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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090306",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "Indomethacin extended-release capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16CINO 4, and it has the following chemical structure. Indomethacin is a pale yellow to yellow-tan crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Extended-Release Capsules, 75 mg include. corn starch, D&C Yellow # 10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. This product meets USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "11994-016-01",
"PackageDescription": "3 mL in 1 VIAL, SINGLE-DOSE (11994-016-01) ",
"NDC11Code": "11994-0016-01",
"ProductNDC": "11994-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quadramet",
"NonProprietaryName": "Samarium Sm 153 Lexidronam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970519",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020570",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "SAMARIUM SM-153 LEXIDRONAM PENTASODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mCi/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19970519",
"SamplePackage": "N"
},
{
"NDCCode": "13733-016-01",
"PackageDescription": "25 g in 1 CARTON (13733-016-01)",
"NDC11Code": "13733-0016-01",
"ProductNDC": "13733-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha Glam Silky Body Balm",
"ProprietaryNameSuffix": "Spf 27",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ABLE C&C CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "1.88; 1.5; .48",
"StrengthUnit": "g/25g; g/25g; g/25g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INDICATION AND USAGE: Apply as desired with encased puff."
},
{
"NDCCode": "14141-016-01",
"PackageDescription": "1 CASE in 1 BOX (14141-016-01) > 9 g in 1 CASE",
"NDC11Code": "14141-0016-01",
"ProductNDC": "14141-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 330-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "75; 78.4",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "14445-016-01",
"PackageDescription": "5 kg in 1 DRUM (14445-016-01) ",
"NDC11Code": "14445-0016-01",
"ProductNDC": "14445-016",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Alogliptin Benzoate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "ALOGLIPTIN BENZOATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "30-JUN-16"
},
{
"NDCCode": "14783-016-01",
"PackageDescription": "1 g in 1 PACKET (14783-016-01)",
"NDC11Code": "14783-0016-01",
"ProductNDC": "14783-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Lederm 45plus Jour",
"ProprietaryNameSuffix": "Spf 15 Facial Treatment Against Noticeable Signs Of Aging Day - Oily Skin",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .05; .03; .05",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-016-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (16714-016-10) / .4 mL in 1 SYRINGE (16714-016-01) ",
"NDC11Code": "16714-0016-10",
"ProductNDC": "16714-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enoxaparin Sodium",
"NonProprietaryName": "Enoxaparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206834",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "ENOXAPARIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191201",
"SamplePackage": "N",
"IndicationAndUsage": "Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .",
"Description": "Enoxaparin Sodium Injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. * X = Percent of polysaccharide chain containing 1,6-anhydro derivative on the reducing end. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "17714-016-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (17714-016-01)",
"NDC11Code": "17714-0016-01",
"ProductNDC": "17714-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Allergy",
"NonProprietaryName": "Chlorpheniramine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Advance Pharmaceutical Inc.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2017-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020109",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies : 1 runny nose, 2 itchy nose or throat, 3 sneezing, 4 itchy, watery eyes."
},
{
"NDCCode": "18124-016-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (18124-016-01) > 1.1 mL in 1 SYRINGE",
"NDC11Code": "18124-0016-01",
"ProductNDC": "18124-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"NonProprietaryName": "Hydroxyprogesterone Caproate",
"DosageFormName": "INJECTION",
"StartMarketingDate": "20110203",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Fresenius Kabi Austria GmbH",
"SubstanceName": "HYDROXYPROGESTERONE CAPROATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2022-11-15",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "03-FEB-11"
},
{
"NDCCode": "22100-016-01",
"PackageDescription": "236 g in 1 BOTTLE (22100-016-01)",
"NDC11Code": "22100-0016-01",
"ProductNDC": "22100-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Healing Waters Island Nectar Scented Anti-bacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110507",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "NINGBO MEIDUO GENERAL PRODUCTS CO., LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses: To decrease bacteria on the skin that could cause diseases. Recommended for repeated use."
