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How to Find 0078-9777-50 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "0078-9777-50",
      "PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (0078-9777-50) ",
      "NDC11Code": "00078-9777-50",
      "ProductNDC": "0078-9777",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Entresto",
      "NonProprietaryName": "Sacubitril And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150707",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207620",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "SACUBITRIL; VALSARTAN",
      "StrengthNumber": "49; 51",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180823",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .",
      "Description": "ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide."
    },
    {
      "NDCCode": "0143-9777-50",
      "PackageDescription": "50 TABLET in 1 BOTTLE (0143-9777-50)",
      "NDC11Code": "00143-9777-50",
      "ProductNDC": "0143-9777",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078767",
      "LabelerName": "West-ward Pharmaceutical Corp",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "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": "0078-0110-22",
      "PackageDescription": "50 mL in 1 BOTTLE (0078-0110-22) ",
      "NDC11Code": "00078-0110-22",
      "ProductNDC": "0078-0110",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sandimmune",
      "NonProprietaryName": "Cyclosporine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19831114",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050574",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "CYCLOSPORINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19831114",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sandimmune (cyclosporine) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, Sandimmune Injection (cyclosporine injection, USP) should be reserved for patients who are unable to take the soft gelatin capsules or oral solution.",
      "Description": "Cyclosporine, the active principle in Sandimmune (cyclosporine) 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). Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains. cyclosporine, USP…………………………………………………………………………………………25 mg. alcohol, USP dehydrated………………………………………………………………max 12.7% by volume. Each 100 mg capsule contains. cyclosporine, USP……………………………………………………………………………………….100 mg. alcohol, USP dehydrated………………………………………………………………max 12.7% by volume. Inactive ingredients: corn oil, gelatin, iron oxide red, linoleoyl macrogolglycerides, sorbitol, and titanium dioxide. May also contain glycerol. 100 mg capsules may contain iron oxide yellow. Sandimmune® Oral Solution (cyclosporine oral solution, USP) is available in 50 mL bottles. Each mL contains. cyclosporine, USP……………………………………………………………………………………….100 mg. alcohol, Ph. Helv. ……………………………………………………………………………12.5% by volume. dissolved in an olive oil, Ph. Helv./Labrafil M 1944 CS (polyoxyethylated oleic glycerides) vehicle which must be further diluted with milk, chocolate milk, or orange juice before oral administration. Sandimmune® Injection (cyclosporine injection, USP) is available in a 5 mL sterile ampul for intravenous (IV) administration. Each mL contains. cyclosporine, USP…………………………………………………………………………………………50 mg. *Cremophor® EL (polyoxyethylated castor oil)………………………………………………………..650 mg. alcohol, Ph. Helv. ……………………………………………………………………………32.9% by volume. nitrogen………………………………………………………………………………………………………….qs. which must be diluted further with 0.9% Sodium Chloride Injection or 5% Dextrose Injection using appropriate aseptic technique before use. The chemical structure of cyclosporine (also known as cyclosporin A) is."
    },
    {
      "NDCCode": "0078-0274-22",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0078-0274-22)  / 50 mL in 1 BOTTLE",
      "NDC11Code": "00078-0274-22",
      "ProductNDC": "0078-0274",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Neoral",
      "NonProprietaryName": "Cyclosporine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950714",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050716",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "CYCLOSPORINE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950714",
      "SamplePackage": "N",
      "IndicationAndUsage": "Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids.",
      "Description": "Neoral is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active principle in Neoral, 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)."
    },
    {
      "NDCCode": "0078-0368-64",
      "PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0368-64)  > 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0368-61)",
      "NDC11Code": "00078-0368-64",
      "ProductNDC": "0078-0368",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Famvir",
      "NonProprietaryName": "Famciclovir",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940629",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020363",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "FAMCICLOVIR",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-26"
    },
    {
      "NDCCode": "0078-0683-06",
      "PackageDescription": "6 VIAL in 1 CARTON (0078-0683-06)  > 50 mL in 1 VIAL",
      "NDC11Code": "00078-0683-06",
      "ProductNDC": "0078-0683",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arranon",
      "NonProprietaryName": "Nelarabine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20161005",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021877",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "NELARABINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-09-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20161005",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0078-0683-61",
      "PackageDescription": "50 mL in 1 VIAL (0078-0683-61) ",
      "NDC11Code": "00078-0683-61",
      "ProductNDC": "0078-0683",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arranon",
      "NonProprietaryName": "Nelarabine",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20161005",
      "EndMarketingDate": "20260930",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021877",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "NELARABINE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190802",
      "EndMarketingDatePackage": "20260930",
      "SamplePackage": "N",
      "IndicationAndUsage": "ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.",
      "Description": "ARRANON (nelarabine) is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β-D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β-D-arabinofuranosyl-6-methoxy-9H-purine. It has the molecular formula C11H15N5O5 and a molecular weight of 297.27. Nelarabine has the following structural formula. Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209ºC and 217ºC. ARRANON (nelarabine) injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in Water for Injection, USP. ARRANON is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0."
