{
"NDC": [
{
"NDCCode": "87247-139-19",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (87247-139-19) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0139-19",
"ProductNDC": "87247-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sour Lemon Hand Sanitizer Sugar Macaron Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-139-09",
"PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (87247-139-09) / 35 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0139-09",
"ProductNDC": "87247-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sour Lemon Hand Sanitizer Sugar Macaron Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "87247-418-19",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (87247-418-19) / 40 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "87247-0418-19",
"ProductNDC": "87247-418",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Chocolate Chip Pancake Scent",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Life Cosmetics Trading FZCO",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260219",
"SamplePackage": "N",
"IndicationAndUsage": " To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use."
},
{
"NDCCode": "61786-139-19",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (61786-139-19)",
"NDC11Code": "61786-0139-19",
"ProductNDC": "61786-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077056",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-03-10"
},
{
"NDCCode": "68703-139-29",
"PackageDescription": "19 g in 1 BOTTLE, GLASS (68703-139-29)",
"NDC11Code": "68703-0139-29",
"ProductNDC": "68703-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prostate Relief",
"NonProprietaryName": "Chimaphila Umb, Clematis Virg, Conium, Cubeba, Sabal",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130826",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Silver Star Brands, Inc",
"SubstanceName": "CHIMAPHILA UMBELLATA; CLEMATIS VIRGINIANA TOP; CONIUM MACULATUM FLOWERING TOP; PIPER CUBEBA FRUIT; SAW PALMETTO",
"StrengthNumber": "6; 6; 6; 6; 6",
"StrengthUnit": "[hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_C]/19g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69842-139-19",
"PackageDescription": "1 BOTTLE in 1 BOX (69842-139-19) > 89 mL in 1 BOTTLE (69842-139-18) ",
"NDC11Code": "69842-0139-19",
"ProductNDC": "69842-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health",
"ProprietaryNameSuffix": "Am Moisturizing Facial",
"NonProprietaryName": "Homosalate, Octinoxate, Zinc Oxide, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170203",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "120; 75; 20; 35",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170203",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "0054-0711-19",
"PackageDescription": "50 TABLET, COATED in 1 BOTTLE (0054-0711-19) ",
"NDC11Code": "00054-0711-19",
"ProductNDC": "0054-0711",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferiprone",
"NonProprietaryName": "Deferiprone",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213239",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DEFERIPRONE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Limitations of Use: 1 Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.",
"Description": "Deferiprone tablets contain 1,000 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C7H9NO2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula. Deferiprone is a white crystalline powder. It is slightly soluble in deionized water and has a melting point range of 271°C - 273°C. Deferiprone Tablets (three times a day), 1,000 mg. Deferiprone tablets, 1,000 mg are white to off-white, modified capsule shaped, biconvex, film coated tablet, debossed with 54 [score] 23 on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core: methylcellulose, crospovidone, magnesium stearate; Coating: hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide."
},
{
"NDCCode": "10122-100-11",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-100-11) ",
"NDC11Code": "10122-0100-11",
"ProductNDC": "10122-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ferriprox",
"NonProprietaryName": "Deferiprone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021825",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "DEFERIPRONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitations of Use. Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.",
"Description": "FERRIPROX Tablets (deferiprone) contain 1,000 mg or 500 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C7H9NO2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula. Deferiprone is a white to pinkish-white powder. It is sparingly soluble in deionized water (14.3 mg/mL) and has a melting point range of 272 °C - 278 °C. FERRIPROX Tablets (twice a day), 1,000 mg. White to off-white, capsule-shaped tablets, and imprinted with “FPX” score “DR” on one side and “APO” score “1000” on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core - hypromellose acetate succinate, magnesium oxide, colloidal silicon dioxide and magnesium stearate; Coating - triethyl citrate, talc, titanium dioxide, and methacrylic acid and ethyl acrylate copolymer. FERRIPROX Tablets (three times a day), 1,000 mg. White to off-white, capsule-shaped tablets, and imprinted with “APO” score “1000” on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core - methylcellulose, crospovidone, and magnesium stearate; Coating - hypromellose, hydroxypropyl cellulose, macrogol, and titanium dioxide. FERRIPROX Tablets, 500 mg. White to off-white, capsule-shaped tablets, and imprinted with “APO” score “500” on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 500 mg deferiprone and the following inactive ingredients: Tablet core - microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide; Coating - hypromellose, polyethylene glycol, titanium dioxide."