},
{
"NDCCode": "24463-016-01",
"PackageDescription": "1 JAR in 1 CARTON (24463-016-01) > 50 g in 1 JAR",
"NDC11Code": "24463-0016-01",
"ProductNDC": "24463-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Flawless Skin Repair Day Broad Spectrum Spf 15 Sunscreen",
"NonProprietaryName": "Octinoxate, Avobenzone, Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161025",
"EndMarketingDate": "20230228",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "JO Cosmetics Co., Ltd.",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".8; 3.5; .5",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161025",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "N"
},
{
"NDCCode": "24724-016-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (24724-016-01) ",
"NDC11Code": "24724-0016-01",
"ProductNDC": "24724-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079148",
"LabelerName": "INDICUS PHARMA LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090603",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients Sodium Starch Glycolate, Povidone, Corn Starch, Colloidal Silicon Dioxide and Magnesium Stearate. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry White which contains: Hypromellose, Talc, Polyethylene glycol and Titanium dioxide."
},
{
"NDCCode": "25225-016-01",
"PackageDescription": "1 CLOTH in 1 POUCH (25225-016-01)",
"NDC11Code": "25225-0016-01",
"ProductNDC": "25225-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100503",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Unique Holding Group Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "1/1001",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions. Adults and children two years and over: 1 Apply to hands, 2 Allow skin to dry without wiping.",
"Description": "Uses. To decrease bacteria on the skin that could cause diseases. Recommended for repeated use."
},
{
"NDCCode": "25682-016-12",
"PackageDescription": "12 VIAL in 1 CARTON (25682-016-12) / 1 mL in 1 VIAL (25682-016-01) ",
"NDC11Code": "25682-0016-12",
"ProductNDC": "25682-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strensiq",
"NonProprietaryName": "Asfotase Alfa",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20151023",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125513",
"LabelerName": "Alexion Pharmaceuticals, Inc.",
"SubstanceName": "ASFOTASE ALFA",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"IndicationAndUsage": "STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).",
"Description": "Asfotase alfa is a tissue nonspecific alkaline phosphatase (TNSALP) produced by recombinant DNA technology in a Chinese hamster ovary cell line. Asfotase alfa is a soluble glycoprotein composed of two identical polypeptide chains. Each chain contains 726 amino acids with a theoretical mass of 161 kDa. Each chain consists of the catalytic domain of human TNSALP, the human immunoglobulin G1 Fc domain and a deca-aspartate peptide used as a bone targeting domain. The two polypeptide chains are covalently linked by two disulfide bonds. STRENSIQ (asfotase alfa) injection is a sterile, preservative-free, nonpyrogenic, clear, slightly opalescent or opalescent, colorless to slightly yellow, with few small translucent or white particles, aqueous solution for subcutaneous administration. STRENSIQ is supplied in glass single-dose vials containing asfotase alfa; dibasic sodium phosphate, heptahydrate; monobasic sodium phosphate, monohydrate; and sodium chloride at a pH between 7.2 and 7.6. Table 5 describes the content of STRENSIQ vial presentations."
},
{
"NDCCode": "27293-016-01",
"PackageDescription": "1 TUBE in 1 BOX (27293-016-01) > 28 g in 1 TUBE (27293-016-28)",
"NDC11Code": "27293-0016-01",
"ProductNDC": "27293-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Budpak First Aid",
"NonProprietaryName": "Lidocaine Hcl And Phenol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130612",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Budpak Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; PHENOL",
"StrengthNumber": ".005; .005",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Uses: 1 first aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns."
},
{
"NDCCode": "33332-016-01",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (33332-016-01) > .5 mL in 1 SYRINGE, GLASS (33332-016-02)",
"NDC11Code": "33332-0016-01",
"ProductNDC": "33332-016",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Afluria",
"NonProprietaryName": "Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (propiolactone Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20110715",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125254",
"LabelerName": "Seqirus Pty Ltd",
"SubstanceName": "INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient],Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "36800-016-01",
"PackageDescription": "1 TUBE in 1 CARTON (36800-016-01) > 14.2 g in 1 TUBE",
"NDC11Code": "36800-0016-01",
"ProductNDC": "36800-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare",
"ProprietaryNameSuffix": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19951214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "37000-017-01",
"PackageDescription": "1 KIT in 1 PACKAGE (37000-017-01) * 354 mL in 1 BOTTLE, PLASTIC (37000-032-03) * 12 TABLET in 1 BOTTLE, PLASTIC (37000-016-12) ",
"NDC11Code": "37000-0017-01",
"ProductNDC": "37000-017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pepto-bismol And Pepto-bismol To Go",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "KIT",
"StartMarketingDate": "20120917",
"EndMarketingDate": "20181031",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Deprecated",
"LastUpdate": "2018-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120917",
"EndMarketingDatePackage": "20181031",
"SamplePackage": "N"
},
{
"NDCCode": "37012-016-01",
"PackageDescription": "1 TUBE in 1 CARTON (37012-016-01) > 14.2 g in 1 TUBE",
"NDC11Code": "37012-0016-01",
"ProductNDC": "37012-016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shopko",
"ProprietaryNameSuffix": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19951214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Shopko Stores Operating Co., LLC",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns."
