RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "55579-892-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55579-892-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (55579-892-01) ",
      "NDC11Code": "55579-0892-10",
      "ProductNDC": "55579-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sugammadex",
      "NonProprietaryName": "Sugammadex Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260728",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215260",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "SUGAMMADEX SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "gamma-Cyclodextrins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260728",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION ®(sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-Octakis-S-(2-carboxyethyl)- 6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G-Heptakis-S-(2- carboxyethyl)-6 A,6 B,6 C,6 D,6 E,6 F,6 G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:."
    },
    {
      "NDCCode": "55579-113-10",
      "PackageDescription": "1.1 mL in 1 AMPULE (55579-113-10)",
      "NDC11Code": "55579-0113-10",
      "ProductNDC": "55579-113",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cynanchum Vincetoxicum Root And Sulfur",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20130417",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm",
      "SubstanceName": "CYNANCHUM VINCETOXICUM ROOT; SULFUR",
      "StrengthNumber": "6; 4",
      "StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "55579-117-10",
      "PackageDescription": "2 mL in 1 AMPULE (55579-117-10)",
      "NDC11Code": "55579-0117-10",
      "ProductNDC": "55579-117",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": ".alpha.-lipoic Acid, Arnica Montana Root, Sus Scrofa Cartilage, Coenzyme A, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Nadide, Sodium Diethyl Oxalacetate, Sus Scrofa Placenta, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur And Comfrey Root",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20130429",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm",
      "SubstanceName": ".ALPHA.-LIPOIC ACID; ARNICA MONTANA ROOT; SUS SCROFA CARTILAGE; COENZYME A; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; SUS SCROFA PLACENTA; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT",
      "StrengthNumber": "8; 4; 6; 8; 3; 6; 6; 8; 8; 6; 2; 4; 6; 6",
      "StrengthUnit": "[hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "55579-162-10",
      "PackageDescription": "2.2 mL in 1 AMPULE (55579-162-10)",
      "NDC11Code": "55579-0162-10",
      "ProductNDC": "55579-162",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Arnica Montana Root And Atropa Belladonna And Calendula Officinalis Flowering Top And Matricaria Recutita And Achillea Millefolium And Calcium Sulfide And Comfrey Root And Aconitum Napellus And Bellis Perennis And Mercurius Solubilis And Hypericum Perforatum And Echinacea, Unspecified And Echinacea Purpurea And Hamamelis Virginiana Leaf",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20130117",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm",
      "SubstanceName": "ARNICA MONTANA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ACHILLEA MILLEFOLIUM; CALCIUM SULFIDE; COMFREY ROOT; ACONITUM NAPELLUS; BELLIS PERENNIS; MERCURIUS SOLUBILIS; HYPERICUM PERFORATUM; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA LEAF",
      "StrengthNumber": "2; 2; 2; 3; 3; 6; 6; 2; 2; 6; 2; 2; 2; 1",
      "StrengthUnit": "[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "55579-327-10",
      "PackageDescription": "1.1 mL in 1 AMPULE (55579-327-10)",
      "NDC11Code": "55579-0327-10",
      "ProductNDC": "55579-327",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Causticum, Colchicum Autumnale Bulb, Citrullus Colocynthis Fruit Pulp, Iron, Pseudognaphalium Obtusifolium, Lithium Benzoate, Toxicodendron Pubescens Leaf And Filipendula Ulmaria Root",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20130417",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm",
      "SubstanceName": "CAUSTICUM; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; IRON; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LITHIUM BENZOATE; TOXICODENDRON PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT",
      "StrengthNumber": "10; 10; 10; 10; 6; 10; 10; 10",
      "StrengthUnit": "[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "55579-400-01",
      "PackageDescription": "10 VIAL in 1 CARTON (55579-400-01)  > 5 mL in 1 VIAL",
      "NDC11Code": "55579-0400-01",
      "ProductNDC": "55579-400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rocuronium Bromide",
      "NonProprietaryName": "Rocuronium Bromide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190715",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091115",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "ROCURONIUM BROMIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190715",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55579-400-02",
      "PackageDescription": "10 VIAL in 1 CARTON (55579-400-02)  > 10 mL in 1 VIAL",
      "NDC11Code": "55579-0400-02",
      "ProductNDC": "55579-400",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rocuronium Bromide",
      "NonProprietaryName": "Rocuronium Bromide",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190715",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091115",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "ROCURONIUM BROMIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190715",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55579-937-88",
      "PackageDescription": "159 TRAY in 1 CARTON (55579-937-88)  > 5 AMPULE in 1 TRAY > 10 mL in 1 AMPULE",
      "NDC11Code": "55579-0937-88",
      "ProductNDC": "55579-937",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Sodium Chloride",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20160809",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "SODIUM CHLORIDE",
      "StrengthNumber": "9",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-19",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "09-AUG-16"
    },
    {
      "NDCCode": "10893-892-10",
      "PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (10893-892-10)  > 1 LIQUID in 1 BOTTLE, GLASS",
      "NDC11Code": "10893-0892-10",
      "ProductNDC": "10893-892",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Naturasil",
      "ProprietaryNameSuffix": "Ringworm",
      "NonProprietaryName": "Sulfur",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111001",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Nature's Innovation, Inc.",
      "SubstanceName": "SULFUR",
      "StrengthNumber": "6",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "16714-892-11",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-11)  > 10 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "16714-0892-11",
      "ProductNDC": "16714-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Daptomycin",
      "NonProprietaryName": "Daptomycin",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190515",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208375",
      "LabelerName": "NorthStar RxLLC",