},
{
"NDCCode": "24979-139-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24979-139-01) ",
"NDC11Code": "24979-0139-01",
"ProductNDC": "24979-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Hydrochloride",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215848",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below. Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains FD&C Blue No. 1 Aluminum Lake (2.5 mg tablet), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 5 mg tablets), D&C Red No. 27 Aluminum Lake (5 mg tablet), FD&C Yellow No. 6 Aluminum Lake (10 mg tablet), lactose monohydrate, hypromellos, microcrystalline cellulose, magnesium stearate, polyethylene glycol 3350, polyvinyl alcohol, purified water, talc and titanium dioxide."
},
{
"NDCCode": "25000-139-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (25000-139-03) ",
"NDC11Code": "25000-0139-03",
"ProductNDC": "25000-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091416",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.",
"Description": "Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate."
},
{
"NDCCode": "25000-139-14",
"PackageDescription": "1000 TABLET in 1 BOTTLE (25000-139-14) ",
"NDC11Code": "25000-0139-14",
"ProductNDC": "25000-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091416",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.",
"Description": "Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate."
},
{
"NDCCode": "25000-139-22",
"PackageDescription": "4 BAG in 1 BOX (25000-139-22) / 4500 TABLET in 1 BAG",
"NDC11Code": "25000-0139-22",
"ProductNDC": "25000-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091416",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.",
"Description": "Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate."
},
{
"NDCCode": "25000-139-32",
"PackageDescription": "6 BAG in 1 BOX (25000-139-32) / 4500 TABLET in 1 BAG",
"NDC11Code": "25000-0139-32",
"ProductNDC": "25000-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091416",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.",
"Description": "Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate."
},
{
"NDCCode": "25000-139-98",
"PackageDescription": "1 BAG in 1 BOX (25000-139-98) / 25300 TABLET in 1 BAG",
"NDC11Code": "25000-0139-98",
"ProductNDC": "25000-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091416",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110228",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.",
"Description": "Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate."
},
{
"NDCCode": "37205-139-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (37205-139-05) > 15 mL in 1 BOTTLE",
"NDC11Code": "37205-0139-05",
"ProductNDC": "37205-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Original Formula",
"NonProprietaryName": "Tetrahydrozoline Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20120104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "CARDINAL HEALTH",
"SubstanceName": "TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-11-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "43598-127-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (43598-127-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-127-45) ",
"NDC11Code": "43598-0127-25",
"ProductNDC": "43598-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone Sodium Succinate",
"NonProprietaryName": "Methylprednisolone Sodium Succinate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212396",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220324",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
},
{
"NDCCode": "43598-128-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (43598-128-11) / 8 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "43598-0128-11",
"ProductNDC": "43598-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone Sodium Succinate",
"NonProprietaryName": "Methylprednisolone Sodium Succinate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212396",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/8mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220324",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
},
{
"NDCCode": "43598-129-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (43598-129-25) / 2 mL in 1 VIAL, SINGLE-DOSE (43598-129-01) ",
"NDC11Code": "43598-0129-25",
"ProductNDC": "43598-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone Sodium Succinate",
"NonProprietaryName": "Methylprednisolone Sodium Succinate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212396",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"StrengthNumber": "125",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-19",
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"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
},
{
"NDCCode": "43598-130-74",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (43598-130-74) / 16 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "43598-0130-74",
"ProductNDC": "43598-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone Sodium Succinate",
"NonProprietaryName": "Methylprednisolone Sodium Succinate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212396",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "METHYLPREDNISOLONE SODIUM SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "g/16mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220324",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8."
