RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "0126-0025-14",
      "PackageDescription": "887 mL in 1 BOTTLE (0126-0025-14)",
      "NDC11Code": "00126-0025-14",
      "ProductNDC": "0126-0025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate Total",
      "ProprietaryNameSuffix": "Gentle Care Softmint",
      "NonProprietaryName": "Cetylpyridinium Chloride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
      "StrengthNumber": "10.5",
      "StrengthUnit": "mg/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-13",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0126-0025-08",
      "PackageDescription": "236 mL in 1 BOTTLE (0126-0025-08)",
      "NDC11Code": "00126-0025-08",
      "ProductNDC": "0126-0025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate Total",
      "ProprietaryNameSuffix": "Gentle Care Softmint",
      "NonProprietaryName": "Cetylpyridinium Chloride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
      "StrengthNumber": "10.5",
      "StrengthUnit": "mg/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-13",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0126-0025-16",
      "PackageDescription": "473 mL in 1 BOTTLE (0126-0025-16)",
      "NDC11Code": "00126-0025-16",
      "ProductNDC": "0126-0025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate Total",
      "ProprietaryNameSuffix": "Gentle Care Softmint",
      "NonProprietaryName": "Cetylpyridinium Chloride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
      "StrengthNumber": "10.5",
      "StrengthUnit": "mg/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-13",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0126-0023-14",
      "PackageDescription": "887 mL in 1 BOTTLE (0126-0023-14)",
      "NDC11Code": "00126-0023-14",
      "ProductNDC": "0126-0023",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate Total",
      "ProprietaryNameSuffix": "Freshmint",
      "NonProprietaryName": "Cetylpyridinium Chloride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
      "StrengthNumber": "10.5",
      "StrengthUnit": "mg/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-14",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0126-0024-14",
      "PackageDescription": "887 mL in 1 BOTTLE (0126-0024-14)",
      "NDC11Code": "00126-0024-14",
      "ProductNDC": "0126-0024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate Total",
      "ProprietaryNameSuffix": "Peppermint",
      "NonProprietaryName": "Cetylpyridinium Chloride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Colgate Oral Pharmaceuticals",
      "SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
      "StrengthNumber": "10.5",
      "StrengthUnit": "mg/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-13",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0126-0026-14",
      "PackageDescription": "887 mL in 1 BOTTLE (0126-0026-14)",
      "NDC11Code": "00126-0026-14",
      "ProductNDC": "0126-0026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate Total",
      "ProprietaryNameSuffix": "Whitening Sparklemint",
      "NonProprietaryName": "Cetylpyridinium Chloride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20100701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Colgate Oral Pharmaceuticals",
      "SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
      "StrengthNumber": "10.5",
      "StrengthUnit": "mg/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-20",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "49999-126-14",
      "PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (49999-126-14) ",
      "NDC11Code": "49999-0126-14",
      "ProductNDC": "49999-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120416",
      "EndMarketingDate": "20270531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062676",
      "LabelerName": "Quality Care Products, LLC",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120416",
      "EndMarketingDatePackage": "20270531",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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": "Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula. (C22H24N2O8HCl)2C2H6OH2O                                                    M.W. 1025.89. (C22H24N2O8HCl)2C2H6OH2O                                                    M.W. 1025.89. Each capsule for oral administration contains 50 mg or 100 mg doxycycline hyclate, equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, D&C Red #28, FD&C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains 100 mg doxycycline hyclate, equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide."
    },
    {
      "NDCCode": "52959-126-14",
      "PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (52959-126-14)",
      "NDC11Code": "52959-0126-14",
      "ProductNDC": "52959-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020712",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040256",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg."
    },
    {
      "NDCCode": "70934-126-14",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-126-14) ",
      "NDC11Code": "70934-0126-14",
      "ProductNDC": "70934-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190827",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205707",
      "LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
      "SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
      "StrengthNumber": "500; 125",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190827",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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. Amoxicillin and clavulanate potassium tablets USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.",
      "Description": "Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin, USP is ( 2S, 5R, 6R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. C 16H 19N 3O 5S3H 2O                M.W. 419.45 Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium, USP is potassium ( Z)-(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as:. C  8H  8KNO  5                             M.W. 237.25  Each tablet contains 250 mg, 500 mg or 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each Amoxicillin and Clavulanate Potassium Tablet USP contains 0.63 mEq potassium.  Inactive Ingredients: colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.  Meets USP Dissolution Test 1."