      "SubstanceName": "DAPTOMYCIN",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Lipopeptide Antibacterial [EPC],Lipopeptides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190515",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "17478-892-10",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17478-892-10)  > 5 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "17478-0892-10",
      "ProductNDC": "17478-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac",
      "NonProprietaryName": "Diclofenac Sodium",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20080501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077845",
      "LabelerName": "Akorn",
      "SubstanceName": "DICLOFENAC SODIUM",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20080501",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "31722-892-32",
      "PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-892-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-892-31) ",
      "NDC11Code": "31722-0892-32",
      "ProductNDC": "31722-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251006",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209242",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "20; 5; 12.5",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251006",
      "SamplePackage": "N",
      "IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.",
      "Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 3,5-pyridine  dicarboxylic  acid,  2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl    5-methyl    ester,     (±)-monobenzene sulfonate. Its empirical formula is C 26H 31CIN 2O 8S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 6-chloro-3, 4-dihydro-2 H-1, 2, 4-benzothiadiazine-7-sulphonamide 1,1- dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white or almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odourless, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Amlodipine besylate USP is slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol. Hydrochlorothiazide USP is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethyl formamide, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains iron oxide black, iron oxide red, iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide. The botanical source for pregelatinized starch is corn starch."
    },
    {
      "NDCCode": "37000-892-10",
      "PackageDescription": "2 CARTON in 1 CELLO PACK (37000-892-10)  / 1 TUBE in 1 CARTON / 144 g in 1 TUBE",
      "NDC11Code": "37000-0892-10",
      "ProductNDC": "37000-892",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crest Pro-health Advanced",
      "NonProprietaryName": "Stannous Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20161229",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "STANNOUS FLUORIDE",
      "StrengthNumber": "1.6",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2025-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161229",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact."
    },
    {
      "NDCCode": "49348-892-10",
      "PackageDescription": "1 BOTTLE in 1 CARTON (49348-892-10)  > 100 TABLET, COATED in 1 BOTTLE",
      "NDC11Code": "49348-0892-10",
      "ProductNDC": "49348-892",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunmark Pain Relief",
      "ProprietaryNameSuffix": "Extra Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090804",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "McKesson",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "54458-892-10",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (54458-892-10) ",
      "NDC11Code": "54458-0892-10",
      "ProductNDC": "54458-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Escitalopram",
      "NonProprietaryName": "Escitalopram",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130919",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076765",
      "LabelerName": "International Laboratories, LLC",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20130919",
      "EndMarketingDatePackage": "20191231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2).",
      "Description": "Escitalopram tablets USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP, is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. C20H21FN2O  C2H2O4  M.W. 414.43. Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP are film-coated, round tablets containing escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide."
    },
    {
      "NDCCode": "62157-892-01",
      "PackageDescription": "10 g in 1 JAR (62157-892-01)",
      "NDC11Code": "62157-0892-01",
      "ProductNDC": "62157-892",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Diethylstilbestrol",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20190718",
      "MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
      "LabelerName": "AX Pharmaceutical Corp",
      "SubstanceName": "DIETHYLSTILBESTROL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "62207-892-51",
      "PackageDescription": "1 BOTTLE in 1 CARTON (62207-892-51)  / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "62207-0892-51",
      "ProductNDC": "62207-892",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260416",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211544",
      "LabelerName": "Granules India Limited",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "650",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-06-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260416",
      "SamplePackage": "N",
      "IndicationAndUsage": "For Arthritis Pain label  temporarily relieves minor aches and pains due to:      minor pain of arthritis      muscular aches      backache      premenstrual and menstrual cramps      the common cold      headache      toothache  temporarily reduces fever. For Muscle Aches & Pain label  temporarily relieves minor aches and pains due to:      muscular aches      backache      minor pain of arthritis      toothache      premenstrual and menstrual cramps      headache      the common cold  temporarily reduces fever."
    },
    {
      "NDCCode": "65862-892-03",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (65862-892-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-892-10) ",
      "NDC11Code": "65862-0892-03",
      "ProductNDC": "65862-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Voriconazole",
      "NonProprietaryName": "Voriconazole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160122",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206837",
      "LabelerName": "Aurobindo Pharma Limited",
      "SubstanceName": "VORICONAZOLE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160122",
      "SamplePackage": "N",
      "IndicationAndUsage": "Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2) , 3 Esophageal candidiasis (1.3) , 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4) .",
      "Description": "Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4- pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole USP drug substance is a white to almost white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole USP. The inactive ingredients include colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (maize), titanium dioxide and triacetin."