    },
    {
      "NDCCode": "0078-0690-61",
      "PackageDescription": "50 mL in 1 VIAL, SINGLE-USE (0078-0690-61) ",
      "NDC11Code": "00078-0690-61",
      "ProductNDC": "0078-0690",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Arzerra",
      "NonProprietaryName": "Ofatumumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20160201",
      "EndMarketingDate": "20260331",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125326",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "OFATUMUMAB",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160201",
      "EndMarketingDatePackage": "20260331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Chronic Lymphocytic Leukemia (CLL). ARZERRA (ofatumumab) is indicated: : 1 in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)], 2 in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)], 3 for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)], 4 for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)].",
      "Description": "ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa. The antibody was generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line (NS0) using standard mammalian cell cultivation and purification technologies. ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate for intravenous administration. ARZERRA is supplied at a concentration of 20 mg/mL in single-use vials. Each single-use vial contains either 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution. Inactive ingredients include: 10 mg/mL arginine, diluted hydrochloric acid, 0.019 mg/mL edetate disodium, 0.2 mg/mL polysorbate 80, 6.8 mg/mL sodium acetate, 2.98 mg/mL sodium chloride, and Water for Injection, USP. The pH is 5.5."
    },
    {
      "NDCCode": "0078-0909-61",
      "PackageDescription": "1 KIT in 1 KIT (0078-0909-61)  *  28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50)  *  21 TABLET in 1 BLISTER PACK (0078-0888-21) ",
      "NDC11Code": "00078-0909-61",
      "ProductNDC": "0078-0909",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kisqali Femara Co-pack",
      "NonProprietaryName": "Letrozole And Ribociclib",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170504",
      "EndMarketingDate": "20260831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209935",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170504",
      "EndMarketingDatePackage": "20260831",
      "SamplePackage": "N",
      "IndicationAndUsage": "KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated: 1 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 as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer therapy. (1).",
      "Description": "KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film-coated tablets co-packaged with letrozole 2.5 mg tablets. Ribociclib. KISQALI (ribociclib) is a kinase inhibitor. Ribociclib succinate is a light yellow to yellowish brown crystalline powder. 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). 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 hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients. Letrozole. FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is. FEMARA is available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0078-0916-61",
      "PackageDescription": "1 KIT in 1 KIT (0078-0916-61)  *  28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50)  *  14 TABLET in 1 BLISTER PACK (0078-0895-14) ",
      "NDC11Code": "00078-0916-61",
      "ProductNDC": "0078-0916",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kisqali Femara Co-pack",
      "NonProprietaryName": "Letrozole And Ribociclib",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170504",
      "EndMarketingDate": "20260831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209935",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170504",
      "EndMarketingDatePackage": "20260831",
      "SamplePackage": "N",
      "IndicationAndUsage": "KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated: 1 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 as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer therapy. (1).",
      "Description": "KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film-coated tablets co-packaged with letrozole 2.5 mg tablets. Ribociclib. KISQALI (ribociclib) is a kinase inhibitor. Ribociclib succinate is a light yellow to yellowish brown crystalline powder. 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). 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 hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients. Letrozole. FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is. FEMARA is available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0078-0923-61",
      "PackageDescription": "1 KIT in 1 KIT (0078-0923-61)  *  28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50)  *  21 TABLET in 1 BLISTER PACK (0078-0902-21) ",
      "NDC11Code": "00078-0923-61",
      "ProductNDC": "0078-0923",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kisqali Femara Co-pack",
      "NonProprietaryName": "Letrozole And Ribociclib",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170504",
      "EndMarketingDate": "20260831",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209935",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2026-09-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170504",
      "EndMarketingDatePackage": "20260831",
      "SamplePackage": "N",
      "IndicationAndUsage": "KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated: 1 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 as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer therapy. (1).",
      "Description": "KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film-coated tablets co-packaged with letrozole 2.5 mg tablets. Ribociclib. KISQALI (ribociclib) is a kinase inhibitor. Ribociclib succinate is a light yellow to yellowish brown crystalline powder. 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). 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 hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients. Letrozole. FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is. FEMARA is available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "0078-0979-50",
      "PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-50) ",
      "NDC11Code": "00078-0979-50",
      "ProductNDC": "0078-0979",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mayzent",
      "NonProprietaryName": "Siponimod",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190326",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209884",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "SIPONIMOD",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190326",
      "SamplePackage": "N",
      "IndicationAndUsage": "MAYZENT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
      "Description": "MAYZENT tablets contains siponimod, an S1P receptor modulator, as 2:1 co-crystal of siponimod and fumaric acid and has the following chemical name. 1-[[4-[(1E)-1-[[[4-Cyclohexyl-3-(trifluoromethyl)phenyl]methoxy]imino]ethyl]-2-ethylphenyl]methyl]-3-azetidinecarboxylic acid (2E)-2-butenedioate (2:1). Its molecular formula is C4H4O42C29H35F3N2O3, and its molecular weight is 1149.29 g/mol. Its structure is shown below. It is a white to almost white powder. MAYZENT is provided as 0.25 mg, 1 mg, and 2 mg film-coated tablets for oral use. Each tablet contains 0.25 mg, 1 mg, or 2 mg siponimod, equivalent to 0.28 mg, 1.11 mg, or 2.22 mg as 2:1 co-crystal of siponimod and fumaric acid, respectively. MAYZENT tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl dibehenate, lactose monohydrate, microcrystalline cellulose, with a film coating containing iron oxides (black and red iron oxides for the 0.25 mg and 1 mg strengths and red and yellow iron oxides for the 2 mg strength), lecithin (soy), polyvinyl alcohol, talc, titanium dioxide, and xanthan gum."