},
{
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{
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},
{
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}
]
}
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<SamplePackage>Y</SamplePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERTZYE® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
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<ProductNDC>59767-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pertzye</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120517</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA022175</ApplicationNumber>
<LabelerName>Digestive Care, Inc.</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>16000; 60500; 57500</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120517</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PERTZYE® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated microspheres in PERTZYE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PERTZYE (pancrelipase) delayed-release capsules are for oral administration, include a two-piece hard gelatin shell containing light tan/cream-colored bicarbonate-buffered enteric-coated microspheres ranging in size from 0.8 to 1.4 mm in diameter for 4,000 USP units of lipase and 0.8 to 2.2 mm in diameter for 8,000, 16,000, and 24,000 USP units of lipase, and are available as follows. 4,000 USP units of lipase; 14,375 USP units of protease; and 15,125 USP units of amylase; delayed-release capsules have a clear body printed in green with "4" and a clear cap printed with a green circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac, and ammonium hydroxide. 8,000 USP units of lipase; 28,750 USP units of protease; and 30,250 USP units of amylase; delayed-release capsules have a clear body printed in blue with "8" and a clear cap printed with a blue circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac, and ammonium hydroxide. 16,000 USP units of lipase; 57,500 USP units of protease; and 60,500 USP units of amylase; delayed-release capsules have a clear body printed in red with "16" and a clear cap printed with a red circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac. 24,000 USP units of lipase; 86,250 USP units of protease; and 90,750 USP units of amylase; delayed-release capsules have a clear body printed in purple with "24" and a clear cap printed with a purple circular stripe and "DCI". The imprinting ink on the capsule contains FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac. PERTZYE (pancrelipase) delayed-release capsules include the following inactive ingredients: cellulose acetate phthalate, diethyl phthalate, polyvinylpyrrolidone, sodium bicarbonate, sodium carbonate, sodium starch glycolate, talc, and ursodiol.</Description>
</NDC>
<NDC>
<NDCCode>10348-016-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10348-016-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>10348-0016-01</NDC11Code>
<ProductNDC>10348-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Photo Finish Foundation Primer Broad Spectrum Sp 20 With Dermaxyl Complex</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, And Octisalate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>.019; .1425; .0475</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10702-016-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-01) </PackageDescription>
<NDC11Code>10702-0016-01</NDC11Code>
<ProductNDC>10702-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079175</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>Indomethacin extended-release capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16CINO 4, and it has the following chemical structure. Indomethacin is a pale yellow to yellow-tan crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Extended-Release Capsules, 75 mg include. corn starch, D&C Yellow # 10, gelatin, mannitol, povidone, sucrose, talc, and titanium dioxide. This product meets USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>11994-016-01</NDCCode>
<PackageDescription>3 mL in 1 VIAL, SINGLE-DOSE (11994-016-01) </PackageDescription>
<NDC11Code>11994-0016-01</NDC11Code>
<ProductNDC>11994-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quadramet</ProprietaryName>
<NonProprietaryName>Samarium Sm 153 Lexidronam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970519</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020570</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>SAMARIUM SM-153 LEXIDRONAM PENTASODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13733-016-01</NDCCode>
<PackageDescription>25 g in 1 CARTON (13733-016-01)</PackageDescription>
<NDC11Code>13733-0016-01</NDC11Code>
<ProductNDC>13733-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha Glam Silky Body Balm</ProprietaryName>
<ProprietaryNameSuffix>Spf 27</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ABLE C&C CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.88; 1.5; .48</StrengthNumber>
<StrengthUnit>g/25g; g/25g; g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INDICATION AND USAGE: Apply as desired with encased puff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-016-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-016-01) > 9 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0016-01</NDC11Code>
<ProductNDC>14141-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 330-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>75; 78.4</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14445-016-01</NDCCode>
<PackageDescription>5 kg in 1 DRUM (14445-016-01) </PackageDescription>
<NDC11Code>14445-0016-01</NDC11Code>