    },
    {
      "NDCCode": "70069-892-10",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70069-892-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (70069-892-01) ",
      "NDC11Code": "70069-0892-10",
      "ProductNDC": "70069-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sugammadex",
      "NonProprietaryName": "Sugammadex",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260728",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215260",
      "LabelerName": "Somerset Therapeutics, LLC",
      "SubstanceName": "SUGAMMADEX SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "gamma-Cyclodextrins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260728",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2- carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is."
    },
    {
      "NDCCode": "70954-892-10",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (70954-892-10) ",
      "NDC11Code": "70954-0892-10",
      "ProductNDC": "70954-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rifampin",
      "NonProprietaryName": "Rifampin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260720",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219918",
      "LabelerName": "ANI Pharmaceuticals, Inc.",
      "SubstanceName": "RIFAMPIN",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260720",
      "SamplePackage": "N",
      "IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. Tuberculosis. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive. Meningococcal Carriers. Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (See WARNINGS.). Rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Rifampin Capsules, USP for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: magnesium stearate, docusate sodium, sodium benzoate, pregelatinized starch, talc, microcrystalline cellulose and colloidal silicon dioxide. The hard gelatin capsules contain gelatin, purified water, sodium lauryl sulfate, titanium dioxide, FD&C Red No. 40, D&C Red No. 28 and FD&C Blue No. 1. The imprinting ink contains shellac, black iron oxide, potassium hydroxide and propylene glycol. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "76420-892-01",
      "PackageDescription": "1 KIT in 1 CARTON (76420-892-01)  *  10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05)  / 5 mL in 1 VIAL, SINGLE-DOSE *  .9 mL in 1 PACKET (67777-419-02)  *  5 mL in 1 POUCH *  1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01)  / 5 mL in 1 VIAL, MULTI-DOSE *  10 BOTTLE, PLASTIC in 1 BOX (65219-383-05)  / 50 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "76420-0892-01",
      "ProductNDC": "76420-892",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bl-c Kit",
      "NonProprietaryName": "Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Iodixanol, Povidine Iodine",
      "DosageFormName": "KIT",
      "RouteName": "INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVASCULAR; PERINEURAL; TOPICAL",
      "StartMarketingDate": "20241231",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Asclemed USA, Inc.",
      "Status": "Active",
      "LastUpdate": "2025-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55579-397-88",
      "PackageDescription": "400 AMPULE in 1 CARTON (55579-397-88)  > 2 mL in 1 AMPULE",
      "NDC11Code": "55579-0397-88",
      "ProductNDC": "55579-397",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20190402",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-19",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "02-APR-19"
    },
    {
      "NDCCode": "55579-401-25",
      "PackageDescription": "25 AMPULE in 1 CARTON (55579-401-25)  > 1 mL in 1 AMPULE",
      "NDC11Code": "55579-0401-25",
      "ProductNDC": "55579-401",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Promethazine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20080424",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-19",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "24-APR-08"
    },
    {
      "NDCCode": "55579-402-25",
      "PackageDescription": "25 AMPULE in 1 CARTON (55579-402-25)  > 1 mL in 1 AMPULE",
      "NDC11Code": "55579-0402-25",
      "ProductNDC": "55579-402",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Promethazine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "StartMarketingDate": "20080424",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-19",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "24-APR-08"
    },
    {
      "NDCCode": "55579-405-24",
      "PackageDescription": "24 VIAL, GLASS in 1 CARTON (55579-405-24)  > 100 mL in 1 VIAL, GLASS",
      "NDC11Code": "55579-0405-24",
      "ProductNDC": "55579-405",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20201207",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202605",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2022-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Acetaminophen injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older , 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older , 3 the reduction of fever in adult and pediatric patients. .",
      "Description": "Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is. Acetaminophen injection is a sterile, clear, colorless to slightly yellowish, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.5 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1000 mg acetaminophen, USP, 3850 mg D-mannitol, USP, 25 mg cysteine hydrochloride, monohydrate, USP, and 13 mg disodium phosphate dihydrate, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide."