    },
    {
      "NDCCode": "0078-9659-50",
      "PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (0078-9659-50) ",
      "NDC11Code": "00078-9659-50",
      "ProductNDC": "0078-9659",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Entresto",
      "NonProprietaryName": "Sacubitril And Valsartan",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150707",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207620",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "SACUBITRIL; VALSARTAN",
      "StrengthNumber": "24; 26",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180823",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .",
      "Description": "ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide."
    },
    {
      "NDCCode": "14501-0078-2",
      "PackageDescription": "50 kg in 1 DRUM (14501-0078-2) ",
      "NDC11Code": "14501-0078-02",
      "ProductNDC": "14501-0078",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Roflumilast",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120322",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "MSN Laboratories Private Limited",
      "SubstanceName": "ROFLUMILAST",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-23",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "22-MAR-12"
    },
    {
      "NDCCode": "37000-078-50",
      "PackageDescription": "50 mL in 1 BOTTLE, PLASTIC (37000-078-50)",
      "NDC11Code": "37000-0078-50",
      "ProductNDC": "37000-078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Head And Shoulders",
      "ProprietaryNameSuffix": "Green Apple 2in1",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "LOTION/SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130901",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "Procter & Gamble Manufacturing Co.",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-11-18"
    },
    {
      "NDCCode": "37012-078-50",
      "PackageDescription": "50 TABLET in 1 BOTTLE, PLASTIC (37012-078-50)",
      "NDC11Code": "37012-0078-50",
      "ProductNDC": "37012-078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Shopko Chest Congestion Relief Dmtdm",
      "ProprietaryNameSuffix": "Tdm",
      "NonProprietaryName": "Dextromethorphan Hydrobromide / Guaifenesin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120801",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Shopko",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
      "StrengthNumber": "20; 400",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus■ Helps make coughs more productive."
    },
    {
      "NDCCode": "48087-0078-0",
      "PackageDescription": "50 kg in 1 DRUM (48087-0078-0) ",
      "NDC11Code": "48087-0078-00",
      "ProductNDC": "48087-0078",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sitagliptin Phosphate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20100412",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.",
      "SubstanceName": "SITAGLIPTIN PHOSPHATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2021-12-18",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "12-APR-10"
    },
    {
      "NDCCode": "49288-0078-5",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0078-5)",
      "NDC11Code": "49288-0078-05",
      "ProductNDC": "49288-0078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Red (river) Birch",
      "NonProprietaryName": "Red (river) Birch",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19740323",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "BETULA NIGRA POLLEN",
      "StrengthNumber": ".05",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
      "Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
    },
    {
      "NDCCode": "57237-078-50",
      "PackageDescription": "500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-50) ",
      "NDC11Code": "57237-0078-50",
      "ProductNDC": "57237-078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100412",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090469",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "ONDANSETRON",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-08-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy, 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
      "Description": "The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula: The molecular formula is C18H19N3O representing a molecular weight of 293.4 g/mol. Ondansetron is a white to off-white powder. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing. Meets USP Disintegration Test 2."
    },
    {
      "NDCCode": "62350-0078-6",
      "PackageDescription": "50 kg in 1 DRUM (62350-0078-6) ",
      "NDC11Code": "62350-0078-06",
      "ProductNDC": "62350-0078",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Docusate Sodium/sodium Benzoate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20170519",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Wanbury Limited",
      "SubstanceName": "DOCUSATE SODIUM/SODIUM BENZOATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-06",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "19-MAY-17"
    },
    {
      "NDCCode": "65862-078-50",
      "PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (65862-078-50) ",
      "NDC11Code": "65862-0078-50",
      "ProductNDC": "65862-078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070426",
      "EndMarketingDate": "20270131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077859",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
      "Status": "Active",
      "LastUpdate": "2025-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20070426",
      "EndMarketingDatePackage": "20270131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
      "Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3­-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "65977-0078-1",
      "PackageDescription": "50 kg in 1 DRUM (65977-0078-1) ",
      "NDC11Code": "65977-0078-01",
      "ProductNDC": "65977-0078",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Sevelamer Carbonate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20071019",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Hetero Drugs Limited",
      "SubstanceName": "SEVELAMER CARBONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-01-01",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "19-OCT-07"
    },
    {
      "NDCCode": "66174-0078-0",
      "PackageDescription": "50 kg in 1 DRUM (66174-0078-0)",
      "NDC11Code": "66174-0078-00",
      "ProductNDC": "66174-0078",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150223",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Srini Pharmaceuticals Limited",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "66343-078-50",
      "PackageDescription": "50 mL in 1 BOTTLE (66343-078-50) ",
      "NDC11Code": "66343-0078-50",
      "ProductNDC": "66343-078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Geovita",
      "NonProprietaryName": "Cerebrum, Ferrum Met, Silicea, Cuprum Met, Foricum Acidum",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190603",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "RUBIMED AG",
      "SubstanceName": "SUS SCROFA CEREBRUM; IRON; SILICON DIOXIDE; COPPER; FORMIC ACID",
      "StrengthNumber": "21; 6; 12; 21; 21",
      "StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190603",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68225-078-50",
      "PackageDescription": "198 BOX in 1 CONTAINER (68225-078-50)  > 10 VIAL in 1 BOX > 50 mL in 1 VIAL",
      "NDC11Code": "68225-0078-50",
      "ProductNDC": "68225-078",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Iopamidol",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "19851231",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon Italia S.p.A.",
      "SubstanceName": "IOPAMIDOL",
      "StrengthNumber": "755",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2018-02-02",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "71930-078-50",
      "PackageDescription": "50 TABLET in 1 BOTTLE (71930-078-50) ",
      "NDC11Code": "71930-0078-50",
      "ProductNDC": "71930-078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocortisone",
      "NonProprietaryName": "Hydrocortisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217160",
      "LabelerName": "Eywa Pharma Inc",
      "SubstanceName": "HYDROCORTISONE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221007",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocortisone Tablets are indicated in the following conditions.",
      "Description": "Hydrocortisone Tablets, USPcontain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USPare available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP. Inactive ingredients: calcium stearate, corn starch, lactose monohydrate, sorbic acid, sucrose. Meets USP Dissolution Test 2. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli."