<ProductNDC>14445-016</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Alogliptin Benzoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160630</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALOGLIPTIN BENZOATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-JUN-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14783-016-01</NDCCode>
<PackageDescription>1 g in 1 PACKET (14783-016-01)</PackageDescription>
<NDC11Code>14783-0016-01</NDC11Code>
<ProductNDC>14783-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Lederm 45plus Jour</ProprietaryName>
<ProprietaryNameSuffix>Spf 15 Facial Treatment Against Noticeable Signs Of Aging Day - Oily Skin</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>.03; .05; .03; .05</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-016-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (16714-016-10) / .4 mL in 1 SYRINGE (16714-016-01) </PackageDescription>
<NDC11Code>16714-0016-10</NDC11Code>
<ProductNDC>16714-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enoxaparin Sodium</ProprietaryName>
<NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206834</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .</IndicationAndUsage>
<Description>Enoxaparin Sodium Injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. * X = Percent of polysaccharide chain containing 1,6-anhydro derivative on the reducing end. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>17714-016-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (17714-016-01)</PackageDescription>
<NDC11Code>17714-0016-01</NDC11Code>
<ProductNDC>17714-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Allergy</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Advance Pharmaceutical Inc.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies : 1 runny nose, 2 itchy nose or throat, 3 sneezing, 4 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>18124-016-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (18124-016-01) > 1.1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>18124-0016-01</NDC11Code>
<ProductNDC>18124-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<NonProprietaryName>Hydroxyprogesterone Caproate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<StartMarketingDate>20110203</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Fresenius Kabi Austria GmbH</LabelerName>
<SubstanceName>HYDROXYPROGESTERONE CAPROATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-15</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-FEB-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>22100-016-01</NDCCode>
<PackageDescription>236 g in 1 BOTTLE (22100-016-01)</PackageDescription>
<NDC11Code>22100-0016-01</NDC11Code>
<ProductNDC>22100-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Healing Waters Island Nectar Scented Anti-bacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110507</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>NINGBO MEIDUO GENERAL PRODUCTS CO., LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: To decrease bacteria on the skin that could cause diseases. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24463-016-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (24463-016-01) > 50 g in 1 JAR</PackageDescription>
<NDC11Code>24463-0016-01</NDC11Code>
<ProductNDC>24463-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Flawless Skin Repair Day Broad Spectrum Spf 15 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate, Avobenzone, Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161025</StartMarketingDate>
<EndMarketingDate>20230228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>JO Cosmetics Co., Ltd.</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.8; 3.5; .5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161025</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24724-016-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (24724-016-01) </PackageDescription>
<NDC11Code>24724-0016-01</NDC11Code>
<ProductNDC>24724-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079148</ApplicationNumber>
<LabelerName>INDICUS PHARMA LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients Sodium Starch Glycolate, Povidone, Corn Starch, Colloidal Silicon Dioxide and Magnesium Stearate. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry White which contains: Hypromellose, Talc, Polyethylene glycol and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>25225-016-01</NDCCode>
<PackageDescription>1 CLOTH in 1 POUCH (25225-016-01)</PackageDescription>
<NDC11Code>25225-0016-01</NDC11Code>
<ProductNDC>25225-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100503</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Unique Holding Group Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>1/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Adults and children two years and over: 1 Apply to hands, 2 Allow skin to dry without wiping.</IndicationAndUsage>
<Description>Uses. To decrease bacteria on the skin that could cause diseases. Recommended for repeated use.</Description>
</NDC>
<NDC>
<NDCCode>25682-016-12</NDCCode>
<PackageDescription>12 VIAL in 1 CARTON (25682-016-12) / 1 mL in 1 VIAL (25682-016-01) </PackageDescription>
<NDC11Code>25682-0016-12</NDC11Code>
<ProductNDC>25682-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strensiq</ProprietaryName>
<NonProprietaryName>Asfotase Alfa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20151023</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125513</ApplicationNumber>
<LabelerName>Alexion Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ASFOTASE ALFA</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).</IndicationAndUsage>
