RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (57 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "0078-0109-01",
      "PackageDescription": "10 AMPULE in 1 BOX (0078-0109-01)  / 5 mL in 1 AMPULE (0078-0109-61) ",
      "NDC11Code": "00078-0109-01",
      "ProductNDC": "0078-0109",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandimmune",
      "NonProprietaryName": "Cyclosporine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19831114",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050573",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "CYCLOSPORINE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19831114",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: 1 Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. , 2 Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. .",
      "Description": "Cyclosporine, the active principle in Sandimmune (cyclosporine capsules) and in Sandimmune (cyclosporine injection) is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl). The chemical structure of cyclosporine (also known as cyclosporin A) is. Sandimmune® (cyclosporine capsules) USP are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains: 1 cyclosporine, USP…………………………………………………………………………………………25 mg, 2 alcohol, USP dehydrated………………………………………………………………max 12.7% by volume."
    },
    {
      "NDCCode": "0009-0078-01",
      "PackageDescription": "1 BAG in 1 DRUM (0009-0078-01)  > 20 kg in 1 BAG",
      "NDC11Code": "00009-0078-01",
      "ProductNDC": "0009-0078",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Progesterone",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19600901",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Pharmacia and Upjohn Company LLC",
      "SubstanceName": "PROGESTERONE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2020-07-31",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "0069-0078-01",
      "PackageDescription": "50 mL in 1 VIAL (0069-0078-01)",
      "NDC11Code": "00069-0078-01",
      "ProductNDC": "0069-0078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Paclitaxel",
      "NonProprietaryName": "Paclitaxel",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20110930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091540",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc.",
      "SubstanceName": "PACLITAXEL",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/50mL",
      "Pharm_Classes": "Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-20",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0078-0180-01",
      "PackageDescription": "10 AMPULE in 1 PACKAGE (0078-0180-01)  / 1 mL in 1 AMPULE (0078-0180-61) ",
      "NDC11Code": "00078-0180-01",
      "ProductNDC": "0078-0180",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19881021",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019667",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "OCTREOTIDE ACETATE",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19881021",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sandostatin Injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).",
      "Description": "Sandostatin Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Sandostatin Injection is available as sterile 1-mL ampuls in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate). Each ampul also contains lactic acid, USP (3.4 mg), mannitol, USP (45 mg), sodium bicarbonate, USP (quantity sufficient to pH 4.2 ± 0.3), water for injection, USP (quantity sufficient to 1 mL). Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is."
    },
    {
      "NDCCode": "0078-0181-01",
      "PackageDescription": "10 AMPULE in 1 PACKAGE (0078-0181-01)  / 1 mL in 1 AMPULE (0078-0181-61) ",
      "NDC11Code": "00078-0181-01",
      "ProductNDC": "0078-0181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19881021",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019667",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "OCTREOTIDE ACETATE",
      "StrengthNumber": "100",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19881021",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sandostatin Injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).",
      "Description": "Sandostatin Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Sandostatin Injection is available as sterile 1-mL ampuls in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate). Each ampul also contains lactic acid, USP (3.4 mg), mannitol, USP (45 mg), sodium bicarbonate, USP (quantity sufficient to pH 4.2 ± 0.3), water for injection, USP (quantity sufficient to 1 mL). Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is."
    },
    {
      "NDCCode": "0078-0182-01",
      "PackageDescription": "10 AMPULE in 1 PACKAGE (0078-0182-01)  / 1 mL in 1 AMPULE (0078-0182-61) ",
      "NDC11Code": "00078-0182-01",
      "ProductNDC": "0078-0182",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandostatin",
      "NonProprietaryName": "Octreotide Acetate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19881021",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019667",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "OCTREOTIDE ACETATE",
      "StrengthNumber": "500",
      "StrengthUnit": "ug/mL",
      "Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19881021",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sandostatin Injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).",
      "Description": "Sandostatin Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Sandostatin Injection is available as sterile 1-mL ampuls in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate). Each ampul also contains lactic acid, USP (3.4 mg), mannitol, USP (45 mg), sodium bicarbonate, USP (quantity sufficient to pH 4.2 ± 0.3), water for injection, USP (quantity sufficient to 1 mL). Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is."
    },
    {
      "NDCCode": "0078-0400-01",
      "PackageDescription": "10 AMPULE in 1 CARTON (0078-0400-01)  > 5 mL in 1 AMPULE (0078-0400-61) ",
      "NDC11Code": "00078-0400-01",
      "ProductNDC": "0078-0400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lopressor",
      "NonProprietaryName": "Metoprolol Tartrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19780115",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018704",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "METOPROLOL TARTRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "19780115",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0672-01",
      "PackageDescription": "10 CAPSULE in 1 BOTTLE (0078-0672-01) ",
      "NDC11Code": "00078-0672-01",
      "ProductNDC": "0078-0672",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hycamtin",
      "NonProprietaryName": "Topotecan",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170707",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020981",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "TOPOTECAN HYDROCHLORIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170707",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "HYCAMTIN® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.",
      "Description": "Topotecan is a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7] indolizino [1,2-b]quinoline-3,14-(4H,12H)-dione monohydrochloride. The molecular formula is C23H23N3O5HCl and the molecular weight is 457.9 g/mol. It is soluble in water and melts with decomposition at 213°C to 218°C. Topotecan hydrochloride has the following structural formula. HYCAMTIN capsules, contain topotecan hydrochloride, the content of which is expressed as topotecan free base. Each 0.25 mg and 1 mg capsule contain topotecan hydrochloride equivalent to 0.25 mg and 1 mg topotecan free-base, respectively. The excipients are gelatin, glyceryl monostearate, hydrogenated vegetable oil, and titanium dioxide. The capsules are imprinted with edible black ink. The 1 mg capsules also contain red iron oxide."