    },
    {
      "NDCCode": "75670-003-02",
      "PackageDescription": "24 BAG in 1 CARTON (75670-003-02)  > 50 POUCH in 1 BAG > .0078 g in 1 POUCH",
      "NDC11Code": "75670-0003-02",
      "ProductNDC": "75670-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sanitizing Wipes",
      "NonProprietaryName": "Benzalkonium Chloride,didecyldimonium Chloride",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200609",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD.",
      "SubstanceName": "BENZALKONIUM CHLORIDE; DIDECYLDIMONIUM CHLORIDE",
      "StrengthNumber": ".1; .15",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200609",
      "SamplePackage": "N",
      "IndicationAndUsage": "●For hand sanitizing to decrease bacteria on the skin. ●Apply topically to the skin to help prevent cross contamination. ●Recommended for repeated use. Dries in seconds."
    },
    {
      "NDCCode": "83324-078-50",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (83324-078-50)  / 50 TABLET, COATED in 1 BOTTLE, PLASTIC",
      "NDC11Code": "83324-0078-50",
      "ProductNDC": "83324-078",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pain Relief",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240403",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "CHAIN DRUG MARKETING ASSOCIATION, INC.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240403",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to: the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps. temporarily reduces fever."
    },
    {
      "NDCCode": "87063-078-50",
      "PackageDescription": "50 g in 1 JAR (87063-078-50) ",
      "NDC11Code": "87063-0078-50",
      "ProductNDC": "87063-078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Silver Sulfadiazine",
      "NonProprietaryName": "Silver Sulfadiazine",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19851223",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018810",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "SILVER SULFADIAZINE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260123",
      "SamplePackage": "N",
      "IndicationAndUsage": "Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.",
      "Description": "Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application.  Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula:.      Silver sulfadiazine cream contains 1% w/w silver sulfadiazine.  The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative."
    }
  ]
}
                    
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<NDCList>
  <NDC>
    <NDCCode>0078-9777-50</NDCCode>
    <PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (0078-9777-50) </PackageDescription>
    <NDC11Code>00078-9777-50</NDC11Code>
    <ProductNDC>0078-9777</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Entresto</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150707</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207620</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>49; 51</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180823</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0143-9777-50</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (0143-9777-50)</PackageDescription>
    <NDC11Code>00143-9777-50</NDC11Code>
    <ProductNDC>0143-9777</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110621</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078767</ApplicationNumber>
    <LabelerName>West-ward Pharmaceutical Corp</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</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>0078-0110-22</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (0078-0110-22) </PackageDescription>
    <NDC11Code>00078-0110-22</NDC11Code>
    <ProductNDC>0078-0110</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sandimmune</ProprietaryName>
    <NonProprietaryName>Cyclosporine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19831114</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050574</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>CYCLOSPORINE</SubstanceName>
    <StrengthNumber>100</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>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>19831114</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sandimmune (cyclosporine) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, Sandimmune Injection (cyclosporine injection, USP) should be reserved for patients who are unable to take the soft gelatin capsules or oral solution.</IndicationAndUsage>
    <Description>Cyclosporine, the active principle in Sandimmune (cyclosporine) 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). Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains. cyclosporine, USP…………………………………………………………………………………………25 mg. alcohol, USP dehydrated………………………………………………………………max 12.7% by volume. Each 100 mg capsule contains. cyclosporine, USP……………………………………………………………………………………….100 mg. alcohol, USP dehydrated………………………………………………………………max 12.7% by volume. Inactive ingredients: corn oil, gelatin, iron oxide red, linoleoyl macrogolglycerides, sorbitol, and titanium dioxide. May also contain glycerol. 100 mg capsules may contain iron oxide yellow. Sandimmune® Oral Solution (cyclosporine oral solution, USP) is available in 50 mL bottles. Each mL contains. cyclosporine, USP……………………………………………………………………………………….100 mg. alcohol, Ph. Helv. ……………………………………………………………………………12.5% by volume. dissolved in an olive oil, Ph. Helv./Labrafil M 1944 CS (polyoxyethylated oleic glycerides) vehicle which must be further diluted with milk, chocolate milk, or orange juice before oral administration. Sandimmune® Injection (cyclosporine injection, USP) is available in a 5 mL sterile ampul for intravenous (IV) administration. Each mL contains. cyclosporine, USP…………………………………………………………………………………………50 mg. *Cremophor® EL (polyoxyethylated castor oil)………………………………………………………..650 mg. alcohol, Ph. Helv. ……………………………………………………………………………32.9% by volume. nitrogen………………………………………………………………………………………………………….qs. which must be diluted further with 0.9% Sodium Chloride Injection or 5% Dextrose Injection using appropriate aseptic technique before use. The chemical structure of cyclosporine (also known as cyclosporin A) is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0274-22</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0078-0274-22)  / 50 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00078-0274-22</NDC11Code>
    <ProductNDC>0078-0274</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neoral</ProprietaryName>
    <NonProprietaryName>Cyclosporine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950714</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050716</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>CYCLOSPORINE</SubstanceName>