<Description>Asfotase alfa is a tissue nonspecific alkaline phosphatase (TNSALP) produced by recombinant DNA technology in a Chinese hamster ovary cell line. Asfotase alfa is a soluble glycoprotein composed of two identical polypeptide chains. Each chain contains 726 amino acids with a theoretical mass of 161 kDa. Each chain consists of the catalytic domain of human TNSALP, the human immunoglobulin G1 Fc domain and a deca-aspartate peptide used as a bone targeting domain. The two polypeptide chains are covalently linked by two disulfide bonds. STRENSIQ (asfotase alfa) injection is a sterile, preservative-free, nonpyrogenic, clear, slightly opalescent or opalescent, colorless to slightly yellow, with few small translucent or white particles, aqueous solution for subcutaneous administration. STRENSIQ is supplied in glass single-dose vials containing asfotase alfa; dibasic sodium phosphate, heptahydrate; monobasic sodium phosphate, monohydrate; and sodium chloride at a pH between 7.2 and 7.6. Table 5 describes the content of STRENSIQ vial presentations.</Description>
</NDC>
<NDC>
<NDCCode>27293-016-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (27293-016-01) > 28 g in 1 TUBE (27293-016-28)</PackageDescription>
<NDC11Code>27293-0016-01</NDC11Code>
<ProductNDC>27293-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Budpak First Aid</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Phenol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130612</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Budpak Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; PHENOL</SubstanceName>
<StrengthNumber>.005; .005</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: 1 first aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33332-016-01</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (33332-016-01) > .5 mL in 1 SYRINGE, GLASS (33332-016-02)</PackageDescription>
<NDC11Code>33332-0016-01</NDC11Code>
<ProductNDC>33332-016</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Afluria</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/california/7/2009 X-181 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (propiolactone Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (propiolactone Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20110715</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125254</ApplicationNumber>
<LabelerName>Seqirus Pty Ltd</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Pharm_Classes>Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient],Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>36800-016-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (36800-016-01) > 14.2 g in 1 TUBE</PackageDescription>
<NDC11Code>36800-0016-01</NDC11Code>
<ProductNDC>36800-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare</ProprietaryName>
<ProprietaryNameSuffix>Triple Antibiotic</ProprietaryNameSuffix>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19951214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37000-017-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (37000-017-01) * 354 mL in 1 BOTTLE, PLASTIC (37000-032-03) * 12 TABLET in 1 BOTTLE, PLASTIC (37000-016-12) </PackageDescription>
<NDC11Code>37000-0017-01</NDC11Code>
<ProductNDC>37000-017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pepto-bismol And Pepto-bismol To Go</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120917</StartMarketingDate>
<EndMarketingDate>20181031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120917</StartMarketingDatePackage>
<EndMarketingDatePackage>20181031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37012-016-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37012-016-01) > 14.2 g in 1 TUBE</PackageDescription>
<NDC11Code>37012-0016-01</NDC11Code>
<ProductNDC>37012-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shopko</ProprietaryName>
<ProprietaryNameSuffix>Triple Antibiotic</ProprietaryNameSuffix>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19951214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Shopko Stores Operating Co., LLC</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>40335-016-01</NDCCode>
<PackageDescription>1 L in 1 BOTTLE (40335-016-01) </PackageDescription>
<NDC11Code>40335-0016-01</NDC11Code>
<ProductNDC>40335-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>EXTRACORPOREAL</RouteName>
<StartMarketingDate>20200616</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Guangdong Qiaoqiao Biological Technology Co.,Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>L/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>40562-016-01</NDCCode>
<PackageDescription>30 PATCH in 1 PACKET (40562-016-01) > 4 mL in 1 PATCH</PackageDescription>
<NDC11Code>40562-0016-01</NDC11Code>
<ProductNDC>40562-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disinfecting Wipes</ProprietaryName>
<NonProprietaryName>Disinfecting Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Anhui Hanbon Daily Chemical Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid help to prevent the risk of infection in: 1 Minor cuts, 2 Scrapes, 3 Burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>40760-016-01</NDCCode>
<PackageDescription>30 CLOTH in 1 BAG (40760-016-01) </PackageDescription>
<NDC11Code>40760-0016-01</NDC11Code>
<ProductNDC>40760-016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disinfecting Wipes</ProprietaryName>
<NonProprietaryName>Disinfecting Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200716</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Huzhou Guoneng New Material Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>132.35</StrengthNumber>
<StrengthUnit>mL/301</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.Tear off the package of the wipes and pull out the wipes. 2.Wipe the articles or parts to be cleaned with the wipes. 3. please stricty fllowo the garbage classification requirements after use.</IndicationAndUsage>
</NDC>
</NDCList>