{
"NDC": [
{
"NDCCode": "68682-201-75",
"PackageDescription": "1 KIT in 1 CONTAINER (68682-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH",
"NDC11Code": "68682-0201-75",
"ProductNDC": "68682-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Peg-3350, Electrolytes, And Ascorbate",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, And Ascorbic Acid",
"DosageFormName": "KIT",
"StartMarketingDate": "20061001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021881",
"LabelerName": "Oceanside Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061001",
"SamplePackage": "N",
"IndicationAndUsage": "Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.",
"Description": "Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative consisting of 4 pouches (2 of Pouch A and 2 of Pouch B) containing white to yellow powder for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride, plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring containing citral, lime oil, maltodextrin, acacia gum, vitamin E, and other natural flavoring agents. Pouch A contains 111.9 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. Pouch B contains 10.6 g of powder for oral solution. When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an oral solution having a lemon taste. The entire, reconstituted, 2-liter Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution colon preparation contains 200 grams of polyethylene glycol-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 131 mg per treatment."
},
{
"NDCCode": "68682-272-75",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68682-272-75) / 7.5 g in 1 BOTTLE, PUMP",
"NDC11Code": "68682-0272-75",
"ProductNDC": "68682-272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imiquimod",
"NonProprietaryName": "Imiquimod",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022483",
"LabelerName": "Oceanside Pharmacueticals",
"SubstanceName": "IMIQUIMOD",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180627",
"SamplePackage": "N",
"IndicationAndUsage": "Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. ( 1.1) . Imiquimod Cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. ( 1.2) .",
"Description": "Imiquimod Cream, 3.75% is for topical administration. Each gram contains 37.5 mg of imiquimod, respectively, in a white to faintly yellow oil-in-water cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum. Chemically, imiquimod is 1-(2-methylpropyl)-1 H-imidazol[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C 14H 16N 4and a molecular weight of 240.3. Its structural formula is:."
},
{
"NDCCode": "68682-462-75",
"PackageDescription": "1 BOTTLE in 1 CARTON (68682-462-75) / 75 mL in 1 BOTTLE",
"NDC11Code": "68682-0462-75",
"ProductNDC": "68682-462",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate",
"NonProprietaryName": "Clindamycin Phosphate",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180608",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050782",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "CLINDAMYCIN PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180608",
"SamplePackage": "N",
"IndicationAndUsage": "In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, Clindamycin Phosphate Topical Gel applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table. There was a trend in the investigator’s global assessment of the results, which favored Clindamycin Phosphate Topical Gel QD over the vehicle QD. In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to Clindamycin Phosphate Topical Gel. There was no signal for contact sensitization in the clinical trials under normal use conditions.",
"Description": "Clindamycin Phosphate Topical Gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula represented below:. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate)."
},
{
"NDCCode": "11410-201-76",
"PackageDescription": "1 JAR in 1 BOX (11410-201-76) > 75 CLOTH in 1 JAR (11410-201-75)",
"NDC11Code": "11410-0201-76",
"ProductNDC": "11410-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Clear Zone Body Pads",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".036",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "43239-201-13",
"PackageDescription": "75 g in 1 TUBE (43239-201-13)",
"NDC11Code": "43239-0201-13",
"ProductNDC": "43239-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120710",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ERBAVIVA INC.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "HELPS PREVENT SUNBURN."
},
{
"NDCCode": "61126-201-75",
"PackageDescription": "75 mL in 1 BOTTLE (61126-201-75)",
"NDC11Code": "61126-0201-75",
"ProductNDC": "61126-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefzil",
"NonProprietaryName": "Cefprozil",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20161206",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050665",
"LabelerName": "Corden Pharma Latina S.p.A.",
"SubstanceName": "CEFPROZIL",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-02"
},
{
"NDCCode": "65649-201-75",
"PackageDescription": "1 KIT in 1 CONTAINER (65649-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH",
"NDC11Code": "65649-0201-75",
"ProductNDC": "65649-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moviprep",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate",
"DosageFormName": "KIT",
"StartMarketingDate": "20061001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021881",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061001",
"SamplePackage": "N",
"IndicationAndUsage": "MoviPrep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.",
"Description": "MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution) is an osmotic laxative consisting of 4 pouches (2 of Pouch A and 2 of Pouch B) containing white to yellow powder for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride, plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring containing citral, lime oil, maltodextrin, acacia gum, vitamin E, and other natural flavoring agents. Pouch A contains 111.9 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. Pouch B contains 10.6 g of powder for oral solution. When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) is an oral solution having a lemon taste. The entire, reconstituted, 2-liter MoviPrep colon preparation contains 200 grams of polyethylene glycol (PEG) 3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 131 mg per treatment."