    },
    {
      "NDCCode": "0078-0673-01",
      "PackageDescription": "10 CAPSULE in 1 BOTTLE (0078-0673-01) ",
      "NDC11Code": "00078-0673-01",
      "ProductNDC": "0078-0673",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hycamtin",
      "NonProprietaryName": "Topotecan",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170224",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020981",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "TOPOTECAN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170224",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "HYCAMTIN® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.",
      "Description": "Topotecan is a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7] indolizino [1,2-b]quinoline-3,14-(4H,12H)-dione monohydrochloride. The molecular formula is C23H23N3O5HCl and the molecular weight is 457.9 g/mol. It is soluble in water and melts with decomposition at 213°C to 218°C. Topotecan hydrochloride has the following structural formula. HYCAMTIN capsules, contain topotecan hydrochloride, the content of which is expressed as topotecan free base. Each 0.25 mg and 1 mg capsule contain topotecan hydrochloride equivalent to 0.25 mg and 1 mg topotecan free-base, respectively. The excipients are gelatin, glyceryl monostearate, hydrogenated vegetable oil, and titanium dioxide. The capsules are imprinted with edible black ink. The 1 mg capsules also contain red iron oxide."
    },
    {
      "NDCCode": "0078-0771-01",
      "PackageDescription": "3.5 g in 1 TUBE (0078-0771-01) ",
      "NDC11Code": "00078-0771-01",
      "ProductNDC": "0078-0771",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Maxitrol",
      "NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19720117",
      "EndMarketingDate": "20270228",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050065",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
      "StrengthNumber": "3.5; 10000; 1",
      "StrengthUnit": "mg/g; [USP'U]/g; mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200825",
      "EndMarketingDatePackage": "20270228",
      "SamplePackage": "N",
      "IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.",
      "Description": "MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is. Neomycin B (R1=H, R2=CH2NH2). Neomycin C (R1=CH2NH2, R2=H). The chemical structure for the active ingredient Polymyxin B Sulfate is. The chemical structure for the active ingredient dexamethasone is. C22H29FO5. Molecular Weight = 392.47 g/mol. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains: Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: anhydrous liquid lanolin and white petrolatum."
    },
    {
      "NDCCode": "0078-0813-01",
      "PackageDescription": "3.5 g in 1 TUBE (0078-0813-01) ",
      "NDC11Code": "00078-0813-01",
      "ProductNDC": "0078-0813",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tobrex",
      "NonProprietaryName": "Tobramycin",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19810628",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050555",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "TOBRAMYCIN",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220308",
      "SamplePackage": "N",
      "IndicationAndUsage": "TOBREX® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.",
      "Description": "TOBREX® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each gram of TOBREX (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil, white petrolatum. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. Molecular Formula. C18H37N5O9. Molecular Weight: 467.52 g/mol. Chemical Name. 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine."
    },
    {
      "NDCCode": "0078-0841-01",
      "PackageDescription": "3.5 g in 1 TUBE (0078-0841-01) ",
      "NDC11Code": "00078-0841-01",
      "ProductNDC": "0078-0841",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciloxan",
      "NonProprietaryName": "Ciprofloxacin Hydrochloride",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19980602",
      "EndMarketingDate": "20251031",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020369",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210301",
      "EndMarketingDatePackage": "20251031",
      "SamplePackage": "N",
      "IndicationAndUsage": "CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below. Gram-Positive:Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus Viridans Group. Gram-Negative:Haemophilus influenzae.",
      "Description": "CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 385.82 g/mol. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each gram of CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% contains: Active: ciprofloxacin HCl 3.33 mg equivalent to 3 mg base. Inactives: mineral oil and white petrolatum."
    },
    {
      "NDCCode": "0078-0860-01",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (0078-0860-01)  / 21 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "00078-0860-01",
      "ProductNDC": "0078-0860",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kisqali",
      "NonProprietaryName": "Ribociclib",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170313",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209092",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "RIBOCICLIB SUCCINATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170313",
      "SamplePackage": "N",
      "IndicationAndUsage": "KISQALI is a kinase inhibitor indicated: 1 in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. (1), 2 for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; orfulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. (1).",
      "Description": "KISQALI (ribociclib) is a kinase inhibitor. The chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1/1). Ribociclib succinate is a light yellow to yellowish brown crystalline powder. The molecular formula for ribociclib succinate is C23H30N8O·C4H6O4 and the molecular weight is 552.64 g/mol (Free base: 434.55 g/mol). The chemical structure of ribociclib is shown below. KISQALI film-coated tablets are supplied for oral use and contain 200 mg of ribociclib free base (equivalent to 254.40 mg ribociclib succinate). The tablets also contain colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide, and xanthan gum as inactive ingredients."