    <StrengthNumber>100</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>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids.</IndicationAndUsage>
    <Description>Neoral is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active principle in Neoral, 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).</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0368-64</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0368-64)  &gt; 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0368-61)</PackageDescription>
    <NDC11Code>00078-0368-64</NDC11Code>
    <ProductNDC>0078-0368</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famvir</ProprietaryName>
    <NonProprietaryName>Famciclovir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940629</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020363</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>FAMCICLOVIR</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-26</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0078-0683-06</NDCCode>
    <PackageDescription>6 VIAL in 1 CARTON (0078-0683-06)  &gt; 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>00078-0683-06</NDC11Code>
    <ProductNDC>0078-0683</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Arranon</ProprietaryName>
    <NonProprietaryName>Nelarabine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20161005</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021877</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>NELARABINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161005</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0078-0683-61</NDCCode>
    <PackageDescription>50 mL in 1 VIAL (0078-0683-61) </PackageDescription>
    <NDC11Code>00078-0683-61</NDC11Code>
    <ProductNDC>0078-0683</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Arranon</ProprietaryName>
    <NonProprietaryName>Nelarabine</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20161005</StartMarketingDate>
    <EndMarketingDate>20260930</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021877</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>NELARABINE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190802</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.</IndicationAndUsage>
    <Description>ARRANON (nelarabine) is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β-D-arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β-D-arabinofuranosyl-6-methoxy-9H-purine. It has the molecular formula C11H15N5O5 and a molecular weight of 297.27. Nelarabine has the following structural formula. Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209ºC and 217ºC. ARRANON (nelarabine) injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in Water for Injection, USP. ARRANON is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0690-61</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, SINGLE-USE (0078-0690-61) </PackageDescription>
    <NDC11Code>00078-0690-61</NDC11Code>
    <ProductNDC>0078-0690</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Arzerra</ProprietaryName>
    <NonProprietaryName>Ofatumumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20160201</StartMarketingDate>
    <EndMarketingDate>20260331</EndMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125326</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>OFATUMUMAB</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260331</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Chronic Lymphocytic Leukemia (CLL). ARZERRA (ofatumumab) is indicated: : 1 in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies (14.1)], 2 in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies (14.2)], 3 for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies (14.3)], 4 for the treatment of patients with CLL refractory to fludarabine and alemtuzumab [see Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa. The antibody was generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line (NS0) using standard mammalian cell cultivation and purification technologies. ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate for intravenous administration. ARZERRA is supplied at a concentration of 20 mg/mL in single-use vials. Each single-use vial contains either 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution. Inactive ingredients include: 10 mg/mL arginine, diluted hydrochloric acid, 0.019 mg/mL edetate disodium, 0.2 mg/mL polysorbate 80, 6.8 mg/mL sodium acetate, 2.98 mg/mL sodium chloride, and Water for Injection, USP. The pH is 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0909-61</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0909-61)  *  28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50)  *  21 TABLET in 1 BLISTER PACK (0078-0888-21) </PackageDescription>
    <NDC11Code>00078-0909-61</NDC11Code>
    <ProductNDC>0078-0909</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kisqali Femara Co-pack</ProprietaryName>
    <NonProprietaryName>Letrozole And Ribociclib</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20170504</StartMarketingDate>
    <EndMarketingDate>20260831</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209935</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170504</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated: 1 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 as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer therapy. (1).</IndicationAndUsage>
    <Description>KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film-coated tablets co-packaged with letrozole 2.5 mg tablets. Ribociclib. KISQALI (ribociclib) is a kinase inhibitor. Ribociclib succinate is a light yellow to yellowish brown crystalline powder. 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). 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 hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients. Letrozole. FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is. FEMARA is available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0916-61</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0916-61)  *  28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50)  *  14 TABLET in 1 BLISTER PACK (0078-0895-14) </PackageDescription>
    <NDC11Code>00078-0916-61</NDC11Code>
    <ProductNDC>0078-0916</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kisqali Femara Co-pack</ProprietaryName>
    <NonProprietaryName>Letrozole And Ribociclib</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20170504</StartMarketingDate>
    <EndMarketingDate>20260831</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209935</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170504</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated: 1 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 as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer therapy. (1).</IndicationAndUsage>
