{
"NDC": [
{
"NDCCode": "74680-111-45",
"PackageDescription": "80 g in 1 CANISTER (74680-111-45) ",
"NDC11Code": "74680-0111-45",
"ProductNDC": "74680-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germ-away",
"NonProprietaryName": "Antibacterial",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200824",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Unico International Trading Corp",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200824",
"SamplePackage": "N",
"IndicationAndUsage": "Pop off canister lid. Remove or puncture seal. Pull out center wipe and thread through lid opening. Snap lid back onto the canister."
},
{
"NDCCode": "30142-111-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-111-12) > 45 mL in 1 BOTTLE",
"NDC11Code": "30142-0111-12",
"ProductNDC": "30142-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oral Saline Laxative",
"ProprietaryNameSuffix": "Ginger Lemon",
"NonProprietaryName": "Dibasic Sodium Phosphate, Monobasic Sodium Phosphate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "The Kroger Company",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "2.7; 7.2",
"StrengthUnit": "g/15mL; g/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for relief of occasional constipation."
},
{
"NDCCode": "41163-111-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (41163-111-12) > 45 mL in 1 BOTTLE",
"NDC11Code": "41163-0111-12",
"ProductNDC": "41163-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oral Saline Laxative",
"NonProprietaryName": "Dibasic Sodium Phosphate, Monobasic Sodium Phosphate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120716",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "SuperValu, Inc.",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "2.7; 7.2",
"StrengthUnit": "g/15mL; g/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for relief of occasional constipation."
},
{
"NDCCode": "42808-111-45",
"PackageDescription": "1 TUBE in 1 CARTON (42808-111-45) > 45 g in 1 TUBE",
"NDC11Code": "42808-0111-45",
"ProductNDC": "42808-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfacetamide, Sulfur",
"NonProprietaryName": "Sodium Sulfacetamide, Sulfur",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Exact-Rx, Inc.",
"SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-08-29"
},
{
"NDCCode": "44019-111-01",
"PackageDescription": "1 PATCH in 1 POUCH (44019-111-01) > .45 g in 1 PATCH",
"NDC11Code": "44019-0111-01",
"ProductNDC": "44019-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Prep Pad - Medium",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Yinjing Medical Technology (Shanghai) Co., Ltd.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "For preparation of the skin prior to injection."
},
{
"NDCCode": "49348-111-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (49348-111-12) > 45 mL in 1 BOTTLE",
"NDC11Code": "49348-0111-12",
"ProductNDC": "49348-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oral Saline Laxative",
"ProprietaryNameSuffix": "Ginger Lemon",
"NonProprietaryName": "Dibasic Sodium Phosphate, Monobasic Sodium Phosphate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Mckesson Corporation",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "2.7; 7.2",
"StrengthUnit": "g/15mL; g/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for relief of occasional constipation."
},
{
"NDCCode": "49364-111-45",
"PackageDescription": "45 CAPSULE in 1 BOTTLE (49364-111-45)",
"NDC11Code": "49364-0111-45",
"ProductNDC": "49364-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065248",
"LabelerName": "Strategic Pharmaceutical Solutions, Inc. DBA VetSource",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by S. pneumoniae and S. pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis. Skin and skin structure infections caused by staphylococci and/or streptococci. Bone infections caused by staphylococci and/or P. mirabilis. Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae. Note - Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 μmol) or 500 mg (1439 μmol) of cephalexin. The capsules also contain the following inactive ingredients: Croscarmellose Sodium, D & C Yellow No. 10, F D & C Blue No.1, F D & C Yellow No. 6, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Titanium Dioxide. Ink constituents are: Black Iron Oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Shellac and Strong Ammonia Solution."
},
{
"NDCCode": "49738-111-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (49738-111-12) > 45 mL in 1 BOTTLE",
"NDC11Code": "49738-0111-12",
"ProductNDC": "49738-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oral Saline Laxative",
"ProprietaryNameSuffix": "Ginger Lemon",
"NonProprietaryName": "Dibasic Sodium Phosphate, Monobasic Sodium Phosphate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Kmart Corporation",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "2.7; 7.2",
"StrengthUnit": "g/15mL; g/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for relief of occasional constipation."