    },
    {
      "NDCCode": "0078-0876-01",
      "PackageDescription": "3.5 g in 1 TUBE (0078-0876-01) ",
      "NDC11Code": "00078-0876-01",
      "ProductNDC": "0078-0876",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tobradex",
      "NonProprietaryName": "Tobramycin And Dexamethasone",
      "DosageFormName": "OINTMENT",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "19881015",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050616",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "TOBRAMYCIN; DEXAMETHASONE",
      "StrengthNumber": "3; 1",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20201027",
      "SamplePackage": "N",
      "IndicationAndUsage": "INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens. Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.",
      "Description": "DESCRIPTION: TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below. Each gram of TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil and white petrolatum."
    },
    {
      "NDCCode": "0078-1266-01",
      "PackageDescription": "25000 TABLET, FILM COATED in 1 DRUM (0078-1266-01) ",
      "NDC11Code": "00078-1266-01",
      "ProductNDC": "0078-1266",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Besylate And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20070620",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
      "StrengthNumber": "5; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-18",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20-JUN-07"
    },
    {
      "NDCCode": "0078-1273-01",
      "PackageDescription": "25000 TABLET, FILM COATED in 1 DRUM (0078-1273-01) ",
      "NDC11Code": "00078-1273-01",
      "ProductNDC": "0078-1273",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20090404",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "5; 12.5; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-19",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "04-APR-09"
    },
    {
      "NDCCode": "0078-1280-01",
      "PackageDescription": "25000 TABLET, FILM COATED in 1 DRUM (0078-1280-01) ",
      "NDC11Code": "00078-1280-01",
      "ProductNDC": "0078-1280",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20090404",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "10; 25; 320",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-19",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "04-APR-09"
    },
    {
      "NDCCode": "0078-1287-01",
      "PackageDescription": "25000 TABLET, FILM COATED in 1 DRUM (0078-1287-01) ",
      "NDC11Code": "00078-1287-01",
      "ProductNDC": "0078-1287",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20090404",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "5; 25; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-19",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "04-APR-09"
    },
    {
      "NDCCode": "0078-1294-01",
      "PackageDescription": "25000 TABLET, FILM COATED in 1 DRUM (0078-1294-01) ",
      "NDC11Code": "00078-1294-01",
      "ProductNDC": "0078-1294",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20090404",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "10; 25; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-19",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "04-APR-09"
    },
    {
      "NDCCode": "0078-1301-01",
      "PackageDescription": "25000 TABLET, FILM COATED in 1 DRUM (0078-1301-01) ",
      "NDC11Code": "00078-1301-01",
      "ProductNDC": "0078-1301",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Besylate And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20070620",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
      "StrengthNumber": "5; 320",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-18",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20-JUN-07"
    },
    {
      "NDCCode": "0078-1308-01",
      "PackageDescription": "25000 TABLET, FILM COATED in 1 DRUM (0078-1308-01) ",
      "NDC11Code": "00078-1308-01",
      "ProductNDC": "0078-1308",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Besylate And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20070620",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
      "StrengthNumber": "10; 320",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-18",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20-JUN-07"
    },
    {
      "NDCCode": "0078-1497-01",
      "PackageDescription": "1.5 mL in 1 CARTRIDGE (0078-1497-01) ",
      "NDC11Code": "00078-1497-01",
      "ProductNDC": "0078-1497",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Somatropin",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20060530",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "SOMATROPIN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1.5mL",
      "Status": "Unfinished",
      "LastUpdate": "2025-08-26",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "30-MAY-06"
    },
    {
      "NDCCode": "0078-1504-01",
      "PackageDescription": "60000 TABLET, FILM COATED in 1 DRUM (0078-1504-01) ",
      "NDC11Code": "00078-1504-01",
      "ProductNDC": "0078-1504",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20090404",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "10; 25; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "04-APR-09"
    },
    {
      "NDCCode": "0078-1511-01",
      "PackageDescription": "4.5 kg in 1 BOTTLE (0078-1511-01) ",
      "NDC11Code": "00078-1511-01",
      "ProductNDC": "0078-1511",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tislelizumab",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20240314",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "TISLELIZUMAB",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-18",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "14-MAR-24"
    },
    {
      "NDCCode": "0078-1518-01",
      "PackageDescription": "60000 TABLET, FILM COATED in 1 DRUM (0078-1518-01) ",
      "NDC11Code": "00078-1518-01",
      "ProductNDC": "0078-1518",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "NonProprietaryName": "Amlodipine Valsartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "StartMarketingDate": "20090404",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
      "StrengthNumber": "10; 12.5; 160",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-19",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "04-APR-09"
    },
    {
      "NDCCode": "0132-0078-01",
      "PackageDescription": "230 mL in 1 BOTTLE, WITH APPLICATOR (0132-0078-01) ",
      "NDC11Code": "00132-0078-01",
      "ProductNDC": "0132-0078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fleet",
      "NonProprietaryName": "Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic",
      "DosageFormName": "ENEMA",
      "RouteName": "RECTAL",
      "StartMarketingDate": "20040625",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M007",
      "LabelerName": "C.B. Fleet Company, Inc.",
      "SubstanceName": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC",
      "StrengthNumber": "7; 19",
      "StrengthUnit": "g/230mL; g/230mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20040625",
      "SamplePackage": "N",
      "IndicationAndUsage": "for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes."
