("4" or "12" may appear to be green in color). It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available as 4 mg buprenorphine with 1 mg naloxone, and 12 mg buprenorphine with 3 mg naloxone. Each film also contains acesulfame potassium salt, ammonium hydroxide, anhydrous citric acid, butylated hydroxyanisole, butylated hydroxytoluene, FD&C Blue No. 1, FD&C Yellow #6, lemon-lime flavor, maltitol, polyethylene oxide, povidone, shellac, and sodium phosphate dibasic anhydrous. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl is a white or almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-allyl-4,5 α -epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate is a white or almost white powder and is soluble in water, slightly soluble in alcohol, and practically insoluble in toluene and ether.</Description>
</NDC>
<NDC>
<NDCCode>45802-580-01</NDCCode>
<PackageDescription>1 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01) </PackageDescription>
<NDC11Code>45802-0580-01</NDC11Code>
<ProductNDC>45802-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine Transdermal System</ProprietaryName>
<NonProprietaryName>Scopolamine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078830</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>45802-580-46</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH</PackageDescription>
<NDC11Code>45802-0580-46</NDC11Code>
<ProductNDC>45802-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine Transdermal System</ProprietaryName>
<NonProprietaryName>Scopolamine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<EndMarketingDate>20280630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078830</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>45802-580-62</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH</PackageDescription>
<NDC11Code>45802-0580-62</NDC11Code>
<ProductNDC>45802-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine Transdermal System</ProprietaryName>
<NonProprietaryName>Scopolamine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<EndMarketingDate>20280630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078830</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>45802-580-84</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH</PackageDescription>
<NDC11Code>45802-0580-84</NDC11Code>
<ProductNDC>45802-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine Transdermal System</ProprietaryName>
<NonProprietaryName>Scopolamine Transdermal System</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170613</StartMarketingDate>
<EndMarketingDate>20280630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078830</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170613</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is:. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>47335-984-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (47335-984-64) / 10 CAPSULE in 1 BLISTER PACK (47335-984-60) </PackageDescription>
<NDC11Code>47335-0984-64</NDC11Code>
<ProductNDC>47335-984</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezallor Sprinkle</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208647</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>47335-984-81</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (47335-984-81) </PackageDescription>
<NDC11Code>47335-0984-81</NDC11Code>
<ProductNDC>47335-984</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezallor Sprinkle</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208647</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
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<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
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<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
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<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
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<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
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<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
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<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
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