},
{
"NDCCode": "66326-201-05",
"PackageDescription": "75 kg in 1 DRUM (66326-201-05) ",
"NDC11Code": "66326-0201-05",
"ProductNDC": "66326-201",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20191230",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Sri Krishna Pharmaceuticals Ltd. Unit I",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "900",
"StrengthUnit": "g/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "30-DEC-19"
},
{
"NDCCode": "68428-201-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-201-03) ",
"NDC11Code": "68428-0201-03",
"ProductNDC": "68428-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amygdalus Persica",
"NonProprietaryName": "Peach",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110126",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PRUNUS PERSICA FLOWER",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110126",
"SamplePackage": "N"
},
{
"NDCCode": "70626-201-51",
"PackageDescription": "1 TUBE in 1 BOX (70626-201-51) / 75 mL in 1 TUBE (70626-201-31) ",
"NDC11Code": "70626-0201-51",
"ProductNDC": "70626-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Picture Perfect Day Daily Moisturizer",
"NonProprietaryName": "Avobenzone, Octocrylene, Octisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160502",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ASPIRE BRANDS INC",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2; 3; 6",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160502",
"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": "73027-201-03",
"PackageDescription": "144 CELLO PACK in 1 CASE (73027-201-03) > 75 g in 1 CELLO PACK",
"NDC11Code": "73027-0201-03",
"ProductNDC": "73027-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bob Barker Antibacterial Wrapped Body",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "JIANGSU HANHE DAILY CHEMICALS CO., LTD.",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. For washing to decrease bacteria on skin."
},
{
"NDCCode": "77667-201-01",
"PackageDescription": "75 mL in 1 BOTTLE (77667-201-01) ",
"NDC11Code": "77667-0201-01",
"ProductNDC": "77667-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "75% Alcohol Disinfectant",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Heyuan Jiabaosheng health daily necessities 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": "75% alcohol disinfectant to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "80707-201-06",
"PackageDescription": "75 CLOTH in 1 BOTTLE (80707-201-06) ",
"NDC11Code": "80707-0201-06",
"ProductNDC": "80707-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Disinfecting Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Hangzhou Muzi Commodity Co., Ltd",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".0052",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "DISINFECTING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "81160-201-01",
"PackageDescription": "75 g in 1 TUBE (81160-201-01) ",
"NDC11Code": "81160-0201-01",
"ProductNDC": "81160-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ato Standard Premium Mildcream",
"NonProprietaryName": "Butyrospermum Park2 Shea Butter, Centella Asiatica Extract, Ceramide Np",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "TIMEBIO Co., Ltd",
"SubstanceName": "CENTELLA ASIATICA WHOLE; CERAMIDE NP; SHEA BUTTER",
"StrengthNumber": ".005; .0018; 3",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Apply daily to skin needs special care like dry skin as needed and smooth to help absorption."
},
{
"NDCCode": "90042-201-15",
"PackageDescription": "75 CLOTH in 1 CANISTER (90042-201-15) ",
"NDC11Code": "90042-0201-15",
"ProductNDC": "90042-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Wipes",
"NonProprietaryName": "Benzalkonium Chloride, Didecyldimonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shandong mengyida daily necessities Co., Ltd.",
"SubstanceName": "DIDECYLDIMONIUM CHLORIDE; BENZALKONIUM CHLORIDE",
"StrengthNumber": ".2; .1",
"StrengthUnit": "1/1001; 1/1001",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "ANTIBACTERIAL WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "68682-003-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (68682-003-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "68682-0003-10",
"ProductNDC": "68682-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bexarotene",
"NonProprietaryName": "Bexarotene",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20151217",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021055",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "BEXAROTENE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151217",
"SamplePackage": "N",
"IndicationAndUsage": "Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.",
"Description": "Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl)ethenyl]benzoic acid, and the structural formula is as follows:. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, NF, polyethylene glycol 400, NF, polysorbate 20, NF, and povidone, USP. The capsule shell contains gelatin, NF, sorbitol special glycerin blend, and titanium dioxide, USP."