    },
    {
      "NDCCode": "55579-939-88",
      "PackageDescription": "262 TRAY in 1 CARTON (55579-939-88)  > 5 AMPULE in 1 TRAY > 5 mL in 1 AMPULE",
      "NDC11Code": "55579-0939-88",
      "ProductNDC": "55579-939",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "LIQUID",
      "StartMarketingDate": "20180803",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Solupharm Pharmazeutische Erzeugnisse GmbH",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2022-10-19",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "03-AUG-18"
    },
    {
      "NDCCode": "11071-892-01",
      "PackageDescription": "31 g in 1 DRUM (11071-892-01) ",
      "NDC11Code": "11071-0892-01",
      "ProductNDC": "11071-892",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Eribulin Mesylate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20101115",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Eisai Co., Ltd.",
      "SubstanceName": "ERIBULIN MESYLATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2023-06-28",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "15-NOV-10"
    },
    {
      "NDCCode": "11673-412-01",
      "PackageDescription": "2 g in 1 TUBE (11673-412-01) ",
      "NDC11Code": "11673-0412-01",
      "ProductNDC": "11673-412",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Maximum Strength Cold Sore Treatment",
      "NonProprietaryName": "Camphor, Menthol, Phenol, White Petrolatum",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190627",
      "EndMarketingDate": "20260223",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Target Corporation",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL",
      "StrengthNumber": "30; 10; 892; 15",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190627",
      "EndMarketingDatePackage": "20260223",
      "SamplePackage": "N",
      "IndicationAndUsage": "For treatment of cold sores/fever blisters on the face or lips. Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters. Temporarily protects minor cuts, scrapes, burns, and sores. Helps prevent and temporarily protects chapped or cracked skin and lips."
    },
    {
      "NDCCode": "14593-892-01",
      "PackageDescription": "5 kg in 1 JAR (14593-892-01) ",
      "NDC11Code": "14593-0892-01",
      "ProductNDC": "14593-892",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Gemcitabine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200505",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Emcure Pharmaceuticals Limited",
      "SubstanceName": "GEMCITABINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-16",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "05-MAY-20"
    },
    {
      "NDCCode": "14593-892-02",
      "PackageDescription": "15 kg in 1 DRUM (14593-892-02) ",
      "NDC11Code": "14593-0892-02",
      "ProductNDC": "14593-892",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Gemcitabine Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200505",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Emcure Pharmaceuticals Limited",
      "SubstanceName": "GEMCITABINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "kg/10kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-12-16",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "05-MAY-20"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"55579-892-10","ProprietaryName":"Sugammadex","NonProprietaryName":"Sugammadex Sodium"},{"NDCCode":"55579-113-10","NonProprietaryName":"Cynanchum Vincetoxicum Root And Sulfur"},{"NDCCode":"55579-117-10","NonProprietaryName":".alpha.-lipoic Acid, Arnica Montana Root, Sus Scrofa Cartilage, Coenzyme A, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Nadide, Sodium Diethyl Oxalacetate, Sus Scrofa Placenta, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur And Comfrey Root"},{"NDCCode":"55579-162-10","NonProprietaryName":"Arnica Montana Root And Atropa Belladonna And Calendula Officinalis Flowering Top And Matricaria Recutita And Achillea Millefolium And Calcium Sulfide And Comfrey Root And Aconitum Napellus And Bellis Perennis And Mercurius Solubilis And Hypericum Perforatum And Echinacea, Unspecified And Echinacea Purpurea And Hamamelis Virginiana Leaf"},{"NDCCode":"55579-327-10","NonProprietaryName":"Causticum, Colchicum Autumnale Bulb, Citrullus Colocynthis Fruit Pulp, Iron, Pseudognaphalium Obtusifolium, Lithium Benzoate, Toxicodendron Pubescens Leaf And Filipendula Ulmaria Root"},{"NDCCode":"55579-400-01","ProprietaryName":"Rocuronium Bromide","NonProprietaryName":"Rocuronium Bromide"},{"NDCCode":"55579-400-02","ProprietaryName":"Rocuronium Bromide","NonProprietaryName":"Rocuronium Bromide"},{"NDCCode":"55579-937-88","NonProprietaryName":"Sodium Chloride"},{"NDCCode":"10893-892-10","ProprietaryName":"Naturasil","NonProprietaryName":"Sulfur"},{"NDCCode":"16714-892-11","ProprietaryName":"Daptomycin","NonProprietaryName":"Daptomycin"},{"NDCCode":"17478-892-10","ProprietaryName":"Diclofenac","NonProprietaryName":"Diclofenac Sodium"},{"NDCCode":"31722-892-32","ProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide","NonProprietaryName":"Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide"},{"NDCCode":"37000-892-10","ProprietaryName":"Crest Pro-health Advanced","NonProprietaryName":"Stannous Fluoride"},{"NDCCode":"49348-892-10","ProprietaryName":"Sunmark Pain Relief","NonProprietaryName":"Acetaminophen"},{"NDCCode":"54458-892-10","ProprietaryName":"Escitalopram","NonProprietaryName":"Escitalopram"},{"NDCCode":"62157-892-01","NonProprietaryName":"Diethylstilbestrol"},{"NDCCode":"62207-892-51","ProprietaryName":"Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"65862-892-03","ProprietaryName":"Voriconazole","NonProprietaryName":"Voriconazole"},{"NDCCode":"70069-892-10","ProprietaryName":"Sugammadex","NonProprietaryName":"Sugammadex"},{"NDCCode":"70954-892-10","ProprietaryName":"Rifampin","NonProprietaryName":"Rifampin"},{"NDCCode":"76420-892-01","ProprietaryName":"Bl-c Kit","NonProprietaryName":"Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Iodixanol, Povidine Iodine"},{"NDCCode":"55579-397-88","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"55579-401-25","NonProprietaryName":"Promethazine Hydrochloride"},{"NDCCode":"55579-402-25","NonProprietaryName":"Promethazine Hydrochloride"},{"NDCCode":"55579-405-24","ProprietaryName":"Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"55579-939-88","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"11071-892-01","NonProprietaryName":"Eribulin Mesylate"},{"NDCCode":"11673-412-01","ProprietaryName":"Maximum Strength Cold Sore Treatment","NonProprietaryName":"Camphor, Menthol, Phenol, White Petrolatum"},{"NDCCode":"14593-892-01","NonProprietaryName":"Gemcitabine Hydrochloride"},{"NDCCode":"14593-892-02","NonProprietaryName":"Gemcitabine Hydrochloride"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>55579-892-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55579-892-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (55579-892-01) </PackageDescription>