},
{
"NDCCode": "55292-139-01",
"PackageDescription": "1 KIT in 1 KIT (55292-139-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-134-01) * 2 mL in 1 SYRINGE",
"NDC11Code": "55292-0139-01",
"ProductNDC": "55292-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Signifor Lar",
"NonProprietaryName": "Pasireotide",
"DosageFormName": "KIT",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203255",
"LabelerName": "Recordati Rare Diseases, Inc.",
"Status": "Active",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180629",
"SamplePackage": "N",
"IndicationAndUsage": "SIGNIFOR LAR is a somatostatin analog indicated for the treatment of: 1 Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. (1.1), 2 Patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. (1.2).",
"Description": "SIGNIFOR LAR (pasireotide) for injectable suspension is a long-acting release form of pasireotide pamoate, as powder to be suspended in the provided diluent immediately prior to intramuscular injection. SIGNIFOR LAR contains pasireotide, a somatostatin analog in the form of pasireotide pamoate (pamoic acid salt). Pasireotide is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Pasireotide pamoate has a chemical name of (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester pamoic acid salt. The molecular formula of pasireotide pamoate is C58H66N10O9 C23H16O6 and the molecular weight is 1435.58 g/mol. The structural formula is. The drug product consists of pasireotide pamoate uniformly distributed within microspheres which are made of biodegradable copolymers of poly (D,L-lactide-co-glycolide) acids (PLGA). SIGNIFOR LAR is available in a vial containing the sterile pasireotide pamoate, PLGA microspheres powder, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg to be reconstituted with the provided 2 mL sterile diluent. Each vial contains. Each diluent prefilled syringe contains:."
},
{
"NDCCode": "63517-200-21",
"PackageDescription": "139 g in 1 BAG (63517-200-21) ",
"NDC11Code": "63517-0200-21",
"ProductNDC": "63517-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cardinalhealth Antibacterial Bathing Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131003",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Cardinal Health 200, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".12",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20131003",
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},
{
"NDCCode": "65841-139-12",
"PackageDescription": "1 POUCH in 1 DRUM (65841-139-12) / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 1 BAG in 1 BAG / 10 kg in 1 BAG",
"NDC11Code": "65841-0139-12",
"ProductNDC": "65841-139",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180111",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-09-19",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "11-JAN-18"
},
{
"NDCCode": "70692-139-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (70692-139-14) ",
"NDC11Code": "70692-0139-14",
"ProductNDC": "70692-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209274",
"LabelerName": "Strive Pharmaceuticals Inc",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2020-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "71052-139-01",
"PackageDescription": "1 g in 1 CONTAINER (71052-139-01) ",
"NDC11Code": "71052-0139-01",
"ProductNDC": "71052-139",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oxytocin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20191015",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DARMERICA, LLC",
"SubstanceName": "OXYTOCIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "15-OCT-19"
},
{
"NDCCode": "71052-139-50",
"PackageDescription": ".5 g in 1 CONTAINER (71052-139-50) ",
"NDC11Code": "71052-0139-50",
"ProductNDC": "71052-139",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oxytocin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20191015",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DARMERICA, LLC",
"SubstanceName": "OXYTOCIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "15-OCT-19"
},
{
"NDCCode": "71161-131-09",
"PackageDescription": "1 KIT in 1 CARTON (71161-131-09) * 1 SYRINGE in 1 POUCH / 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (71161-139-02) / 1 mL in 1 SYRINGE (71161-139-05) ",
"NDC11Code": "71161-0131-09",
"ProductNDC": "71161-131",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Risperidone",
"DosageFormName": "KIT",
"StartMarketingDate": "20181109",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Synergy Health AST, LLC",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "12-FEB-19"
},
{
"NDCCode": "72789-139-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (72789-139-01) ",
"NDC11Code": "72789-0139-01",
"ProductNDC": "72789-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075388",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201106",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5-mg and 10-mg tablets are scored so they can be bisected. Thus, the 5-mg tablet can also provide a 2.5-mg dose, and the 10-mg tablet can provide a 5-mg dose. The 15-mg and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A)."
},
{
"NDCCode": "72789-139-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-139-60) ",
"NDC11Code": "72789-0139-60",
"ProductNDC": "72789-139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075388",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260224",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5-mg and 10-mg tablets are scored so they can be bisected. Thus, the 5-mg tablet can also provide a 2.5-mg dose, and the 10-mg tablet can provide a 5-mg dose. The 15-mg and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A)."