    <Description>KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film-coated tablets co-packaged with letrozole 2.5 mg tablets. Ribociclib. KISQALI (ribociclib) is a kinase inhibitor. Ribociclib succinate is a light yellow to yellowish brown crystalline powder. 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). 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 hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients. Letrozole. FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is. FEMARA is available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0923-61</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0078-0923-61)  *  28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50)  *  21 TABLET in 1 BLISTER PACK (0078-0902-21) </PackageDescription>
    <NDC11Code>00078-0923-61</NDC11Code>
    <ProductNDC>0078-0923</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kisqali Femara Co-pack</ProprietaryName>
    <NonProprietaryName>Letrozole And Ribociclib</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20170504</StartMarketingDate>
    <EndMarketingDate>20260831</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209935</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170504</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated: 1 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 as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer therapy. (1).</IndicationAndUsage>
    <Description>KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film-coated tablets co-packaged with letrozole 2.5 mg tablets. Ribociclib. KISQALI (ribociclib) is a kinase inhibitor. Ribociclib succinate is a light yellow to yellowish brown crystalline powder. 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). 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 hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients. Letrozole. FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula C17H11N5, and a melting range of 184°C to 185°C. The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is. FEMARA is available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0979-50</NDCCode>
    <PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (0078-0979-50) </PackageDescription>
    <NDC11Code>00078-0979-50</NDC11Code>
    <ProductNDC>0078-0979</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mayzent</ProprietaryName>
    <NonProprietaryName>Siponimod</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190326</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209884</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SIPONIMOD</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190326</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MAYZENT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>MAYZENT tablets contains siponimod, an S1P receptor modulator, as 2:1 co-crystal of siponimod and fumaric acid and has the following chemical name. 1-[[4-[(1E)-1-[[[4-Cyclohexyl-3-(trifluoromethyl)phenyl]methoxy]imino]ethyl]-2-ethylphenyl]methyl]-3-azetidinecarboxylic acid (2E)-2-butenedioate (2:1). Its molecular formula is C4H4O42C29H35F3N2O3, and its molecular weight is 1149.29 g/mol. Its structure is shown below. It is a white to almost white powder. MAYZENT is provided as 0.25 mg, 1 mg, and 2 mg film-coated tablets for oral use. Each tablet contains 0.25 mg, 1 mg, or 2 mg siponimod, equivalent to 0.28 mg, 1.11 mg, or 2.22 mg as 2:1 co-crystal of siponimod and fumaric acid, respectively. MAYZENT tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, glyceryl dibehenate, lactose monohydrate, microcrystalline cellulose, with a film coating containing iron oxides (black and red iron oxides for the 0.25 mg and 1 mg strengths and red and yellow iron oxides for the 2 mg strength), lecithin (soy), polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-9659-50</NDCCode>
    <PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (0078-9659-50) </PackageDescription>
    <NDC11Code>00078-9659-50</NDC11Code>
    <ProductNDC>0078-9659</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Entresto</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150707</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207620</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180823</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)  .</IndicationAndUsage>
    <Description>ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)—water (1/15). Its empirical formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is. ENTRESTO is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are hypromellose, iron oxide red (E172), polyethylene glycol 4000, talc, and titanium dioxide (E171). The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black (E172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E172). ENTRESTO SPRINKLE is available as film-coated oral pellets within capsules for oral administration, containing 6 mg of sacubitril and 6 mg of valsartan; and 15 mg of sacubitril and 16 mg of valsartan. The oral pellet inactive ingredients are colloidal silicon dioxide, hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc. The film-coat inactive ingredients are basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, and talc. The capsule shell inactive ingredients are hypromellose and titanium dioxide (E171). The capsule shell for the 15 mg of sacubitril and 16 mg of valsartan oral pellets also contains iron oxide yellow (E172). The printing ink contains shellac, propylene glycol, iron oxide red (E172), ammonia solution (concentrated), and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>14501-0078-2</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (14501-0078-2) </PackageDescription>
    <NDC11Code>14501-0078-02</NDC11Code>
    <ProductNDC>14501-0078</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Roflumilast</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120322</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>MSN Laboratories Private Limited</LabelerName>
    <SubstanceName>ROFLUMILAST</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-23</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>22-MAR-12</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>37000-078-50</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE, PLASTIC (37000-078-50)</PackageDescription>
    <NDC11Code>37000-0078-50</NDC11Code>
    <ProductNDC>37000-078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Head And Shoulders</ProprietaryName>
    <ProprietaryNameSuffix>Green Apple 2in1</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>LOTION/SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>Procter &amp; Gamble Manufacturing Co.</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-11-18</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>37012-078-50</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE, PLASTIC (37012-078-50)</PackageDescription>