    <NDC11Code>55579-0892-10</NDC11Code>
    <ProductNDC>55579-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215260</ApplicationNumber>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC's BRIDION ®(sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-Octakis-S-(2-carboxyethyl)- 6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G-Heptakis-S-(2- carboxyethyl)-6 A,6 B,6 C,6 D,6 E,6 F,6 G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>55579-113-10</NDCCode>
    <PackageDescription>1.1 mL in 1 AMPULE (55579-113-10)</PackageDescription>
    <NDC11Code>55579-0113-10</NDC11Code>
    <ProductNDC>55579-113</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cynanchum Vincetoxicum Root And Sulfur</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20130417</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm</LabelerName>
    <SubstanceName>CYNANCHUM VINCETOXICUM ROOT; SULFUR</SubstanceName>
    <StrengthNumber>6; 4</StrengthNumber>
    <StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55579-117-10</NDCCode>
    <PackageDescription>2 mL in 1 AMPULE (55579-117-10)</PackageDescription>
    <NDC11Code>55579-0117-10</NDC11Code>
    <ProductNDC>55579-117</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>.alpha.-lipoic Acid, Arnica Montana Root, Sus Scrofa Cartilage, Coenzyme A, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Nadide, Sodium Diethyl Oxalacetate, Sus Scrofa Placenta, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur And Comfrey Root</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20130429</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm</LabelerName>
    <SubstanceName>.ALPHA.-LIPOIC ACID; ARNICA MONTANA ROOT; SUS SCROFA CARTILAGE; COENZYME A; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; SUS SCROFA PLACENTA; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT</SubstanceName>
    <StrengthNumber>8; 4; 6; 8; 3; 6; 6; 8; 8; 6; 2; 4; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55579-162-10</NDCCode>
    <PackageDescription>2.2 mL in 1 AMPULE (55579-162-10)</PackageDescription>
    <NDC11Code>55579-0162-10</NDC11Code>
    <ProductNDC>55579-162</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Arnica Montana Root And Atropa Belladonna And Calendula Officinalis Flowering Top And Matricaria Recutita And Achillea Millefolium And Calcium Sulfide And Comfrey Root And Aconitum Napellus And Bellis Perennis And Mercurius Solubilis And Hypericum Perforatum And Echinacea, Unspecified And Echinacea Purpurea And Hamamelis Virginiana Leaf</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20130117</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm</LabelerName>
    <SubstanceName>ARNICA MONTANA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ACHILLEA MILLEFOLIUM; CALCIUM SULFIDE; COMFREY ROOT; ACONITUM NAPELLUS; BELLIS PERENNIS; MERCURIUS SOLUBILIS; HYPERICUM PERFORATUM; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA LEAF</SubstanceName>
    <StrengthNumber>2; 2; 2; 3; 3; 6; 6; 2; 2; 6; 2; 2; 2; 1</StrengthNumber>
    <StrengthUnit>[hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55579-327-10</NDCCode>
    <PackageDescription>1.1 mL in 1 AMPULE (55579-327-10)</PackageDescription>
    <NDC11Code>55579-0327-10</NDC11Code>
    <ProductNDC>55579-327</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Causticum, Colchicum Autumnale Bulb, Citrullus Colocynthis Fruit Pulp, Iron, Pseudognaphalium Obtusifolium, Lithium Benzoate, Toxicodendron Pubescens Leaf And Filipendula Ulmaria Root</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20130417</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm</LabelerName>
    <SubstanceName>CAUSTICUM; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; IRON; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LITHIUM BENZOATE; TOXICODENDRON PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT</SubstanceName>
    <StrengthNumber>10; 10; 10; 10; 6; 10; 10; 10</StrengthNumber>
    <StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55579-400-01</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (55579-400-01)  &gt; 5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55579-0400-01</NDC11Code>
    <ProductNDC>55579-400</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rocuronium Bromide</ProprietaryName>
    <NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091115</ApplicationNumber>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-07-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55579-400-02</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (55579-400-02)  &gt; 10 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55579-0400-02</NDC11Code>
    <ProductNDC>55579-400</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rocuronium Bromide</ProprietaryName>
    <NonProprietaryName>Rocuronium Bromide</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091115</ApplicationNumber>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>ROCURONIUM BROMIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-07-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55579-937-88</NDCCode>
    <PackageDescription>159 TRAY in 1 CARTON (55579-937-88)  &gt; 5 AMPULE in 1 TRAY &gt; 10 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>55579-0937-88</NDC11Code>
    <ProductNDC>55579-937</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Sodium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20160809</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-19</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>09-AUG-16</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10893-892-10</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (10893-892-10)  &gt; 1 LIQUID in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>10893-0892-10</NDC11Code>