    },
    {
      "NDCCode": "0280-0078-01",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (0280-0078-01)  / 4 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00280-0078-01",
      "ProductNDC": "0280-0078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Midol Complete Caffeine Free",
      "NonProprietaryName": "Acetaminophen, Caffeine, And Pyrilamine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210129",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M027",
      "LabelerName": "Bayer HealthCare LLC.",
      "SubstanceName": "ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE",
      "StrengthNumber": "500; 25; 15",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Status": "Active",
      "LastUpdate": "2025-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210129",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water-weight gain, 4 headache, 5 backache, 6 muscle aches."
    },
    {
      "NDCCode": "0378-0078-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0078-01) ",
      "NDC11Code": "00378-0078-01",
      "ProductNDC": "0378-0078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carbidopa And Levodopa",
      "NonProprietaryName": "Carbidopa And Levodopa",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110516",
      "EndMarketingDate": "20250630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090324",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "CARBIDOPA; LEVODOPA",
      "StrengthNumber": "10; 100",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110516",
      "EndMarketingDatePackage": "20250630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.",
      "Description": "Carbidopa and Levodopa Tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4H2O and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.2. Levodopa USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Carbidopa and Levodopa Tablets, USP are supplied as tablets in three strengths. Carbidopa and Levodopa Tablets USP, 10 mg/100 mg contains 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and Levodopa Tablets USP, 25 mg/100 mg contains 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and Levodopa Tablets USP, 25 mg/250 mg contains 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 10 mg/100 mg and 25 mg/250 mg tablets contain FD&C Blue No. 2 Aluminum Lake and the 25 mg/100 mg tablets contain D&C Yellow No. 10 Aluminum Lake."
    },
    {
      "NDCCode": "10210-0078-1",
      "PackageDescription": "1 KIT in 1 TRAY (10210-0078-1)  / 1 KIT in 1 KIT *  4.5 g in 1 CYLINDER (10210-0080-1)  *  4.5 g in 1 CYLINDER (10210-0081-1)  *  4.5 g in 1 CYLINDER (10210-0079-1) ",
      "NDC11Code": "10210-0078-01",
      "ProductNDC": "10210-0078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Carmex Daily Care Moisturizing Lip Spf 15 Assorted",
      "NonProprietaryName": "Homosalate, Octocrylene, Octisalate, Avobenzone",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20230101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Carma Laboratories, Inc.",
      "Status": "Active",
      "LastUpdate": "2024-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230101",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection. provides moderate protection against sunburn . if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
    },
    {
      "NDCCode": "10702-078-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (10702-078-01) ",
      "NDC11Code": "10702-0078-01",
      "ProductNDC": "10702-078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phendimetrazine Tartrate",
      "NonProprietaryName": "Phendimetrazine Tartrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091042",
      "LabelerName": "KVK-TECH, INC",
      "SubstanceName": "PHENDIMETRAZINE TARTRATE",
      "StrengthNumber": "35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2024-12-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20100915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.",
      "Description": "Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)- tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each white tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, the following inactive ingredients are present: Colloidal Silicon Dioxide, Lactose Monohydrate, Microcrystalline Cellulose 102, Sodium Starch Glycolate and Stearic Acid. The yellow tablet also contains FD&C Yellow # 5 Aluminum Lake (15-17%). The blue tablet also contains FD&C Blue # 1 Aluminum Lake (11-13%)."
    }
  ]
}
                    

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<NDCList>
  <NDC>
    <NDCCode>0078-0109-01</NDCCode>
    <PackageDescription>10 AMPULE in 1 BOX (0078-0109-01)  / 5 mL in 1 AMPULE (0078-0109-61) </PackageDescription>
    <NDC11Code>00078-0109-01</NDC11Code>
    <ProductNDC>0078-0109</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandimmune</ProprietaryName>
    <NonProprietaryName>Cyclosporine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19831114</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050573</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>CYCLOSPORINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19831114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: 1 Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. , 2 Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. .</IndicationAndUsage>
    <Description>Cyclosporine, the active principle in Sandimmune (cyclosporine capsules) and in Sandimmune (cyclosporine injection) is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine is designated as [R-[R*,R*-(E)]]-cyclic(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl). The chemical structure of cyclosporine (also known as cyclosporin A) is. Sandimmune® (cyclosporine capsules) USP are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains: 1 cyclosporine, USP…………………………………………………………………………………………25 mg, 2 alcohol, USP dehydrated………………………………………………………………max 12.7% by volume.</Description>
  </NDC>
  <NDC>
    <NDCCode>0009-0078-01</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (0009-0078-01)  &gt; 20 kg in 1 BAG</PackageDescription>
    <NDC11Code>00009-0078-01</NDC11Code>
    <ProductNDC>0009-0078</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Progesterone</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19600901</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Pharmacia and Upjohn Company LLC</LabelerName>
    <SubstanceName>PROGESTERONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-07-31</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0069-0078-01</NDCCode>
    <PackageDescription>50 mL in 1 VIAL (0069-0078-01)</PackageDescription>
    <NDC11Code>00069-0078-01</NDC11Code>
    <ProductNDC>0069-0078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Paclitaxel</ProprietaryName>