},
{
"NDCCode": "68682-231-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-231-01) ",
"NDC11Code": "68682-0231-01",
"ProductNDC": "68682-231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azathioprine",
"NonProprietaryName": "Azathioprine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075252",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "AZATHIOPRINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230204",
"SamplePackage": "N",
"IndicationAndUsage": "Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine Tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathioprine Tablets are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with Azathioprine Tablets. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of Azathioprine Tablets with these agents cannot be recommended.",
"Description": "Azathioprine, an immunosuppressive antimetabolite, is available in tablet form for oral administration. Each scored tablet contains 75 mg or 100 mg azathioprine and the inactive ingredients lactose monohydrate, pregelatinized starch, povidone, corn starch, magnesium stearate, and stearic acid. Azathioprine is chemically 6-[(1-methyl-4-nitro-1 H-imidazol-5-yl)thio]-1 H-purine. The structural formula of azathioprine is. It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound. Azathioprine is insoluble in water, but may be dissolved with addition of one molar equivalent of alkali. Azathioprine is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide (0.1N), especially on warming. Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione, and hydrogen sulfide."
},
{
"NDCCode": "68682-241-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (68682-241-01) ",
"NDC11Code": "68682-0241-01",
"ProductNDC": "68682-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azathioprine",
"NonProprietaryName": "Azathioprine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075252",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "AZATHIOPRINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230204",
"SamplePackage": "N",
"IndicationAndUsage": "Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine Tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathioprine Tablets are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with Azathioprine Tablets. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of Azathioprine Tablets with these agents cannot be recommended.",
"Description": "Azathioprine, an immunosuppressive antimetabolite, is available in tablet form for oral administration. Each scored tablet contains 75 mg or 100 mg azathioprine and the inactive ingredients lactose monohydrate, pregelatinized starch, povidone, corn starch, magnesium stearate, and stearic acid. Azathioprine is chemically 6-[(1-methyl-4-nitro-1 H-imidazol-5-yl)thio]-1 H-purine. The structural formula of azathioprine is. It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound. Azathioprine is insoluble in water, but may be dissolved with addition of one molar equivalent of alkali. Azathioprine is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide (0.1N), especially on warming. Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione, and hydrogen sulfide."
},
{
"NDCCode": "68682-993-98",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-993-98) ",
"NDC11Code": "68682-0993-98",
"ProductNDC": "68682-993",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075116",
"LabelerName": "OCEANSIDE PHARMACEUTICALS",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991228",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsule is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate 80, povidone K30, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution Test 12. For oral administration."
},
{
"NDCCode": "68682-994-98",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-994-98) ",
"NDC11Code": "68682-0994-98",
"ProductNDC": "68682-994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075116",
"LabelerName": "OCEANSIDE PHARMACEUTICALS",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991228",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsule is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate 80, povidone K30, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution Test 12. For oral administration."
},
{
"NDCCode": "68682-997-98",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-997-98) ",
"NDC11Code": "68682-0997-98",
"ProductNDC": "68682-997",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075116",
"LabelerName": "OCEANSIDE PHARMACEUTICALS",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991228",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsule is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate 80, povidone K30, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution Test 12. For oral administration."
},
{
"NDCCode": "68682-998-98",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-998-98) ",
"NDC11Code": "68682-0998-98",
"ProductNDC": "68682-998",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075116",
"LabelerName": "OCEANSIDE PHARMACEUTICALS",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991228",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsule is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate 80, povidone K30, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution Test 12. For oral administration."