},
{
"NDCCode": "76891-139-11",
"PackageDescription": "30 mL in 1 BOTTLE (76891-139-11) ",
"NDC11Code": "76891-0139-11",
"ProductNDC": "76891-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "Lush Aloe",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241015",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "SCENT THEORY PRODUCTS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"SamplePackage": "N",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Kojia Acid Power Lifting Cream",
"NonProprietaryName": "Trstay Kojia Acid Power Lifting Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
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"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E - Commerce Co., Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
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"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
}
]
}
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<IndicationAndUsage> To decrease bacteria on the skin that could cause disease. When water, soap and towel are not available. Recommended for repeated use.</IndicationAndUsage>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077056</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
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<LastUpdate>2017-03-10</LastUpdate>
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<NDCCode>68703-139-29</NDCCode>
<PackageDescription>19 g in 1 BOTTLE, GLASS (68703-139-29)</PackageDescription>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Silver Star Brands, Inc</LabelerName>
<SubstanceName>CHIMAPHILA UMBELLATA; CLEMATIS VIRGINIANA TOP; CONIUM MACULATUM FLOWERING TOP; PIPER CUBEBA FRUIT; SAW PALMETTO</SubstanceName>
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<StrengthUnit>[hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_C]/19g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Limitations of Use: 1 Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.</IndicationAndUsage>
<Description>Deferiprone tablets contain 1,000 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C7H9NO2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula. Deferiprone is a white crystalline powder. It is slightly soluble in deionized water and has a melting point range of 271°C - 273°C. Deferiprone Tablets (three times a day), 1,000 mg. Deferiprone tablets, 1,000 mg are white to off-white, modified capsule shaped, biconvex, film coated tablet, debossed with 54 [score] 23 on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core: methylcellulose, crospovidone, magnesium stearate; Coating: hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10122-100-11</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-100-11) </PackageDescription>
<NDC11Code>10122-0100-11</NDC11Code>
<ProductNDC>10122-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ferriprox</ProprietaryName>
<NonProprietaryName>Deferiprone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021825</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>DEFERIPRONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitations of Use. Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.</IndicationAndUsage>
<Description>FERRIPROX Tablets (deferiprone) contain 1,000 mg or 500 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent. The molecular formula for deferiprone is C7H9NO2 and its molecular weight is 139.15 g/mol. Deferiprone has the following structural formula. Deferiprone is a white to pinkish-white powder. It is sparingly soluble in deionized water (14.3 mg/mL) and has a melting point range of 272 °C - 278 °C. FERRIPROX Tablets (twice a day), 1,000 mg. White to off-white, capsule-shaped tablets, and imprinted with “FPX” score “DR” on one side and “APO” score “1000” on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core - hypromellose acetate succinate, magnesium oxide, colloidal silicon dioxide and magnesium stearate; Coating - triethyl citrate, talc, titanium dioxide, and methacrylic acid and ethyl acrylate copolymer. FERRIPROX Tablets (three times a day), 1,000 mg. White to off-white, capsule-shaped tablets, and imprinted with “APO” score “1000” on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 1,000 mg deferiprone and the following inactive ingredients: Tablet core - methylcellulose, crospovidone, and magnesium stearate; Coating - hypromellose, hydroxypropyl cellulose, macrogol, and titanium dioxide. FERRIPROX Tablets, 500 mg. White to off-white, capsule-shaped tablets, and imprinted with “APO” score “500” on one side and plain on the other. The tablets can be broken in half along the score line. Each tablet contains 500 mg deferiprone and the following inactive ingredients: Tablet core - microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide; Coating - hypromellose, polyethylene glycol, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24979-139-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24979-139-01) </PackageDescription>
<NDC11Code>24979-0139-01</NDC11Code>
<ProductNDC>24979-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215848</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below. Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains FD&C Blue No. 1 Aluminum Lake (2.5 mg tablet), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 5 mg tablets), D&C Red No. 27 Aluminum Lake (5 mg tablet), FD&C Yellow No. 6 Aluminum Lake (10 mg tablet), lactose monohydrate, hypromellos, microcrystalline cellulose, magnesium stearate, polyethylene glycol 3350, polyvinyl alcohol, purified water, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>25000-139-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (25000-139-03) </PackageDescription>