    <ProductNDC>10893-892</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naturasil</ProprietaryName>
    <ProprietaryNameSuffix>Ringworm</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfur</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nature's Innovation, Inc.</LabelerName>
    <SubstanceName>SULFUR</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>16714-892-11</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-11)  &gt; 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>16714-0892-11</NDC11Code>
    <ProductNDC>16714-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daptomycin</ProprietaryName>
    <NonProprietaryName>Daptomycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208375</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Lipopeptide Antibacterial [EPC],Lipopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>17478-892-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (17478-892-10)  &gt; 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>17478-0892-10</NDC11Code>
    <ProductNDC>17478-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20080501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077845</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>31722-892-32</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (31722-892-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-892-31) </PackageDescription>
    <NDC11Code>31722-0892-32</NDC11Code>
    <ProductNDC>31722-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209242</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>20; 5; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
    <Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 3,5-pyridine  dicarboxylic  acid,  2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl    5-methyl    ester,     (±)-monobenzene sulfonate. Its empirical formula is C 26H 31CIN 2O 8S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 6-chloro-3, 4-dihydro-2 H-1, 2, 4-benzothiadiazine-7-sulphonamide 1,1- dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white or almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odourless, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Amlodipine besylate USP is slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol. Hydrochlorothiazide USP is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethyl formamide, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains iron oxide black, iron oxide red, iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide. The botanical source for pregelatinized starch is corn starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-892-10</NDCCode>
    <PackageDescription>2 CARTON in 1 CELLO PACK (37000-892-10)  / 1 TUBE in 1 CARTON / 144 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0892-10</NDC11Code>
    <ProductNDC>37000-892</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Pro-health Advanced</ProprietaryName>
    <NonProprietaryName>Stannous Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20161229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>STANNOUS FLUORIDE</SubstanceName>
    <StrengthNumber>1.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49348-892-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49348-892-10)  &gt; 100 TABLET, COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0892-10</NDC11Code>
    <ProductNDC>49348-892</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark Pain Relief</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090804</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>McKesson</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>54458-892-10</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (54458-892-10) </PackageDescription>
    <NDC11Code>54458-0892-10</NDC11Code>
    <ProductNDC>54458-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram</ProprietaryName>
    <NonProprietaryName>Escitalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076765</ApplicationNumber>
    <LabelerName>International Laboratories, LLC</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130919</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2).</IndicationAndUsage>
    <Description>Escitalopram tablets USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP, is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. C20H21FN2O  C2H2O4  M.W. 414.43. Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP are film-coated, round tablets containing escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62157-892-01</NDCCode>
    <PackageDescription>10 g in 1 JAR (62157-892-01)</PackageDescription>
    <NDC11Code>62157-0892-01</NDC11Code>
    <ProductNDC>62157-892</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diethylstilbestrol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190718</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
    <LabelerName>AX Pharmaceutical Corp</LabelerName>
    <SubstanceName>DIETHYLSTILBESTROL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62207-892-51</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (62207-892-51)  / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>62207-0892-51</NDC11Code>
    <ProductNDC>62207-892</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211544</ApplicationNumber>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For Arthritis Pain label  temporarily relieves minor aches and pains due to:      minor pain of arthritis      muscular aches      backache      premenstrual and menstrual cramps      the common cold      headache      toothache  temporarily reduces fever. For Muscle Aches &amp; Pain label  temporarily relieves minor aches and pains due to:      muscular aches      backache      minor pain of arthritis      toothache      premenstrual and menstrual cramps      headache      the common cold  temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65862-892-03</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (65862-892-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-892-10) </PackageDescription>
    <NDC11Code>65862-0892-03</NDC11Code>