},
{
"NDCCode": "53329-111-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (53329-111-12) > 45 mL in 1 BOTTLE",
"NDC11Code": "53329-0111-12",
"ProductNDC": "53329-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Curad Oral Saline Laxative",
"NonProprietaryName": "Dibasic Sodium Phosphate, Monobasic Sodium Phosphate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120716",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Medline Industries, Inc.",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "2.9; 7.2",
"StrengthUnit": "g/15mL; g/15mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "59779-111-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-111-12) > 45 mL in 1 BOTTLE",
"NDC11Code": "59779-0111-12",
"ProductNDC": "59779-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oral Saline Laxative",
"ProprietaryNameSuffix": "Ginger Lemon",
"NonProprietaryName": "Dibasic Sodium Phosphate, Monobasic Sodium Phosphate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120831",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM",
"StrengthNumber": "1.4; 6.2",
"StrengthUnit": "g/14.7868mL; g/14.7868mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20120831",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves occasional constipation."
},
{
"NDCCode": "60429-111-45",
"PackageDescription": "450 TABLET in 1 BOTTLE (60429-111-45) ",
"NDC11Code": "60429-0111-45",
"ProductNDC": "60429-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203769",
"LabelerName": "Golden State Medical Supply",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20131023",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "N"
},
{
"NDCCode": "63517-111-02",
"PackageDescription": "200 PATCH in 1 BOX (63517-111-02) > .45 g in 1 PATCH",
"NDC11Code": "63517-0111-02",
"ProductNDC": "63517-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cardinalhealth Alcohol Prep Pads Medium",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130414",
"EndMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Cardinal Health",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20160803",
"EndMarketingDatePackage": "20180101",
"SamplePackage": "N"
},
{
"NDCCode": "71105-111-03",
"PackageDescription": "50 PACKET in 1 BOX (71105-111-03) > 1 PATCH in 1 PACKET (71105-111-02) > .45 g in 1 PATCH (71105-111-01) ",
"NDC11Code": "71105-0111-03",
"ProductNDC": "71105-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Pad",
"NonProprietaryName": "Alcohol Prep Pad",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Redicare LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170331",
"SamplePackage": "N",
"IndicationAndUsage": "Store at room temperature 15 o to 30 oC (59 o to 86 oF)."
},
{
"NDCCode": "71610-111-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (71610-111-45) ",
"NDC11Code": "71610-0111-45",
"ProductNDC": "71610-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040419",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180809",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mgCodeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
},
{
"NDCCode": "76381-111-45",
"PackageDescription": "5 SYRINGE, GLASS in 1 BOX (76381-111-45) > 17 mL in 1 SYRINGE, GLASS",
"NDC11Code": "76381-0111-45",
"ProductNDC": "76381-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prohance",
"NonProprietaryName": "Gadoteridol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19921116",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020131",
"LabelerName": "BIPSO GmbH",
"SubstanceName": "GADOTERIDOL",
"StrengthNumber": "279.3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-10-10"
},
{
"NDCCode": "82876-221-40",
"PackageDescription": "111.45 g in 1 JAR (82876-221-40) ",
"NDC11Code": "82876-0221-40",
"ProductNDC": "82876-221",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healing Hand Cream 2000mg",
"NonProprietaryName": "Menthol",
"DosageFormName": "SALVE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Carolina Cannabis Creations LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "1.4",
"StrengthUnit": "g/111.45g",
"Status": "Active",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains."