<NDC11Code>25000-0139-03</NDC11Code>
<ProductNDC>25000-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091416</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>375</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>25000-139-14</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (25000-139-14) </PackageDescription>
<NDC11Code>25000-0139-14</NDC11Code>
<ProductNDC>25000-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091416</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>375</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>25000-139-22</NDCCode>
<PackageDescription>4 BAG in 1 BOX (25000-139-22) / 4500 TABLET in 1 BAG</PackageDescription>
<NDC11Code>25000-0139-22</NDC11Code>
<ProductNDC>25000-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091416</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>375</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>25000-139-32</NDCCode>
<PackageDescription>6 BAG in 1 BOX (25000-139-32) / 4500 TABLET in 1 BAG</PackageDescription>
<NDC11Code>25000-0139-32</NDC11Code>
<ProductNDC>25000-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091416</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>375</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>25000-139-98</NDCCode>
<PackageDescription>1 BAG in 1 BOX (25000-139-98) / 25300 TABLET in 1 BAG</PackageDescription>
<NDC11Code>25000-0139-98</NDC11Code>
<ProductNDC>25000-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091416</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>375</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>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for. the relief of the signs and symptoms of. · rheumatoid arthritis. · osteoarthritis. · ankylosing spondylitis. · Polyarticular Juvenile Idiopathic Arthritis. · tendonitis. · bursitis. · acute gout. the management of. · pain. · primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen Tablets, USP is nonsteroidal anti-inflammatory drug productavailable as follows: White tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP has the following structural formula:. Molecular Formula: C14H14O3. MW = 230.26. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.The inactive ingredients in naproxen tablets include: croscarmellose sodium, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>37205-139-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37205-139-05) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0139-05</NDC11Code>
<ProductNDC>37205-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Original Formula</ProprietaryName>
<NonProprietaryName>Tetrahydrozoline Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20120104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>CARDINAL HEALTH</LabelerName>
<SubstanceName>TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43598-127-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (43598-127-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-127-45) </PackageDescription>
<NDC11Code>43598-0127-25</NDC11Code>
<ProductNDC>43598-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylprednisolone Sodium Succinate</ProprietaryName>
<NonProprietaryName>Methylprednisolone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212396</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>METHYLPREDNISOLONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
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<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, theintravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below. Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly. Methylprednisolone sodium succinate for injection, USP is available in following strengths for intravenous or intramuscular administration. 40 mg (Single- Dose Vial) Each mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 40 mg methylprednisolone, also 1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium phosphate dried; and 25mg lactose hydrous. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.125 mg (Single- Dose Vial) Each 2 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. This package does not contain diluent. The recommended diluents are Water for Injection USP or Bacteriostatic water for Injection USP. Bacteriostatic Water for Injection USP contains benzyl alcohol as a preservative.500mg (Multi-Dose) Each 8 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 500 mg methylprednisolone; also 6.4 mg monobasic sodium phosphate anhydrous; 69.6 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. 1 gram (Multi-Dose) Each 16 mL (when mixed as directed) contains methylprednisolone sodium succinate equivalent to 1 gram methylprednisolone; also 12.8 mg monobasic sodium phosphate anhydrous; 139.2 mg dibasic sodium phosphate dried.This package does not contain diluent. Recommended diluent Bacteriostatic water for Injection contains benzyl alcohol as a preservative. IMPORTANT – Use only Water for Injection or Bacteriostatic Water for Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection, USP. Use within 48 hours after mixing.When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.</Description>
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<ProprietaryName>Signifor Lar</ProprietaryName>
<NonProprietaryName>Pasireotide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Recordati Rare Diseases, Inc.</LabelerName>
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<IndicationAndUsage>SIGNIFOR LAR is a somatostatin analog indicated for the treatment of: 1 Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. (1.1), 2 Patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. (1.2).</IndicationAndUsage>