    <NonProprietaryName>Paclitaxel</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20110930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091540</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc.</LabelerName>
    <SubstanceName>PACLITAXEL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-20</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0078-0180-01</NDCCode>
    <PackageDescription>10 AMPULE in 1 PACKAGE (0078-0180-01)  / 1 mL in 1 AMPULE (0078-0180-61) </PackageDescription>
    <NDC11Code>00078-0180-01</NDC11Code>
    <ProductNDC>0078-0180</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19881021</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019667</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19881021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sandostatin Injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).</IndicationAndUsage>
    <Description>Sandostatin Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Sandostatin Injection is available as sterile 1-mL ampuls in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate). Each ampul also contains lactic acid, USP (3.4 mg), mannitol, USP (45 mg), sodium bicarbonate, USP (quantity sufficient to pH 4.2 ± 0.3), water for injection, USP (quantity sufficient to 1 mL). Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0181-01</NDCCode>
    <PackageDescription>10 AMPULE in 1 PACKAGE (0078-0181-01)  / 1 mL in 1 AMPULE (0078-0181-61) </PackageDescription>
    <NDC11Code>00078-0181-01</NDC11Code>
    <ProductNDC>0078-0181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19881021</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019667</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19881021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sandostatin Injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).</IndicationAndUsage>
    <Description>Sandostatin Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Sandostatin Injection is available as sterile 1-mL ampuls in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate). Each ampul also contains lactic acid, USP (3.4 mg), mannitol, USP (45 mg), sodium bicarbonate, USP (quantity sufficient to pH 4.2 ± 0.3), water for injection, USP (quantity sufficient to 1 mL). Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0182-01</NDCCode>
    <PackageDescription>10 AMPULE in 1 PACKAGE (0078-0182-01)  / 1 mL in 1 AMPULE (0078-0182-61) </PackageDescription>
    <NDC11Code>00078-0182-01</NDC11Code>
    <ProductNDC>0078-0182</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandostatin</ProprietaryName>
    <NonProprietaryName>Octreotide Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19881021</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019667</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19881021</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sandostatin Injection is a somatostatin analogue indicated: 1 Acromegaly: To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1.1), 2 Carcinoid Tumors: For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1.2), 3 Vasoactive Intestinal Peptide Tumors (VIPomas): For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. (1.3).</IndicationAndUsage>
    <Description>Sandostatin Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Sandostatin Injection is available as sterile 1-mL ampuls in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide (as acetate). Each ampul also contains lactic acid, USP (3.4 mg), mannitol, USP (45 mg), sodium bicarbonate, USP (quantity sufficient to pH 4.2 ± 0.3), water for injection, USP (quantity sufficient to 1 mL). Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0400-01</NDCCode>
    <PackageDescription>10 AMPULE in 1 CARTON (0078-0400-01)  &gt; 5 mL in 1 AMPULE (0078-0400-61) </PackageDescription>
    <NDC11Code>00078-0400-01</NDC11Code>
    <ProductNDC>0078-0400</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopressor</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19780115</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018704</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19780115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0672-01</NDCCode>
    <PackageDescription>10 CAPSULE in 1 BOTTLE (0078-0672-01) </PackageDescription>
    <NDC11Code>00078-0672-01</NDC11Code>
    <ProductNDC>0078-0672</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hycamtin</ProprietaryName>
    <NonProprietaryName>Topotecan</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170707</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020981</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>TOPOTECAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170707</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HYCAMTIN® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.</IndicationAndUsage>
    <Description>Topotecan is a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7] indolizino [1,2-b]quinoline-3,14-(4H,12H)-dione monohydrochloride. The molecular formula is C23H23N3O5HCl and the molecular weight is 457.9 g/mol. It is soluble in water and melts with decomposition at 213°C to 218°C. Topotecan hydrochloride has the following structural formula. HYCAMTIN capsules, contain topotecan hydrochloride, the content of which is expressed as topotecan free base. Each 0.25 mg and 1 mg capsule contain topotecan hydrochloride equivalent to 0.25 mg and 1 mg topotecan free-base, respectively. The excipients are gelatin, glyceryl monostearate, hydrogenated vegetable oil, and titanium dioxide. The capsules are imprinted with edible black ink. The 1 mg capsules also contain red iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0673-01</NDCCode>
    <PackageDescription>10 CAPSULE in 1 BOTTLE (0078-0673-01) </PackageDescription>
    <NDC11Code>00078-0673-01</NDC11Code>
    <ProductNDC>0078-0673</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hycamtin</ProprietaryName>
    <NonProprietaryName>Topotecan</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170224</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020981</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>TOPOTECAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170224</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>HYCAMTIN® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.</IndicationAndUsage>
    <Description>Topotecan is a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7] indolizino [1,2-b]quinoline-3,14-(4H,12H)-dione monohydrochloride. The molecular formula is C23H23N3O5HCl and the molecular weight is 457.9 g/mol. It is soluble in water and melts with decomposition at 213°C to 218°C. Topotecan hydrochloride has the following structural formula. HYCAMTIN capsules, contain topotecan hydrochloride, the content of which is expressed as topotecan free base. Each 0.25 mg and 1 mg capsule contain topotecan hydrochloride equivalent to 0.25 mg and 1 mg topotecan free-base, respectively. The excipients are gelatin, glyceryl monostearate, hydrogenated vegetable oil, and titanium dioxide. The capsules are imprinted with edible black ink. The 1 mg capsules also contain red iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0771-01</NDCCode>