},
{
"NDCCode": "83659-111-03",
"PackageDescription": "24 BOTTLE in 1 BOX (83659-111-03) / .45 L in 1 BOTTLE",
"NDC11Code": "83659-0111-03",
"ProductNDC": "83659-111",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20230901",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jilin Province New Tianlong Industry Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "100",
"StrengthUnit": "L/100L",
"Status": "Unfinished",
"LastUpdate": "2026-03-18",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-SEP-23"
},
{
"NDCCode": "0316-2062-45",
"PackageDescription": "148 mL in 1 TUBE (0316-2062-45) ",
"NDC11Code": "00316-2062-45",
"ProductNDC": "0316-2062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Kids Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE",
"StrengthNumber": "111; 59.5; 55.5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210209",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2072-45",
"PackageDescription": "148 mL in 1 TUBE (0316-2072-45) ",
"NDC11Code": "00316-2072-45",
"ProductNDC": "0316-2072",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Active Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55.5; 59.5; 111",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210209",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2075-45",
"PackageDescription": "148 mL in 1 TUBE (0316-2075-45) ",
"NDC11Code": "00316-2075-45",
"ProductNDC": "0316-2075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Sport Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Crown Laboratories",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55.5; 59.5; 111",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N"
},
{
"NDCCode": "13668-111-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-01) ",
"NDC11Code": "13668-0111-01",
"ProductNDC": "13668-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "13668-111-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-05) ",
"NDC11Code": "13668-0111-05",
"ProductNDC": "13668-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "13668-111-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-30) ",
"NDC11Code": "13668-0111-30",
"ProductNDC": "13668-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetin Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090774",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).",
"Description": "Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide)."
},
{
"NDCCode": "27505-111-14",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (27505-111-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "27505-0111-14",
"ProductNDC": "27505-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xadago",
"NonProprietaryName": "Safinamide Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170508",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207145",
"LabelerName": "MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.",
"SubstanceName": "SAFINAMIDE MESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170508",
"SamplePackage": "N",
"IndicationAndUsage": "XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing \"off\" episodes.",
"Description": "XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below. The molecular formula of safinamide mesylate is C 17H 19FN 2O 2∙CH 4O 3S and its molecular weight is 398.45. Safinamide mesylate is a white to off-white crystalline powder. Safinamide mesylate is freely soluble in water, methanol and dimethyl sulfoxide. Safinamide mesylate is sparingly soluble in ethanol and is practically insoluble in ethyl acetate. In aqueous buffers that span a pH range of 1.2 to 7.5, safinamide mesylate is highly soluble at pH 1.2 and 4.5, but shows low solubility (<0.4 mg/mL) at pH 6.8 and 7.5. XADAGO is available as 50 mg and 100 mg film-coated tablets for oral administration. Each XADAGO tablet contains 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg, respectively, of safinamide free base. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide (red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, potassium aluminum silicate, and titanium dioxide."
},
{
"NDCCode": "27505-111-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (27505-111-30) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "27505-0111-30",
"ProductNDC": "27505-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xadago",
"NonProprietaryName": "Safinamide Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170508",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207145",
"LabelerName": "MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.",
"SubstanceName": "SAFINAMIDE MESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170508",
"SamplePackage": "N",
"IndicationAndUsage": "XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing \"off\" episodes.",
"Description": "XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below. The molecular formula of safinamide mesylate is C 17H 19FN 2O 2∙CH 4O 3S and its molecular weight is 398.45. Safinamide mesylate is a white to off-white crystalline powder. Safinamide mesylate is freely soluble in water, methanol and dimethyl sulfoxide. Safinamide mesylate is sparingly soluble in ethanol and is practically insoluble in ethyl acetate. In aqueous buffers that span a pH range of 1.2 to 7.5, safinamide mesylate is highly soluble at pH 1.2 and 4.5, but shows low solubility (<0.4 mg/mL) at pH 6.8 and 7.5. XADAGO is available as 50 mg and 100 mg film-coated tablets for oral administration. Each XADAGO tablet contains 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg, respectively, of safinamide free base. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide (red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, potassium aluminum silicate, and titanium dioxide."