<Description>SIGNIFOR LAR (pasireotide) for injectable suspension is a long-acting release form of pasireotide pamoate, as powder to be suspended in the provided diluent immediately prior to intramuscular injection. SIGNIFOR LAR contains pasireotide, a somatostatin analog in the form of pasireotide pamoate (pamoic acid salt). Pasireotide is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Pasireotide pamoate has a chemical name of (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester pamoic acid salt. The molecular formula of pasireotide pamoate is C58H66N10O9 C23H16O6 and the molecular weight is 1435.58 g/mol. The structural formula is. The drug product consists of pasireotide pamoate uniformly distributed within microspheres which are made of biodegradable copolymers of poly (D,L-lactide-co-glycolide) acids (PLGA). SIGNIFOR LAR is available in a vial containing the sterile pasireotide pamoate, PLGA microspheres powder, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg to be reconstituted with the provided 2 mL sterile diluent. Each vial contains. Each diluent prefilled syringe contains:.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2022-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65841-139-12</NDCCode>
<PackageDescription>1 POUCH in 1 DRUM (65841-139-12) / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 1 BAG in 1 BAG / 10 kg in 1 BAG</PackageDescription>
<NDC11Code>65841-0139-12</NDC11Code>
<ProductNDC>65841-139</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180111</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-09-19</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-JAN-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70692-139-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (70692-139-14) </PackageDescription>
<NDC11Code>70692-0139-14</NDC11Code>
<ProductNDC>70692-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209274</ApplicationNumber>
<LabelerName>Strive Pharmaceuticals Inc</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71052-139-01</NDCCode>
<PackageDescription>1 g in 1 CONTAINER (71052-139-01) </PackageDescription>
<NDC11Code>71052-0139-01</NDC11Code>
<ProductNDC>71052-139</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20191015</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DARMERICA, LLC</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-OCT-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71052-139-50</NDCCode>
<PackageDescription>.5 g in 1 CONTAINER (71052-139-50) </PackageDescription>
<NDC11Code>71052-0139-50</NDC11Code>
<ProductNDC>71052-139</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20191015</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DARMERICA, LLC</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-OCT-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71161-131-09</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (71161-131-09) * 1 SYRINGE in 1 POUCH / 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (71161-139-02) / 1 mL in 1 SYRINGE (71161-139-05) </PackageDescription>
<NDC11Code>71161-0131-09</NDC11Code>
<ProductNDC>71161-131</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181109</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Synergy Health AST, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-FEB-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>72789-139-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (72789-139-01) </PackageDescription>
<NDC11Code>72789-0139-01</NDC11Code>
<ProductNDC>72789-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075388</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5-mg and 10-mg tablets are scored so they can be bisected. Thus, the 5-mg tablet can also provide a 2.5-mg dose, and the 10-mg tablet can provide a 5-mg dose. The 15-mg and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A).</Description>
</NDC>
<NDC>
<NDCCode>72789-139-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-139-60) </PackageDescription>
<NDC11Code>72789-0139-60</NDC11Code>
<ProductNDC>72789-139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075388</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: : 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21H 31N 5O 2 HCl is represented by the following structural formula:. Buspirone hydrochloride, USP is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg and 27.4 mg of buspirone free base, respectively). The 5-mg and 10-mg tablets are scored so they can be bisected. Thus, the 5-mg tablet can also provide a 2.5-mg dose, and the 10-mg tablet can provide a 5-mg dose. The 15-mg and 30-mg tablets are provided in the adjustable dosage tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15-mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30-mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride, USP tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (Type A).</Description>
</NDC>
<NDC>
<NDCCode>76891-139-11</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (76891-139-11) </PackageDescription>
<NDC11Code>76891-0139-11</NDC11Code>
<ProductNDC>76891-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>Lush Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>SCENT THEORY PRODUCTS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84515-139-01</NDCCode>
<PackageDescription>50 g in 1 BOX (84515-139-01) </PackageDescription>
<NDC11Code>84515-0139-01</NDC11Code>
<ProductNDC>84515-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Kojia Acid Power Lifting Cream</ProprietaryName>
<NonProprietaryName>Trstay Kojia Acid Power Lifting Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E - Commerce Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
</NDCList>