    <NDC11Code>37012-0078-50</NDC11Code>
    <ProductNDC>37012-078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Shopko Chest Congestion Relief Dmtdm</ProprietaryName>
    <ProprietaryNameSuffix>Tdm</ProprietaryNameSuffix>
    <NonProprietaryName>Dextromethorphan Hydrobromide / Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Shopko</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>20; 400</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus■ Helps make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>48087-0078-0</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (48087-0078-0) </PackageDescription>
    <NDC11Code>48087-0078-00</NDC11Code>
    <ProductNDC>48087-0078</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20100412</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.</LabelerName>
    <SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2021-12-18</LastUpdate>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-APR-10</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>49288-0078-5</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0078-5)</PackageDescription>
    <NDC11Code>49288-0078-05</NDC11Code>
    <ProductNDC>49288-0078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Red (river) Birch</ProprietaryName>
    <NonProprietaryName>Red (river) Birch</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>BETULA NIGRA POLLEN</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>57237-078-50</NDCCode>
    <PackageDescription>500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-50) </PackageDescription>
    <NDC11Code>57237-0078-50</NDC11Code>
    <ProductNDC>57237-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron</ProprietaryName>
    <NonProprietaryName>Ondansetron</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090469</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>ONDANSETRON</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240930</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy, 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
    <Description>The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula: The molecular formula is C18H19N3O representing a molecular weight of 293.4 g/mol. Ondansetron is a white to off-white powder. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing. Meets USP Disintegration Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>62350-0078-6</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (62350-0078-6) </PackageDescription>
    <NDC11Code>62350-0078-06</NDC11Code>
    <ProductNDC>62350-0078</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Docusate Sodium/sodium Benzoate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170519</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Wanbury Limited</LabelerName>
    <SubstanceName>DOCUSATE SODIUM/SODIUM BENZOATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-06</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19-MAY-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65862-078-50</NDCCode>
    <PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (65862-078-50) </PackageDescription>
    <NDC11Code>65862-0078-50</NDC11Code>
    <ProductNDC>65862-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070426</StartMarketingDate>
    <EndMarketingDate>20270131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077859</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20070426</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
    <Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3­-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>65977-0078-1</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (65977-0078-1) </PackageDescription>
    <NDC11Code>65977-0078-01</NDC11Code>
    <ProductNDC>65977-0078</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20071019</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Hetero Drugs Limited</LabelerName>
    <SubstanceName>SEVELAMER CARBONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19-OCT-07</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>66174-0078-0</NDCCode>
    <PackageDescription>50 kg in 1 DRUM (66174-0078-0)</PackageDescription>
    <NDC11Code>66174-0078-00</NDC11Code>
    <ProductNDC>66174-0078</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150223</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Srini Pharmaceuticals Limited</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>66343-078-50</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (66343-078-50) </PackageDescription>
    <NDC11Code>66343-0078-50</NDC11Code>
    <ProductNDC>66343-078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Geovita</ProprietaryName>
    <NonProprietaryName>Cerebrum, Ferrum Met, Silicea, Cuprum Met, Foricum Acidum</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190603</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>RUBIMED AG</LabelerName>
    <SubstanceName>SUS SCROFA CEREBRUM; IRON; SILICON DIOXIDE; COPPER; FORMIC ACID</SubstanceName>
    <StrengthNumber>21; 6; 12; 21; 21</StrengthNumber>
    <StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68225-078-50</NDCCode>
    <PackageDescription>198 BOX in 1 CONTAINER (68225-078-50)  &gt; 10 VIAL in 1 BOX &gt; 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>68225-0078-50</NDC11Code>
    <ProductNDC>68225-078</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Iopamidol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>19851231</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Italia S.p.A.</LabelerName>
    <SubstanceName>IOPAMIDOL</SubstanceName>
    <StrengthNumber>755</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2018-02-02</LastUpdate>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>71930-078-50</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (71930-078-50) </PackageDescription>
    <NDC11Code>71930-0078-50</NDC11Code>
    <ProductNDC>71930-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217160</ApplicationNumber>
    <LabelerName>Eywa Pharma Inc</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocortisone Tablets are indicated in the following conditions.</IndicationAndUsage>
    <Description>Hydrocortisone Tablets, USPcontain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USPare available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone, USP. Inactive ingredients: calcium stearate, corn starch, lactose monohydrate, sorbic acid, sucrose. Meets USP Dissolution Test 2. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.</Description>
  </NDC>
  <NDC>