    <PackageDescription>3.5 g in 1 TUBE (0078-0771-01) </PackageDescription>
    <NDC11Code>00078-0771-01</NDC11Code>
    <ProductNDC>0078-0771</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Maxitrol</ProprietaryName>
    <NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19720117</StartMarketingDate>
    <EndMarketingDate>20270228</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050065</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE</SubstanceName>
    <StrengthNumber>3.5; 10000; 1</StrengthNumber>
    <StrengthUnit>mg/g; [USP'U]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200825</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
    <Description>MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is. Neomycin B (R1=H, R2=CH2NH2). Neomycin C (R1=CH2NH2, R2=H). The chemical structure for the active ingredient Polymyxin B Sulfate is. The chemical structure for the active ingredient dexamethasone is. C22H29FO5. Molecular Weight = 392.47 g/mol. Established name: dexamethasone. Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains: Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: anhydrous liquid lanolin and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0813-01</NDCCode>
    <PackageDescription>3.5 g in 1 TUBE (0078-0813-01) </PackageDescription>
    <NDC11Code>00078-0813-01</NDC11Code>
    <ProductNDC>0078-0813</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tobrex</ProprietaryName>
    <NonProprietaryName>Tobramycin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19810628</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050555</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>TOBRAMYCIN</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220308</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TOBREX® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.</IndicationAndUsage>
    <Description>TOBREX® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each gram of TOBREX (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil, white petrolatum. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is. Molecular Formula. C18H37N5O9. Molecular Weight: 467.52 g/mol. Chemical Name. 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0841-01</NDCCode>
    <PackageDescription>3.5 g in 1 TUBE (0078-0841-01) </PackageDescription>
    <NDC11Code>00078-0841-01</NDC11Code>
    <ProductNDC>0078-0841</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciloxan</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19980602</StartMarketingDate>
    <EndMarketingDate>20251031</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020369</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210301</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below. Gram-Positive:Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus Viridans Group. Gram-Negative:Haemophilus influenzae.</IndicationAndUsage>
    <Description>CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 385.82 g/mol. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each gram of CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% contains: Active: ciprofloxacin HCl 3.33 mg equivalent to 3 mg base. Inactives: mineral oil and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0860-01</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (0078-0860-01)  / 21 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00078-0860-01</NDC11Code>
    <ProductNDC>0078-0860</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kisqali</ProprietaryName>
    <NonProprietaryName>Ribociclib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170313</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209092</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>RIBOCICLIB SUCCINATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170313</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KISQALI is a kinase inhibitor indicated: 1 in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. (1), 2 for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; orfulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. (1).</IndicationAndUsage>
    <Description>KISQALI (ribociclib) is a kinase inhibitor. The chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1/1). Ribociclib succinate is a light yellow to yellowish brown crystalline powder. The molecular formula for ribociclib succinate is C23H30N8O·C4H6O4 and the molecular weight is 552.64 g/mol (Free base: 434.55 g/mol). The chemical structure of ribociclib is shown below. KISQALI film-coated tablets are supplied for oral use and contain 200 mg of ribociclib free base (equivalent to 254.40 mg ribociclib succinate). The tablets also contain colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide, and xanthan gum as inactive ingredients.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0876-01</NDCCode>
    <PackageDescription>3.5 g in 1 TUBE (0078-0876-01) </PackageDescription>
    <NDC11Code>00078-0876-01</NDC11Code>
    <ProductNDC>0078-0876</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tobradex</ProprietaryName>
    <NonProprietaryName>Tobramycin And Dexamethasone</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19881015</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050616</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>TOBRAMYCIN; DEXAMETHASONE</SubstanceName>
    <StrengthNumber>3; 1</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201027</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS AND USAGE: TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens. Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.</IndicationAndUsage>
    <Description>DESCRIPTION: TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below. Each gram of TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-1266-01</NDCCode>
    <PackageDescription>25000 TABLET, FILM COATED in 1 DRUM (0078-1266-01) </PackageDescription>
    <NDC11Code>00078-1266-01</NDC11Code>
    <ProductNDC>0078-1266</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Besylate And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20070620</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
    <StrengthNumber>5; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-JUN-07</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1273-01</NDCCode>
    <PackageDescription>25000 TABLET, FILM COATED in 1 DRUM (0078-1273-01) </PackageDescription>
    <NDC11Code>00078-1273-01</NDC11Code>