    <ProductNDC>65862-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206837</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2) , 3 Esophageal candidiasis (1.3) , 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4) .</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4- pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole USP drug substance is a white to almost white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole USP. The inactive ingredients include colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (maize), titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-892-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70069-892-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (70069-892-01) </PackageDescription>
    <NDC11Code>70069-0892-10</NDC11Code>
    <ProductNDC>70069-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215260</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2- carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-892-10</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (70954-892-10) </PackageDescription>
    <NDC11Code>70954-0892-10</NDC11Code>
    <ProductNDC>70954-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rifampin</ProprietaryName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260720</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219918</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. Tuberculosis. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive. Meningococcal Carriers. Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (See WARNINGS.). Rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Rifampin Capsules, USP for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: magnesium stearate, docusate sodium, sodium benzoate, pregelatinized starch, talc, microcrystalline cellulose and colloidal silicon dioxide. The hard gelatin capsules contain gelatin, purified water, sodium lauryl sulfate, titanium dioxide, FD&amp;C Red No. 40, D&amp;C Red No. 28 and FD&amp;C Blue No. 1. The imprinting ink contains shellac, black iron oxide, potassium hydroxide and propylene glycol. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-892-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (76420-892-01)  *  10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05)  / 5 mL in 1 VIAL, SINGLE-DOSE *  .9 mL in 1 PACKET (67777-419-02)  *  5 mL in 1 POUCH *  1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01)  / 5 mL in 1 VIAL, MULTI-DOSE *  10 BOTTLE, PLASTIC in 1 BOX (65219-383-05)  / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>76420-0892-01</NDC11Code>
    <ProductNDC>76420-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bl-c Kit</ProprietaryName>
    <NonProprietaryName>Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Iodixanol, Povidine Iodine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVASCULAR; PERINEURAL; TOPICAL</RouteName>
    <StartMarketingDate>20241231</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55579-397-88</NDCCode>
    <PackageDescription>400 AMPULE in 1 CARTON (55579-397-88)  &gt; 2 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>55579-0397-88</NDC11Code>
    <ProductNDC>55579-397</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20190402</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-19</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>02-APR-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>55579-401-25</NDCCode>
    <PackageDescription>25 AMPULE in 1 CARTON (55579-401-25)  &gt; 1 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>55579-0401-25</NDC11Code>
    <ProductNDC>55579-401</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20080424</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-19</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>24-APR-08</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>55579-402-25</NDCCode>
    <PackageDescription>25 AMPULE in 1 CARTON (55579-402-25)  &gt; 1 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>55579-0402-25</NDC11Code>
    <ProductNDC>55579-402</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <StartMarketingDate>20080424</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-19</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>24-APR-08</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>55579-405-24</NDCCode>
    <PackageDescription>24 VIAL, GLASS in 1 CARTON (55579-405-24)  &gt; 100 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>55579-0405-24</NDC11Code>
    <ProductNDC>55579-405</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20201207</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202605</ApplicationNumber>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acetaminophen injection is indicated for: 1 the management of mild to moderate pain in adult and pediatric patients 2 years and older , 2 the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older , 3 the reduction of fever in adult and pediatric patients. .</IndicationAndUsage>
    <Description>Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is. Acetaminophen injection is a sterile, clear, colorless to slightly yellowish, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.5 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1000 mg acetaminophen, USP, 3850 mg D-mannitol, USP, 25 mg cysteine hydrochloride, monohydrate, USP, and 13 mg disodium phosphate dihydrate, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55579-939-88</NDCCode>
    <PackageDescription>262 TRAY in 1 CARTON (55579-939-88)  &gt; 5 AMPULE in 1 TRAY &gt; 5 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>55579-0939-88</NDC11Code>
    <ProductNDC>55579-939</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20180803</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-10-19</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>03-AUG-18</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11071-892-01</NDCCode>
    <PackageDescription>31 g in 1 DRUM (11071-892-01) </PackageDescription>
    <NDC11Code>11071-0892-01</NDC11Code>
    <ProductNDC>11071-892</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Eribulin Mesylate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101115</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Eisai Co., Ltd.</LabelerName>
    <SubstanceName>ERIBULIN MESYLATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-06-28</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-NOV-10</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>11673-412-01</NDCCode>