},
{
"NDCCode": "10812-201-01",
"PackageDescription": "10 g in 1 TUBE (10812-201-01) ",
"NDC11Code": "10812-0201-01",
"ProductNDC": "10812-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Moistureshine Lip Soother",
"ProprietaryNameSuffix": "Sunscreen Spf20 - Shine 30",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130611",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "75; 20",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130611",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "11489-201-01",
"PackageDescription": "1 JAR in 1 CARTON (11489-201-01) / 50 g in 1 JAR",
"NDC11Code": "11489-0201-01",
"ProductNDC": "11489-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Protect And Perfect Intense Advanced Fragrance Free Day Cream Spf 30",
"NonProprietaryName": "Avobenzone,octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160630",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.5; 2.5; 3.75",
"StrengthUnit": "g/50g; g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231204",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m-2 p.m. wear long-sleeved shirts, pants, hats and sunglasses.",
"Description": "FINE LINES APPEAR VISIBLY REDUCED IN 2 WEEKS. No7 Protect & Perfect Intense ADVANCED FRAGRANCE FREE Day Cream Sunscreen Broad Spectrum SPF 30. Fine lines & wrinkles appear visibly reduced. 50 ml e 1.69 US Fl. Oz. ADVANCED formula, all day hydration, for visibly younger looking skin. Protect & Perfect Intense ADVANCED Day Cream combines the protective power of SPF 30, our unique Double Defence technology and our No7 age defying ingredients to reduce the appearance of the visible signs of ageing. This Day Cream visibly reduced the appearance of fine lines and wrinkles, and helps protect skin from future signs of ageing. instantly skin looks more radiant. After 2 weeks skin looks younger, by 4 weeks fine lines and wrinkles appear visibly reduced. Formulated with. - Ginseng Extract. This day cream fights the look of tiredness and fatigue, leaving skin feeling instantly energized to face the day ahead. - Double Defence Technology. This day cream helps protect the skin from environmental stressors. - Hyaluronic Acid. This day cream leaves skin feeling instantly moisturized. - MATRIXYL 3000 PLUS: Our next generation anti-wrinkle peptide technology. For best results: Use every morning after cleansing and applying Protect & Perfect Intense ADVANCED Serum. Apply evenly over your face and neck with your fingertips, avoiding the eye area. Suitable for Sensitive Skin."
},
{
"NDCCode": "16571-201-06",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06) ",
"NDC11Code": "16571-0201-06",
"ProductNDC": "16571-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080819",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow."
},
{
"NDCCode": "16571-201-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-10) ",
"NDC11Code": "16571-0201-10",
"ProductNDC": "16571-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080819",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow."
},
{
"NDCCode": "16571-201-11",
"PackageDescription": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-11) ",
"NDC11Code": "16571-0201-11",
"ProductNDC": "16571-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080819",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow."
},
{
"NDCCode": "16571-201-50",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-50) ",
"NDC11Code": "16571-0201-50",
"ProductNDC": "16571-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080819",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow."
},
{
"NDCCode": "24338-201-01",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 KIT (24338-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "24338-0201-01",
"ProductNDC": "24338-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sutab",
"NonProprietaryName": "Sodium Sulfate, Magnesium Sulfate, And Potassium Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213135",
"LabelerName": "Azurity Pharmaceuticals, Inc.",
"SubstanceName": "SODIUM SULFATE; MAGNESIUM SULFATE ANHYDROUS; POTASSIUM CHLORIDE",
"StrengthNumber": "17.75; 2.7; 2.25",
"StrengthUnit": "g/1; g/1; g/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.",
"Description": "SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets is an orally administered osmotic laxative and is provided as two bottles, each containing 12 tablets. Each tablet contains: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. Inactive ingredients include: polyethylene glycol 8000, sodium caprylate, and ethylene glycol and vinyl alcohol graft copolymer. Sodium Sulfate, USP. The molecular formula is Na2SO4. The average molecular weight is 142.04. The structural formula is:. Magnesium Sulfate, USP. The molecular formula is MgSO4. The average molecular weight is 120.37. The structural formula is:. Potassium Chloride, USP. The molecular formula is KCl. The average molecular weight is 74.55. The structural formula is."