},
{
"NDCCode": "27505-111-90",
"PackageDescription": "1 BOTTLE in 1 CARTON (27505-111-90) / 90 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "27505-0111-90",
"ProductNDC": "27505-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xadago",
"NonProprietaryName": "Safinamide Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170508",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207145",
"LabelerName": "MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.",
"SubstanceName": "SAFINAMIDE MESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170508",
"SamplePackage": "N",
"IndicationAndUsage": "XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing \"off\" episodes.",
"Description": "XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below. The molecular formula of safinamide mesylate is C 17H 19FN 2O 2∙CH 4O 3S and its molecular weight is 398.45. Safinamide mesylate is a white to off-white crystalline powder. Safinamide mesylate is freely soluble in water, methanol and dimethyl sulfoxide. Safinamide mesylate is sparingly soluble in ethanol and is practically insoluble in ethyl acetate. In aqueous buffers that span a pH range of 1.2 to 7.5, safinamide mesylate is highly soluble at pH 1.2 and 4.5, but shows low solubility (<0.4 mg/mL) at pH 6.8 and 7.5. XADAGO is available as 50 mg and 100 mg film-coated tablets for oral administration. Each XADAGO tablet contains 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg, respectively, of safinamide free base. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide (red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, potassium aluminum silicate, and titanium dioxide."
},
{
"NDCCode": "59310-111-06",
"PackageDescription": "1 POUCH in 1 CARTON (59310-111-06) / 1 INHALER in 1 POUCH / 1 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0111-06",
"ProductNDC": "59310-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airduo Digihaler",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208799",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "55; 14",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.",
"Description": "AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized."
},
{
"NDCCode": "61973-111-04",
"PackageDescription": "120 g in 1 BOTTLE (61973-111-04) ",
"NDC11Code": "61973-0111-04",
"ProductNDC": "61973-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arizona Sun Spf 45 Golfblok Sunscreen",
"NonProprietaryName": "Sunscreen",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240221",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Arizona Sun Products",
"SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE; OXYBENZONE",
"StrengthNumber": "100; 70; 50; 30; 75; 50",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240221",
"SamplePackage": "N",
"IndicationAndUsage": "Provides high sunburn protection. Higher SPF gives more sunburn protection."
},
{
"NDCCode": "62135-111-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (62135-111-01) ",
"NDC11Code": "62135-0111-01",
"ProductNDC": "62135-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "62135-111-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (62135-111-30) ",
"NDC11Code": "62135-0111-30",
"ProductNDC": "62135-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
}
]
}
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<NDC>
<NDCCode>74680-111-45</NDCCode>
<PackageDescription>80 g in 1 CANISTER (74680-111-45) </PackageDescription>
<NDC11Code>74680-0111-45</NDC11Code>
<ProductNDC>74680-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germ-away</ProprietaryName>
<NonProprietaryName>Antibacterial</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200824</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Unico International Trading Corp</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pop off canister lid. Remove or puncture seal. Pull out center wipe and thread through lid opening. Snap lid back onto the canister.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-111-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-111-12) > 45 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0111-12</NDC11Code>
<ProductNDC>30142-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oral Saline Laxative</ProprietaryName>
<ProprietaryNameSuffix>Ginger Lemon</ProprietaryNameSuffix>
<NonProprietaryName>Dibasic Sodium Phosphate, Monobasic Sodium Phosphate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>The Kroger Company</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
<StrengthNumber>2.7; 7.2</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for relief of occasional constipation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41163-111-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41163-111-12) > 45 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41163-0111-12</NDC11Code>
<ProductNDC>41163-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oral Saline Laxative</ProprietaryName>
<NonProprietaryName>Dibasic Sodium Phosphate, Monobasic Sodium Phosphate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120716</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>SuperValu, Inc.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
<StrengthNumber>2.7; 7.2</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for relief of occasional constipation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42808-111-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42808-111-45) > 45 g in 1 TUBE</PackageDescription>
<NDC11Code>42808-0111-45</NDC11Code>
<ProductNDC>42808-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfacetamide, Sulfur</ProprietaryName>
<NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Exact-Rx, Inc.</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>44019-111-01</NDCCode>
<PackageDescription>1 PATCH in 1 POUCH (44019-111-01) > .45 g in 1 PATCH</PackageDescription>
<NDC11Code>44019-0111-01</NDC11Code>
<ProductNDC>44019-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Prep Pad - Medium</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Yinjing Medical Technology (Shanghai) Co., Ltd.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For preparation of the skin prior to injection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49348-111-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49348-111-12) > 45 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49348-0111-12</NDC11Code>
<ProductNDC>49348-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oral Saline Laxative</ProprietaryName>
<ProprietaryNameSuffix>Ginger Lemon</ProprietaryNameSuffix>
<NonProprietaryName>Dibasic Sodium Phosphate, Monobasic Sodium Phosphate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Mckesson Corporation</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
<StrengthNumber>2.7; 7.2</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for relief of occasional constipation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49364-111-45</NDCCode>
<PackageDescription>45 CAPSULE in 1 BOTTLE (49364-111-45)</PackageDescription>
<NDC11Code>49364-0111-45</NDC11Code>
<ProductNDC>49364-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065248</ApplicationNumber>
<LabelerName>Strategic Pharmaceutical Solutions, Inc. DBA VetSource</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by S. pneumoniae and S. pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis. Skin and skin structure infections caused by staphylococci and/or streptococci. Bone infections caused by staphylococci and/or P. mirabilis. Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae. Note - Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 μmol) or 500 mg (1439 μmol) of cephalexin. The capsules also contain the following inactive ingredients: Croscarmellose Sodium, D & C Yellow No. 10, F D & C Blue No.1, F D & C Yellow No. 6, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Titanium Dioxide. Ink constituents are: Black Iron Oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Shellac and Strong Ammonia Solution.</Description>
</NDC>
<NDC>
<NDCCode>49738-111-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49738-111-12) > 45 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49738-0111-12</NDC11Code>
<ProductNDC>49738-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oral Saline Laxative</ProprietaryName>
<ProprietaryNameSuffix>Ginger Lemon</ProprietaryNameSuffix>
<NonProprietaryName>Dibasic Sodium Phosphate, Monobasic Sodium Phosphate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Kmart Corporation</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
<StrengthNumber>2.7; 7.2</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for relief of occasional constipation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53329-111-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (53329-111-12) > 45 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>53329-0111-12</NDC11Code>
<ProductNDC>53329-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Curad Oral Saline Laxative</ProprietaryName>
<NonProprietaryName>Dibasic Sodium Phosphate, Monobasic Sodium Phosphate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120716</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Medline Industries, Inc.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
<StrengthNumber>2.9; 7.2</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>59779-111-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59779-111-12) > 45 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0111-12</NDC11Code>
<ProductNDC>59779-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oral Saline Laxative</ProprietaryName>
<ProprietaryNameSuffix>Ginger Lemon</ProprietaryNameSuffix>
<NonProprietaryName>Dibasic Sodium Phosphate, Monobasic Sodium Phosphate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>1.4; 6.2</StrengthNumber>
<StrengthUnit>g/14.7868mL; g/14.7868mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves occasional constipation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60429-111-45</NDCCode>
<PackageDescription>450 TABLET in 1 BOTTLE (60429-111-45) </PackageDescription>
<NDC11Code>60429-0111-45</NDC11Code>
<ProductNDC>60429-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203769</ApplicationNumber>
<LabelerName>Golden State Medical Supply</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131023</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63517-111-02</NDCCode>
<PackageDescription>200 PATCH in 1 BOX (63517-111-02) > .45 g in 1 PATCH</PackageDescription>
<NDC11Code>63517-0111-02</NDC11Code>
<ProductNDC>63517-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cardinalhealth Alcohol Prep Pads Medium</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130414</StartMarketingDate>
<EndMarketingDate>20180101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160803</StartMarketingDatePackage>
<EndMarketingDatePackage>20180101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71105-111-03</NDCCode>
<PackageDescription>50 PACKET in 1 BOX (71105-111-03) > 1 PATCH in 1 PACKET (71105-111-02) > .45 g in 1 PATCH (71105-111-01) </PackageDescription>
<NDC11Code>71105-0111-03</NDC11Code>
<ProductNDC>71105-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Pad</ProprietaryName>