    <NDCCode>75670-003-02</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (75670-003-02)  &gt; 50 POUCH in 1 BAG &gt; .0078 g in 1 POUCH</PackageDescription>
    <NDC11Code>75670-0003-02</NDC11Code>
    <ProductNDC>75670-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sanitizing Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride,didecyldimonium Chloride</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200609</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>SHANGHAI SANJUN GENERAL MERCHANDISE CO., LTD.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE; DIDECYLDIMONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1; .15</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200609</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>●For hand sanitizing to decrease bacteria on the skin. ●Apply topically to the skin to help prevent cross contamination. ●Recommended for repeated use. Dries in seconds.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83324-078-50</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (83324-078-50)  / 50 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>83324-0078-50</NDC11Code>
    <ProductNDC>83324-078</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Relief</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240403</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>CHAIN DRUG MARKETING ASSOCIATION, INC.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to: the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>87063-078-50</NDCCode>
    <PackageDescription>50 g in 1 JAR (87063-078-50) </PackageDescription>
    <NDC11Code>87063-0078-50</NDC11Code>
    <ProductNDC>87063-078</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Silver Sulfadiazine</ProprietaryName>
    <NonProprietaryName>Silver Sulfadiazine</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>19851223</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018810</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>SILVER SULFADIAZINE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.</IndicationAndUsage>
    <Description>Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application.  Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula:.      Silver sulfadiazine cream contains 1% w/w silver sulfadiazine.  The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative.</Description>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>0078-9777-50</NDCCode><ProprietaryName>Entresto</ProprietaryName><NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>0143-9777-50</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>0069-0078-01</NDCCode><ProprietaryName>Paclitaxel</ProprietaryName><NonProprietaryName>Paclitaxel</NonProprietaryName></NDC><NDC><NDCCode>0078-0110-22</NDCCode><ProprietaryName>Sandimmune</ProprietaryName><NonProprietaryName>Cyclosporine</NonProprietaryName></NDC><NDC><NDCCode>0078-0274-22</NDCCode><ProprietaryName>Neoral</ProprietaryName><NonProprietaryName>Cyclosporine</NonProprietaryName></NDC><NDC><NDCCode>0078-0368-64</NDCCode><ProprietaryName>Famvir</ProprietaryName><NonProprietaryName>Famciclovir</NonProprietaryName></NDC><NDC><NDCCode>0078-0683-06</NDCCode><ProprietaryName>Arranon</ProprietaryName><NonProprietaryName>Nelarabine</NonProprietaryName></NDC><NDC><NDCCode>0078-0683-61</NDCCode><ProprietaryName>Arranon</ProprietaryName><NonProprietaryName>Nelarabine</NonProprietaryName></NDC><NDC><NDCCode>0078-0690-61</NDCCode><ProprietaryName>Arzerra</ProprietaryName><NonProprietaryName>Ofatumumab</NonProprietaryName></NDC><NDC><NDCCode>0078-0909-61</NDCCode><ProprietaryName>Kisqali Femara Co-pack</ProprietaryName><NonProprietaryName>Letrozole And Ribociclib</NonProprietaryName></NDC><NDC><NDCCode>0078-0916-61</NDCCode><ProprietaryName>Kisqali Femara Co-pack</ProprietaryName><NonProprietaryName>Letrozole And Ribociclib</NonProprietaryName></NDC><NDC><NDCCode>0078-0923-61</NDCCode><ProprietaryName>Kisqali Femara Co-pack</ProprietaryName><NonProprietaryName>Letrozole And Ribociclib</NonProprietaryName></NDC><NDC><NDCCode>0078-0979-50</NDCCode><ProprietaryName>Mayzent</ProprietaryName><NonProprietaryName>Siponimod</NonProprietaryName></NDC><NDC><NDCCode>0078-9659-50</NDCCode><ProprietaryName>Entresto</ProprietaryName><NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName></NDC><NDC><NDCCode>14501-0078-2</NDCCode><NonProprietaryName>Roflumilast</NonProprietaryName></NDC><NDC><NDCCode>37000-078-50</NDCCode><ProprietaryName>Head And Shoulders</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>37012-078-50</NDCCode><ProprietaryName>Shopko Chest Congestion Relief Dmtdm</ProprietaryName><NonProprietaryName>Dextromethorphan Hydrobromide / Guaifenesin</NonProprietaryName></NDC><NDC><NDCCode>48087-0078-0</NDCCode><NonProprietaryName>Sitagliptin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>49288-0078-5</NDCCode><ProprietaryName>Red (river) Birch</ProprietaryName><NonProprietaryName>Red (river) Birch</NonProprietaryName></NDC><NDC><NDCCode>57237-078-50</NDCCode><ProprietaryName>Ondansetron</ProprietaryName><NonProprietaryName>Ondansetron</NonProprietaryName></NDC><NDC><NDCCode>62350-0078-6</NDCCode><NonProprietaryName>Docusate Sodium/sodium Benzoate</NonProprietaryName></NDC><NDC><NDCCode>65862-078-50</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>65977-0078-1</NDCCode><NonProprietaryName>Sevelamer Carbonate</NonProprietaryName></NDC><NDC><NDCCode>66174-0078-0</NDCCode><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>66343-078-50</NDCCode><ProprietaryName>Geovita</ProprietaryName><NonProprietaryName>Cerebrum, Ferrum Met, Silicea, Cuprum Met, Foricum Acidum</NonProprietaryName></NDC><NDC><NDCCode>68225-078-50</NDCCode><NonProprietaryName>Iopamidol</NonProprietaryName></NDC><NDC><NDCCode>71930-078-50</NDCCode><ProprietaryName>Hydrocortisone</ProprietaryName><NonProprietaryName>Hydrocortisone</NonProprietaryName></NDC><NDC><NDCCode>75670-003-02</NDCCode><ProprietaryName>Sanitizing Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride,didecyldimonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>83324-078-50</NDCCode><ProprietaryName>Pain Relief</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>87063-078-50</NDCCode><ProprietaryName>Silver Sulfadiazine</ProprietaryName><NonProprietaryName>Silver Sulfadiazine</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

            
{
  "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.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "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."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
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  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
{
  "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",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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