},
{
"NDCCode": "42003-201-01",
"PackageDescription": "50 CLOTH in 1 BAG (42003-201-01) ",
"NDC11Code": "42003-0201-01",
"ProductNDC": "42003-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sanitizing Wipes",
"NonProprietaryName": "Alcohol Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Jiayan Daily Commodity Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/1001",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68682-201-75</NDCCode>
<PackageDescription>1 KIT in 1 CONTAINER (68682-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH</PackageDescription>
<NDC11Code>68682-0201-75</NDC11Code>
<ProductNDC>68682-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Peg-3350, Electrolytes, And Ascorbate</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, And Ascorbic Acid</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20061001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021881</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative consisting of 4 pouches (2 of Pouch A and 2 of Pouch B) containing white to yellow powder for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride, plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring containing citral, lime oil, maltodextrin, acacia gum, vitamin E, and other natural flavoring agents. Pouch A contains 111.9 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. Pouch B contains 10.6 g of powder for oral solution. When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an oral solution having a lemon taste. The entire, reconstituted, 2-liter Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution colon preparation contains 200 grams of polyethylene glycol-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 131 mg per treatment.</Description>
</NDC>
<NDC>
<NDCCode>68682-272-75</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (68682-272-75) / 7.5 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>68682-0272-75</NDC11Code>
<ProductNDC>68682-272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imiquimod</ProprietaryName>
<NonProprietaryName>Imiquimod</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022483</ApplicationNumber>
<LabelerName>Oceanside Pharmacueticals</LabelerName>
<SubstanceName>IMIQUIMOD</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults. ( 1.1) . Imiquimod Cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. ( 1.2) .</IndicationAndUsage>
<Description>Imiquimod Cream, 3.75% is for topical administration. Each gram contains 37.5 mg of imiquimod, respectively, in a white to faintly yellow oil-in-water cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum. Chemically, imiquimod is 1-(2-methylpropyl)-1 H-imidazol[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C 14H 16N 4and a molecular weight of 240.3. Its structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>68682-462-75</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68682-462-75) / 75 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68682-0462-75</NDC11Code>
<ProductNDC>68682-462</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180608</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050782</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, Clindamycin Phosphate Topical Gel applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table. There was a trend in the investigator’s global assessment of the results, which favored Clindamycin Phosphate Topical Gel QD over the vehicle QD. In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to Clindamycin Phosphate Topical Gel. There was no signal for contact sensitization in the clinical trials under normal use conditions.</IndicationAndUsage>
<Description>Clindamycin Phosphate Topical Gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula represented below:. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).</Description>
</NDC>
<NDC>
<NDCCode>11410-201-76</NDCCode>
<PackageDescription>1 JAR in 1 BOX (11410-201-76) > 75 CLOTH in 1 JAR (11410-201-75)</PackageDescription>
<NDC11Code>11410-0201-76</NDC11Code>
<ProductNDC>11410-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Clear Zone Body Pads</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Guthy-Renker LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.036</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43239-201-13</NDCCode>
<PackageDescription>75 g in 1 TUBE (43239-201-13)</PackageDescription>
<NDC11Code>43239-0201-13</NDC11Code>
<ProductNDC>43239-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120710</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ERBAVIVA INC.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>HELPS PREVENT SUNBURN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61126-201-75</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (61126-201-75)</PackageDescription>
<NDC11Code>61126-0201-75</NDC11Code>
<ProductNDC>61126-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefzil</ProprietaryName>
<NonProprietaryName>Cefprozil</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161206</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050665</ApplicationNumber>
<LabelerName>Corden Pharma Latina S.p.A.</LabelerName>
<SubstanceName>CEFPROZIL</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>65649-201-75</NDCCode>
<PackageDescription>1 KIT in 1 CONTAINER (65649-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH</PackageDescription>
<NDC11Code>65649-0201-75</NDC11Code>