<NonProprietaryName>Alcohol Prep Pad</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Redicare LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Store at room temperature 15 o to 30 oC (59 o to 86 oF).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-111-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE (71610-111-45) </PackageDescription>
<NDC11Code>71610-0111-45</NDC11Code>
<ProductNDC>71610-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040419</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 1 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mgCodeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>76381-111-45</NDCCode>
<PackageDescription>5 SYRINGE, GLASS in 1 BOX (76381-111-45) > 17 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>76381-0111-45</NDC11Code>
<ProductNDC>76381-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prohance</ProprietaryName>
<NonProprietaryName>Gadoteridol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19921116</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020131</ApplicationNumber>
<LabelerName>BIPSO GmbH</LabelerName>
<SubstanceName>GADOTERIDOL</SubstanceName>
<StrengthNumber>279.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>82876-221-40</NDCCode>
<PackageDescription>111.45 g in 1 JAR (82876-221-40) </PackageDescription>
<NDC11Code>82876-0221-40</NDC11Code>
<ProductNDC>82876-221</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healing Hand Cream 2000mg</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>SALVE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Carolina Cannabis Creations LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>g/111.45g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83659-111-03</NDCCode>
<PackageDescription>24 BOTTLE in 1 BOX (83659-111-03) / .45 L in 1 BOTTLE</PackageDescription>
<NDC11Code>83659-0111-03</NDC11Code>
<ProductNDC>83659-111</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20230901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jilin Province New Tianlong Industry Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-18</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-SEP-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0316-2062-45</NDCCode>
<PackageDescription>148 mL in 1 TUBE (0316-2062-45) </PackageDescription>
<NDC11Code>00316-2062-45</NDC11Code>
<ProductNDC>0316-2062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Kids Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE</SubstanceName>
<StrengthNumber>111; 59.5; 55.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2072-45</NDCCode>
<PackageDescription>148 mL in 1 TUBE (0316-2072-45) </PackageDescription>
<NDC11Code>00316-2072-45</NDC11Code>
<ProductNDC>0316-2072</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Active Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55.5; 59.5; 111</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2075-45</NDCCode>
<PackageDescription>148 mL in 1 TUBE (0316-2075-45) </PackageDescription>
<NDC11Code>00316-2075-45</NDC11Code>
<ProductNDC>0316-2075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Sport Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55.5; 59.5; 111</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13668-111-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-01) </PackageDescription>
<NDC11Code>13668-0111-01</NDC11Code>
<ProductNDC>13668-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
</NDC>
<NDC>
<NDCCode>13668-111-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-05) </PackageDescription>
<NDC11Code>13668-0111-05</NDC11Code>
<ProductNDC>13668-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
</NDC>
<NDC>
<NDCCode>13668-111-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-30) </PackageDescription>
<NDC11Code>13668-0111-30</NDC11Code>
<ProductNDC>13668-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090774</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults (1), 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1), 3 Diabetic peripheral neuropathic pain (DPNP) in adults (1), 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age older (1), 5 Chronic musculoskeletal pain in adults (1).</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.45, 33.68, or 67.36 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include. 20 mg: FD&C Blue No. 2, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac). 30 mg: FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, black imprinting ink (It contains black iron oxide, potassium hydroxide, propylene glycol, and shellac), white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide). 60 mg: FD&C Blue No. 2, gelatin, hypromellose, iron oxide yellow, methacrylic acid copolymer dispersion, polyethylene glycol 400, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, white imprinting ink (It contains povidone, shellac, sodium hydroxide, and titanium dioxide).</Description>
</NDC>
<NDC>
<NDCCode>27505-111-14</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (27505-111-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>27505-0111-14</NDC11Code>
<ProductNDC>27505-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xadago</ProprietaryName>
<NonProprietaryName>Safinamide Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170508</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207145</ApplicationNumber>
<LabelerName>MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SAFINAMIDE MESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.</IndicationAndUsage>