    <PackageDescription>2 g in 1 TUBE (11673-412-01) </PackageDescription>
    <NDC11Code>11673-0412-01</NDC11Code>
    <ProductNDC>11673-412</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Maximum Strength Cold Sore Treatment</ProprietaryName>
    <NonProprietaryName>Camphor, Menthol, Phenol, White Petrolatum</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190627</StartMarketingDate>
    <EndMarketingDate>20260223</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PETROLATUM; PHENOL</SubstanceName>
    <StrengthNumber>30; 10; 892; 15</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190627</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260223</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For treatment of cold sores/fever blisters on the face or lips. Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters. Temporarily protects minor cuts, scrapes, burns, and sores. Helps prevent and temporarily protects chapped or cracked skin and lips.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>14593-892-01</NDCCode>
    <PackageDescription>5 kg in 1 JAR (14593-892-01) </PackageDescription>
    <NDC11Code>14593-0892-01</NDC11Code>
    <ProductNDC>14593-892</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200505</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
    <SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>05-MAY-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>14593-892-02</NDCCode>
    <PackageDescription>15 kg in 1 DRUM (14593-892-02) </PackageDescription>
    <NDC11Code>14593-0892-02</NDC11Code>
    <ProductNDC>14593-892</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200505</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
    <SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>kg/10kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>05-MAY-20</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>55579-892-10</NDCCode><ProprietaryName>Sugammadex</ProprietaryName><NonProprietaryName>Sugammadex Sodium</NonProprietaryName></NDC><NDC><NDCCode>55579-113-10</NDCCode><NonProprietaryName>Cynanchum Vincetoxicum Root And Sulfur</NonProprietaryName></NDC><NDC><NDCCode>55579-117-10</NDCCode><NonProprietaryName>.alpha.-lipoic Acid, Arnica Montana Root, Sus Scrofa Cartilage, Coenzyme A, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Nadide, Sodium Diethyl Oxalacetate, Sus Scrofa Placenta, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur And Comfrey Root</NonProprietaryName></NDC><NDC><NDCCode>55579-162-10</NDCCode><NonProprietaryName>Arnica Montana Root And Atropa Belladonna And Calendula Officinalis Flowering Top And Matricaria Recutita And Achillea Millefolium And Calcium Sulfide And Comfrey Root And Aconitum Napellus And Bellis Perennis And Mercurius Solubilis And Hypericum Perforatum And Echinacea, Unspecified And Echinacea Purpurea And Hamamelis Virginiana Leaf</NonProprietaryName></NDC><NDC><NDCCode>55579-327-10</NDCCode><NonProprietaryName>Causticum, Colchicum Autumnale Bulb, Citrullus Colocynthis Fruit Pulp, Iron, Pseudognaphalium Obtusifolium, Lithium Benzoate, Toxicodendron Pubescens Leaf And Filipendula Ulmaria Root</NonProprietaryName></NDC><NDC><NDCCode>55579-400-01</NDCCode><ProprietaryName>Rocuronium Bromide</ProprietaryName><NonProprietaryName>Rocuronium Bromide</NonProprietaryName></NDC><NDC><NDCCode>55579-400-02</NDCCode><ProprietaryName>Rocuronium Bromide</ProprietaryName><NonProprietaryName>Rocuronium Bromide</NonProprietaryName></NDC><NDC><NDCCode>55579-937-88</NDCCode><NonProprietaryName>Sodium Chloride</NonProprietaryName></NDC><NDC><NDCCode>10893-892-10</NDCCode><ProprietaryName>Naturasil</ProprietaryName><NonProprietaryName>Sulfur</NonProprietaryName></NDC><NDC><NDCCode>16714-892-11</NDCCode><ProprietaryName>Daptomycin</ProprietaryName><NonProprietaryName>Daptomycin</NonProprietaryName></NDC><NDC><NDCCode>17478-892-10</NDCCode><ProprietaryName>Diclofenac</ProprietaryName><NonProprietaryName>Diclofenac Sodium</NonProprietaryName></NDC><NDC><NDCCode>31722-892-32</NDCCode><ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>37000-892-10</NDCCode><ProprietaryName>Crest Pro-health Advanced</ProprietaryName><NonProprietaryName>Stannous Fluoride</NonProprietaryName></NDC><NDC><NDCCode>49348-892-10</NDCCode><ProprietaryName>Sunmark Pain Relief</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>54458-892-10</NDCCode><ProprietaryName>Escitalopram</ProprietaryName><NonProprietaryName>Escitalopram</NonProprietaryName></NDC><NDC><NDCCode>62157-892-01</NDCCode><NonProprietaryName>Diethylstilbestrol</NonProprietaryName></NDC><NDC><NDCCode>62207-892-51</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>65862-892-03</NDCCode><ProprietaryName>Voriconazole</ProprietaryName><NonProprietaryName>Voriconazole</NonProprietaryName></NDC><NDC><NDCCode>70069-892-10</NDCCode><ProprietaryName>Sugammadex</ProprietaryName><NonProprietaryName>Sugammadex</NonProprietaryName></NDC><NDC><NDCCode>70954-892-10</NDCCode><ProprietaryName>Rifampin</ProprietaryName><NonProprietaryName>Rifampin</NonProprietaryName></NDC><NDC><NDCCode>76420-892-01</NDCCode><ProprietaryName>Bl-c Kit</ProprietaryName><NonProprietaryName>Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Iodixanol, Povidine Iodine</NonProprietaryName></NDC><NDC><NDCCode>55579-397-88</NDCCode><NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55579-401-25</NDCCode><NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55579-402-25</NDCCode><NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55579-405-24</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>55579-939-88</NDCCode><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>11071-892-01</NDCCode><NonProprietaryName>Eribulin Mesylate</NonProprietaryName></NDC><NDC><NDCCode>11673-412-01</NDCCode><ProprietaryName>Maximum Strength Cold Sore Treatment</ProprietaryName><NonProprietaryName>Camphor, Menthol, Phenol, White Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>14593-892-01</NDCCode><NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>14593-892-02</NDCCode><NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "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",
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      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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