    <ProductNDC>0078-1273</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20090404</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
    <StrengthNumber>5; 12.5; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-APR-09</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1280-01</NDCCode>
    <PackageDescription>25000 TABLET, FILM COATED in 1 DRUM (0078-1280-01) </PackageDescription>
    <NDC11Code>00078-1280-01</NDC11Code>
    <ProductNDC>0078-1280</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20090404</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
    <StrengthNumber>10; 25; 320</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-APR-09</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1287-01</NDCCode>
    <PackageDescription>25000 TABLET, FILM COATED in 1 DRUM (0078-1287-01) </PackageDescription>
    <NDC11Code>00078-1287-01</NDC11Code>
    <ProductNDC>0078-1287</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20090404</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
    <StrengthNumber>5; 25; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-APR-09</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1294-01</NDCCode>
    <PackageDescription>25000 TABLET, FILM COATED in 1 DRUM (0078-1294-01) </PackageDescription>
    <NDC11Code>00078-1294-01</NDC11Code>
    <ProductNDC>0078-1294</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20090404</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
    <StrengthNumber>10; 25; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-APR-09</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1301-01</NDCCode>
    <PackageDescription>25000 TABLET, FILM COATED in 1 DRUM (0078-1301-01) </PackageDescription>
    <NDC11Code>00078-1301-01</NDC11Code>
    <ProductNDC>0078-1301</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Besylate And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20070620</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
    <StrengthNumber>5; 320</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-JUN-07</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1308-01</NDCCode>
    <PackageDescription>25000 TABLET, FILM COATED in 1 DRUM (0078-1308-01) </PackageDescription>
    <NDC11Code>00078-1308-01</NDC11Code>
    <ProductNDC>0078-1308</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Besylate And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20070620</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
    <StrengthNumber>10; 320</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20-JUN-07</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1497-01</NDCCode>
    <PackageDescription>1.5 mL in 1 CARTRIDGE (0078-1497-01) </PackageDescription>
    <NDC11Code>00078-1497-01</NDC11Code>
    <ProductNDC>0078-1497</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Somatropin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20060530</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SOMATROPIN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1.5mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-08-26</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-MAY-06</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1504-01</NDCCode>
    <PackageDescription>60000 TABLET, FILM COATED in 1 DRUM (0078-1504-01) </PackageDescription>
    <NDC11Code>00078-1504-01</NDC11Code>
    <ProductNDC>0078-1504</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20090404</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
    <StrengthNumber>10; 25; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-APR-09</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1511-01</NDCCode>
    <PackageDescription>4.5 kg in 1 BOTTLE (0078-1511-01) </PackageDescription>
    <NDC11Code>00078-1511-01</NDC11Code>
    <ProductNDC>0078-1511</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tislelizumab</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20240314</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>TISLELIZUMAB</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-18</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>14-MAR-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-1518-01</NDCCode>
    <PackageDescription>60000 TABLET, FILM COATED in 1 DRUM (0078-1518-01) </PackageDescription>
    <NDC11Code>00078-1518-01</NDC11Code>
    <ProductNDC>0078-1518</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20090404</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
    <StrengthNumber>10; 12.5; 160</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>04-APR-09</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0132-0078-01</NDCCode>
    <PackageDescription>230 mL in 1 BOTTLE, WITH APPLICATOR (0132-0078-01) </PackageDescription>
    <NDC11Code>00132-0078-01</NDC11Code>
    <ProductNDC>0132-0078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fleet</ProprietaryName>
    <NonProprietaryName>Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic</NonProprietaryName>
    <DosageFormName>ENEMA</DosageFormName>
    <RouteName>RECTAL</RouteName>
    <StartMarketingDate>20040625</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>C.B. Fleet Company, Inc.</LabelerName>
    <SubstanceName>SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC</SubstanceName>
    <StrengthNumber>7; 19</StrengthNumber>
    <StrengthUnit>g/230mL; g/230mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20040625</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0280-0078-01</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (0280-0078-01)  / 4 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00280-0078-01</NDC11Code>
    <ProductNDC>0280-0078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Midol Complete Caffeine Free</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Caffeine, And Pyrilamine Maleate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210129</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M027</ApplicationNumber>
    <LabelerName>Bayer HealthCare LLC.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE</SubstanceName>
    <StrengthNumber>500; 25; 15</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of these symptoms associated with menstrual periods: 1 cramps, 2 bloating, 3 water-weight gain, 4 headache, 5 backache, 6 muscle aches.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0378-0078-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0078-01) </PackageDescription>
    <NDC11Code>00378-0078-01</NDC11Code>
    <ProductNDC>0378-0078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
    <NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110516</StartMarketingDate>
    <EndMarketingDate>20250630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090324</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