<Description>XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below. The molecular formula of safinamide mesylate is C 17H 19FN 2O 2∙CH 4O 3S and its molecular weight is 398.45. Safinamide mesylate is a white to off-white crystalline powder. Safinamide mesylate is freely soluble in water, methanol and dimethyl sulfoxide. Safinamide mesylate is sparingly soluble in ethanol and is practically insoluble in ethyl acetate. In aqueous buffers that span a pH range of 1.2 to 7.5, safinamide mesylate is highly soluble at pH 1.2 and 4.5, but shows low solubility (<0.4 mg/mL) at pH 6.8 and 7.5. XADAGO is available as 50 mg and 100 mg film-coated tablets for oral administration. Each XADAGO tablet contains 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg, respectively, of safinamide free base. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide (red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, potassium aluminum silicate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>27505-111-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (27505-111-30) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>27505-0111-30</NDC11Code>
<ProductNDC>27505-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xadago</ProprietaryName>
<NonProprietaryName>Safinamide Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170508</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207145</ApplicationNumber>
<LabelerName>MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SAFINAMIDE MESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.</IndicationAndUsage>
<Description>XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below. The molecular formula of safinamide mesylate is C 17H 19FN 2O 2∙CH 4O 3S and its molecular weight is 398.45. Safinamide mesylate is a white to off-white crystalline powder. Safinamide mesylate is freely soluble in water, methanol and dimethyl sulfoxide. Safinamide mesylate is sparingly soluble in ethanol and is practically insoluble in ethyl acetate. In aqueous buffers that span a pH range of 1.2 to 7.5, safinamide mesylate is highly soluble at pH 1.2 and 4.5, but shows low solubility (<0.4 mg/mL) at pH 6.8 and 7.5. XADAGO is available as 50 mg and 100 mg film-coated tablets for oral administration. Each XADAGO tablet contains 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg, respectively, of safinamide free base. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide (red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, potassium aluminum silicate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>27505-111-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (27505-111-90) / 90 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>27505-0111-90</NDC11Code>
<ProductNDC>27505-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xadago</ProprietaryName>
<NonProprietaryName>Safinamide Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170508</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207145</ApplicationNumber>
<LabelerName>MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SAFINAMIDE MESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.</IndicationAndUsage>
<Description>XADAGO tablets contain safinamide, which is a MAO-B inhibitor, as the mesylate salt. Safinamide mesylate is (S)-2- [[4-[(3-fluorophenyl) methoxy]phenyl]methyl]aminopropanamide methanesulfonate (1:1) and its structural formula is below. The molecular formula of safinamide mesylate is C 17H 19FN 2O 2∙CH 4O 3S and its molecular weight is 398.45. Safinamide mesylate is a white to off-white crystalline powder. Safinamide mesylate is freely soluble in water, methanol and dimethyl sulfoxide. Safinamide mesylate is sparingly soluble in ethanol and is practically insoluble in ethyl acetate. In aqueous buffers that span a pH range of 1.2 to 7.5, safinamide mesylate is highly soluble at pH 1.2 and 4.5, but shows low solubility (<0.4 mg/mL) at pH 6.8 and 7.5. XADAGO is available as 50 mg and 100 mg film-coated tablets for oral administration. Each XADAGO tablet contains 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg, respectively, of safinamide free base. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide (red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, potassium aluminum silicate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59310-111-06</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-111-06) / 1 INHALER in 1 POUCH / 1 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0111-06</NDC11Code>
<ProductNDC>59310-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Airduo Digihaler</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208799</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>55; 14</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized.</Description>
</NDC>
<NDC>
<NDCCode>61973-111-04</NDCCode>
<PackageDescription>120 g in 1 BOTTLE (61973-111-04) </PackageDescription>
<NDC11Code>61973-0111-04</NDC11Code>
<ProductNDC>61973-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arizona Sun Spf 45 Golfblok Sunscreen</ProprietaryName>
<NonProprietaryName>Sunscreen</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240221</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Arizona Sun Products</LabelerName>
<SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>100; 70; 50; 30; 75; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Provides high sunburn protection. Higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62135-111-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (62135-111-01) </PackageDescription>
<NDC11Code>62135-0111-01</NDC11Code>
<ProductNDC>62135-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>62135-111-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (62135-111-30) </PackageDescription>
<NDC11Code>62135-0111-30</NDC11Code>
<ProductNDC>62135-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
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