<ProductNDC>65649-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moviprep</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20061001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021881</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MoviPrep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution) is an osmotic laxative consisting of 4 pouches (2 of Pouch A and 2 of Pouch B) containing white to yellow powder for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride, plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring containing citral, lime oil, maltodextrin, acacia gum, vitamin E, and other natural flavoring agents. Pouch A contains 111.9 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. Pouch B contains 10.6 g of powder for oral solution. When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) is an oral solution having a lemon taste. The entire, reconstituted, 2-liter MoviPrep colon preparation contains 200 grams of polyethylene glycol (PEG) 3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 131 mg per treatment.</Description>
</NDC>
<NDC>
<NDCCode>66326-201-05</NDCCode>
<PackageDescription>75 kg in 1 DRUM (66326-201-05) </PackageDescription>
<NDC11Code>66326-0201-05</NDC11Code>
<ProductNDC>66326-201</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20191230</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Sri Krishna Pharmaceuticals Ltd. Unit I</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>g/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-DEC-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68428-201-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-201-03) </PackageDescription>
<NDC11Code>68428-0201-03</NDC11Code>
<ProductNDC>68428-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amygdalus Persica</ProprietaryName>
<NonProprietaryName>Peach</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110126</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>PRUNUS PERSICA FLOWER</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70626-201-51</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (70626-201-51) / 75 mL in 1 TUBE (70626-201-31) </PackageDescription>
<NDC11Code>70626-0201-51</NDC11Code>
<ProductNDC>70626-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Picture Perfect Day Daily Moisturizer</ProprietaryName>
<NonProprietaryName>Avobenzone, Octocrylene, Octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160502</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ASPIRE BRANDS INC</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2; 3; 6</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160502</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>73027-201-03</NDCCode>
<PackageDescription>144 CELLO PACK in 1 CASE (73027-201-03) > 75 g in 1 CELLO PACK</PackageDescription>
<NDC11Code>73027-0201-03</NDC11Code>
<ProductNDC>73027-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bob Barker Antibacterial Wrapped Body</ProprietaryName>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>JIANGSU HANHE DAILY CHEMICALS CO., LTD.</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. For washing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77667-201-01</NDCCode>
<PackageDescription>75 mL in 1 BOTTLE (77667-201-01) </PackageDescription>
<NDC11Code>77667-0201-01</NDC11Code>
<ProductNDC>77667-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>75% Alcohol Disinfectant</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Heyuan Jiabaosheng health 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>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>75% alcohol disinfectant to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80707-201-06</NDCCode>
<PackageDescription>75 CLOTH in 1 BOTTLE (80707-201-06) </PackageDescription>
<NDC11Code>80707-0201-06</NDC11Code>
<ProductNDC>80707-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disinfecting Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Hangzhou Muzi Commodity Co., Ltd</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.0052</StrengthNumber>
<StrengthUnit>mg/1</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>DISINFECTING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81160-201-01</NDCCode>
<PackageDescription>75 g in 1 TUBE (81160-201-01) </PackageDescription>
<NDC11Code>81160-0201-01</NDC11Code>
<ProductNDC>81160-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ato Standard Premium Mildcream</ProprietaryName>
<NonProprietaryName>Butyrospermum Park2 Shea Butter, Centella Asiatica Extract, Ceramide Np</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>TIMEBIO Co., Ltd</LabelerName>
<SubstanceName>CENTELLA ASIATICA WHOLE; CERAMIDE NP; SHEA BUTTER</SubstanceName>
<StrengthNumber>.005; .0018; 3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply daily to skin needs special care like dry skin as needed and smooth to help absorption.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>90042-201-15</NDCCode>
<PackageDescription>75 CLOTH in 1 CANISTER (90042-201-15) </PackageDescription>
<NDC11Code>90042-0201-15</NDC11Code>
<ProductNDC>90042-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride, Didecyldimonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shandong mengyida daily necessities Co., Ltd.</LabelerName>
<SubstanceName>DIDECYLDIMONIUM CHLORIDE; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.2; .1</StrengthNumber>
<StrengthUnit>1/1001; 1/1001</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>ANTIBACTERIAL WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68682-003-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68682-003-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>68682-0003-10</NDC11Code>
<ProductNDC>68682-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bexarotene</ProprietaryName>