    <StrengthNumber>10; 100</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110516</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.</IndicationAndUsage>
    <Description>Carbidopa and Levodopa Tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C10H14N2O4H2O and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.2. Levodopa USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C9H11NO4 and its structural formula is. Carbidopa and Levodopa Tablets, USP are supplied as tablets in three strengths. Carbidopa and Levodopa Tablets USP, 10 mg/100 mg contains 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and Levodopa Tablets USP, 25 mg/100 mg contains 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and Levodopa Tablets USP, 25 mg/250 mg contains 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 10 mg/100 mg and 25 mg/250 mg tablets contain FD&amp;C Blue No. 2 Aluminum Lake and the 25 mg/100 mg tablets contain D&amp;C Yellow No. 10 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>10210-0078-1</NDCCode>
    <PackageDescription>1 KIT in 1 TRAY (10210-0078-1)  / 1 KIT in 1 KIT *  4.5 g in 1 CYLINDER (10210-0080-1)  *  4.5 g in 1 CYLINDER (10210-0081-1)  *  4.5 g in 1 CYLINDER (10210-0079-1) </PackageDescription>
    <NDC11Code>10210-0078-01</NDC11Code>
    <ProductNDC>10210-0078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Carmex Daily Care Moisturizing Lip Spf 15 Assorted</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Octisalate, Avobenzone</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Carma Laboratories, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection. provides moderate protection against sunburn . if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10702-078-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (10702-078-01) </PackageDescription>
    <NDC11Code>10702-0078-01</NDC11Code>
    <ProductNDC>10702-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phendimetrazine Tartrate</ProprietaryName>
    <NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091042</ApplicationNumber>
    <LabelerName>KVK-TECH, INC</LabelerName>
    <SubstanceName>PHENDIMETRAZINE TARTRATE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-12-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. Phendimetrazine tartrate is indicated for use as monotherapy only.</IndicationAndUsage>
    <Description>Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)- tartrate (1:1). The structural formula is. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each white tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, the following inactive ingredients are present: Colloidal Silicon Dioxide, Lactose Monohydrate, Microcrystalline Cellulose 102, Sodium Starch Glycolate and Stearic Acid. The yellow tablet also contains FD&amp;C Yellow # 5 Aluminum Lake (15-17%). The blue tablet also contains FD&amp;C Blue # 1 Aluminum Lake (11-13%).</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0078-0109-01</NDCCode><ProprietaryName>Sandimmune</ProprietaryName><NonProprietaryName>Cyclosporine</NonProprietaryName></NDC><NDC><NDCCode>0009-0078-01</NDCCode><NonProprietaryName>Progesterone</NonProprietaryName></NDC><NDC><NDCCode>0069-0078-01</NDCCode><ProprietaryName>Paclitaxel</ProprietaryName><NonProprietaryName>Paclitaxel</NonProprietaryName></NDC><NDC><NDCCode>0078-0180-01</NDCCode><ProprietaryName>Sandostatin</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0181-01</NDCCode><ProprietaryName>Sandostatin</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0182-01</NDCCode><ProprietaryName>Sandostatin</ProprietaryName><NonProprietaryName>Octreotide Acetate</NonProprietaryName></NDC><NDC><NDCCode>0078-0400-01</NDCCode><ProprietaryName>Lopressor</ProprietaryName><NonProprietaryName>Metoprolol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0078-0672-01</NDCCode><ProprietaryName>Hycamtin</ProprietaryName><NonProprietaryName>Topotecan</NonProprietaryName></NDC><NDC><NDCCode>0078-0673-01</NDCCode><ProprietaryName>Hycamtin</ProprietaryName><NonProprietaryName>Topotecan</NonProprietaryName></NDC><NDC><NDCCode>0078-0771-01</NDCCode><ProprietaryName>Maxitrol</ProprietaryName><NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>0078-0813-01</NDCCode><ProprietaryName>Tobrex</ProprietaryName><NonProprietaryName>Tobramycin</NonProprietaryName></NDC><NDC><NDCCode>0078-0841-01</NDCCode><ProprietaryName>Ciloxan</ProprietaryName><NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0078-0860-01</NDCCode><ProprietaryName>Kisqali</ProprietaryName><NonProprietaryName>Ribociclib</NonProprietaryName></NDC><NDC><NDCCode>0078-0876-01</NDCCode><ProprietaryName>Tobradex</ProprietaryName><NonProprietaryName>Tobramycin And Dexamethasone</NonProprietaryName></NDC><NDC><NDCCode>0078-1266-01</NDCCode><NonProprietaryName>Amlodipine Besylate And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>0078-1273-01</NDCCode><NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0078-1280-01</NDCCode><NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0078-1287-01</NDCCode><NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0078-1294-01</NDCCode><NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0078-1301-01</NDCCode><NonProprietaryName>Amlodipine Besylate And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>0078-1308-01</NDCCode><NonProprietaryName>Amlodipine Besylate And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>0078-1497-01</NDCCode><NonProprietaryName>Somatropin</NonProprietaryName></NDC><NDC><NDCCode>0078-1504-01</NDCCode><NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0078-1511-01</NDCCode><NonProprietaryName>Tislelizumab</NonProprietaryName></NDC><NDC><NDCCode>0078-1518-01</NDCCode><NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>0132-0078-01</NDCCode><ProprietaryName>Fleet</ProprietaryName><NonProprietaryName>Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic</NonProprietaryName></NDC><NDC><NDCCode>0280-0078-01</NDCCode><ProprietaryName>Midol Complete Caffeine Free</ProprietaryName><NonProprietaryName>Acetaminophen, Caffeine, And Pyrilamine Maleate</NonProprietaryName></NDC><NDC><NDCCode>0378-0078-01</NDCCode><ProprietaryName>Carbidopa And Levodopa</ProprietaryName><NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName></NDC><NDC><NDCCode>10210-0078-1</NDCCode><ProprietaryName>Carmex Daily Care Moisturizing Lip Spf 15 Assorted</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Octisalate, Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>10702-078-01</NDCCode><ProprietaryName>Phendimetrazine Tartrate</ProprietaryName><NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
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      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
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}
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