<NonProprietaryName>Bexarotene</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151217</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021055</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>BEXAROTENE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.</IndicationAndUsage>
<Description>Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl)ethenyl]benzoic acid, and the structural formula is as follows:. Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C24H28O2. It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: butylated hydroxyanisole, NF, polyethylene glycol 400, NF, polysorbate 20, NF, and povidone, USP. The capsule shell contains gelatin, NF, sorbitol special glycerin blend, and titanium dioxide, USP.</Description>
</NDC>
<NDC>
<NDCCode>68682-231-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-231-01) </PackageDescription>
<NDC11Code>68682-0231-01</NDC11Code>
<ProductNDC>68682-231</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azathioprine</ProprietaryName>
<NonProprietaryName>Azathioprine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075252</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>AZATHIOPRINE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine Tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathioprine Tablets are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with Azathioprine Tablets. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of Azathioprine Tablets with these agents cannot be recommended.</IndicationAndUsage>
<Description>Azathioprine, an immunosuppressive antimetabolite, is available in tablet form for oral administration. Each scored tablet contains 75 mg or 100 mg azathioprine and the inactive ingredients lactose monohydrate, pregelatinized starch, povidone, corn starch, magnesium stearate, and stearic acid. Azathioprine is chemically 6-[(1-methyl-4-nitro-1 H-imidazol-5-yl)thio]-1 H-purine. The structural formula of azathioprine is. It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound. Azathioprine is insoluble in water, but may be dissolved with addition of one molar equivalent of alkali. Azathioprine is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide (0.1N), especially on warming. Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione, and hydrogen sulfide.</Description>
</NDC>
<NDC>
<NDCCode>68682-241-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68682-241-01) </PackageDescription>
<NDC11Code>68682-0241-01</NDC11Code>
<ProductNDC>68682-241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azathioprine</ProprietaryName>
<NonProprietaryName>Azathioprine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075252</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>AZATHIOPRINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine Tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathioprine Tablets are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with Azathioprine Tablets. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of Azathioprine Tablets with these agents cannot be recommended.</IndicationAndUsage>
<Description>Azathioprine, an immunosuppressive antimetabolite, is available in tablet form for oral administration. Each scored tablet contains 75 mg or 100 mg azathioprine and the inactive ingredients lactose monohydrate, pregelatinized starch, povidone, corn starch, magnesium stearate, and stearic acid. Azathioprine is chemically 6-[(1-methyl-4-nitro-1 H-imidazol-5-yl)thio]-1 H-purine. The structural formula of azathioprine is. It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound. Azathioprine is insoluble in water, but may be dissolved with addition of one molar equivalent of alkali. Azathioprine is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide (0.1N), especially on warming. Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione, and hydrogen sulfide.</Description>
</NDC>
<NDC>
<NDCCode>68682-993-98</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-993-98) </PackageDescription>
<NDC11Code>68682-0993-98</NDC11Code>
<ProductNDC>68682-993</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075116</ApplicationNumber>
<LabelerName>OCEANSIDE PHARMACEUTICALS</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsule is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate 80, povidone K30, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution Test 12. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>68682-994-98</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-994-98) </PackageDescription>
<NDC11Code>68682-0994-98</NDC11Code>
<ProductNDC>68682-994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075116</ApplicationNumber>
<LabelerName>OCEANSIDE PHARMACEUTICALS</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsule is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate 80, povidone K30, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution Test 12. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>68682-997-98</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-997-98) </PackageDescription>
<NDC11Code>68682-0997-98</NDC11Code>
<ProductNDC>68682-997</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075116</ApplicationNumber>
<LabelerName>OCEANSIDE PHARMACEUTICALS</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsule is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate 80, povidone K30, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution Test 12. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>68682-998-98</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-998-98) </PackageDescription>
<NDC11Code>68682-0998-98</NDC11Code>
<ProductNDC>68682-998</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075116</ApplicationNumber>
<LabelerName>OCEANSIDE PHARMACEUTICALS</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsule is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate 80, povidone K30, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-Release Capsule meets USP Dissolution Test 12. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>10812-201-01</NDCCode>
<PackageDescription>10 g in 1 TUBE (10812-201-01) </PackageDescription>
<NDC11Code>10812-0201-01</NDC11Code>
<ProductNDC>10812-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Moistureshine Lip Soother</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Spf20 - Shine 30</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130611</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11489-201-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11489-201-01) / 50 g in 1 JAR</PackageDescription>
<NDC11Code>11489-0201-01</NDC11Code>
<ProductNDC>11489-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Protect And Perfect Intense Advanced Fragrance Free Day Cream Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone,octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.5; 2.5; 3.75</StrengthNumber>
<StrengthUnit>g/50g; g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m-2 p.m. wear long-sleeved shirts, pants, hats and sunglasses.</IndicationAndUsage>
<Description>FINE LINES APPEAR VISIBLY REDUCED IN 2 WEEKS. No7 Protect & Perfect Intense ADVANCED FRAGRANCE FREE Day Cream Sunscreen Broad Spectrum SPF 30. Fine lines & wrinkles appear visibly reduced. 50 ml e 1.69 US Fl. Oz. ADVANCED formula, all day hydration, for visibly younger looking skin. Protect & Perfect Intense ADVANCED Day Cream combines the protective power of SPF 30, our unique Double Defence technology and our No7 age defying ingredients to reduce the appearance of the visible signs of ageing. This Day Cream visibly reduced the appearance of fine lines and wrinkles, and helps protect skin from future signs of ageing. instantly skin looks more radiant. After 2 weeks skin looks younger, by 4 weeks fine lines and wrinkles appear visibly reduced. Formulated with. - Ginseng Extract. This day cream fights the look of tiredness and fatigue, leaving skin feeling instantly energized to face the day ahead. - Double Defence Technology. This day cream helps protect the skin from environmental stressors. - Hyaluronic Acid. This day cream leaves skin feeling instantly moisturized. - MATRIXYL 3000 PLUS: Our next generation anti-wrinkle peptide technology. For best results: Use every morning after cleansing and applying Protect & Perfect Intense ADVANCED Serum. Apply evenly over your face and neck with your fingertips, avoiding the eye area. Suitable for Sensitive Skin.</Description>
</NDC>
<NDC>
<NDCCode>16571-201-06</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06) </PackageDescription>
<NDC11Code>16571-0201-06</NDC11Code>
<ProductNDC>16571-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>16571-201-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-10) </PackageDescription>
<NDC11Code>16571-0201-10</NDC11Code>
<ProductNDC>16571-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>16571-201-11</NDCCode>
<PackageDescription>1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-11) </PackageDescription>
<NDC11Code>16571-0201-11</NDC11Code>
<ProductNDC>16571-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>16571-201-50</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-50) </PackageDescription>
<NDC11Code>16571-0201-50</NDC11Code>
<ProductNDC>16571-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration and Perforation). Diclofenac sodium delayed-release tablets are indicated: 1 For relief of the signs and symptoms of osteoarthritis, 2 For relief of the signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is. C14H10Cl2NNaO2 M.W. 318.14. Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, hypromellose, iron oxide red, iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>24338-201-01</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 KIT (24338-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>24338-0201-01</NDC11Code>
<ProductNDC>24338-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sutab</ProprietaryName>
<NonProprietaryName>Sodium Sulfate, Magnesium Sulfate, And Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213135</ApplicationNumber>
<LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SODIUM SULFATE; MAGNESIUM SULFATE ANHYDROUS; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>17.75; 2.7; 2.25</StrengthNumber>
<StrengthUnit>g/1; g/1; g/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets is an orally administered osmotic laxative and is provided as two bottles, each containing 12 tablets. Each tablet contains: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. Inactive ingredients include: polyethylene glycol 8000, sodium caprylate, and ethylene glycol and vinyl alcohol graft copolymer. Sodium Sulfate, USP. The molecular formula is Na2SO4. The average molecular weight is 142.04. The structural formula is:. Magnesium Sulfate, USP. The molecular formula is MgSO4. The average molecular weight is 120.37. The structural formula is:. Potassium Chloride, USP. The molecular formula is KCl. The average molecular weight is 74.55. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>42003-201-01</NDCCode>
<PackageDescription>50 CLOTH in 1 BAG (42003-201-01) </PackageDescription>
<NDC11Code>42003-0201-01</NDC11Code>
<ProductNDC>42003-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sanitizing Wipes</ProprietaryName>
<NonProprietaryName>Alcohol Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Jiayan Daily Commodity Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
</NDCList>