    },
    {
      "NDCCode": "71335-0126-2",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (71335-0126-2) ",
      "NDC11Code": "71335-0126-02",
      "ProductNDC": "71335-0126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Etodolac",
      "NonProprietaryName": "Etodolac",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076004",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "ETODOLAC",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240905",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:Osteoarthritis Rheumatoid arthritis , 2 For the management of acute pain .",
      "Description": "Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+] S and [-] R-enantiomers. Etodolac is a white or almost white crystalline powder, practically insoluble in water but freely soluble in acetone and in ethanol (96%). The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b] indole-1-acetic acid. The molecular weight of the base is 287.36. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each etodolac tablet, USP is for oral administration, contains 400 mg or 500 mg of etodolac. In addition, each tablet contains the following inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide."
    },
    {
      "NDCCode": "72578-126-14",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE (72578-126-14) ",
      "NDC11Code": "72578-0126-14",
      "ProductNDC": "72578-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ziprasidone",
      "NonProprietaryName": "Ziprasidone",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200915",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208988",
      "LabelerName": "Viona Pharmaceuticals Inc",
      "SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200915",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1   Ziprasidone is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].",
      "Description": "Ziprasidone capsule contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is an atypical antipsychotic available as capsules (ziprasidone hydrochloride) for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2  benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OS∙HCl∙H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate, USP is white to slightly pink powder; slightly soluble in methanol, methylene chloride, isopropyl alcohol and hot tetrahydrofuran, soluble in formic acid and practically insoluble in water and ethanol. Each capsule contains ziprasidone hydrochloride monohydrate 20 mg or 40 mg or 60 mg or 80 mg and inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch (botanical source: maize), sodium lauryl sulfate, titanium dioxide, water, FD & C Blue 1 (20 mg, 40 mg and 80 mg) and FD & C Red 40 (20 mg, 40 mg and 80 mg). Additionally, capsule shells of 20 mg, 40 mg and 80 mg are imprinted with white pharmaceutical ink and capsule shells of 60 mg are imprinted with black pharmaceutical ink. The compositions of the black and white pharmaceutical ink are: potassium hydroxide, propylene glycol, shellac, titanium dioxide and ferrosoferric oxide (black pharmaceutical ink). FDA approved drug release test specifications differ from USP."
    },
    {
      "NDCCode": "79903-126-14",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (79903-126-14)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "79903-0126-14",
      "ProductNDC": "79903-126",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equate Allergy Relief D Nasal Decongestant",
      "NonProprietaryName": "Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210719",
      "LabelerName": "WALMART INC.",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
      "StrengthNumber": "5; 120",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221001",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. nasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "10544-025-14",
      "PackageDescription": "14 CAPSULE in 1 BOTTLE (10544-025-14)",
      "NDC11Code": "10544-0025-14",
      "ProductNDC": "10544-025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101105",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065152",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cephalexin Capsule, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli. Proteus mirabilis, and Klebsiella pneumoniae. Note — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin Capsules, USP and other antibacterial drugs, Cephalexin Capsules, USP 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": "Cephalexin Capsule, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each 250-mg capsule contains cephalexin monohydrate equivalent to 250 mg of cephalexin and each 500-mg capsule contains cephalexin monohydrate equivalent to 500 mg of cephalexin. The inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc, colloidal silicone dioxide. The capsule shells contain gelatin, titanium dioxide, FD&C Blue No. 1, FD&C Yellow No. 5. The imprinting ink components on 250 mg and 500 mg capsules: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide."
    },
    {
      "NDCCode": "10695-025-14",
      "PackageDescription": "100 g in 1 BOTTLE (10695-025-14)",
      "NDC11Code": "10695-0025-14",
      "ProductNDC": "10695-025",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Fluticasone Propionate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20141105",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Willow Birch Pharma",
      "SubstanceName": "FLUTICASONE PROPIONATE",
      "StrengthNumber": "100",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "15054-0025-1",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (15054-0025-1)  / 14 CAPSULE in 1 BLISTER PACK",
      "NDC11Code": "15054-0025-01",
      "ProductNDC": "15054-0025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sohonos",
      "NonProprietaryName": "Palovarotene",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230816",
      "EndMarketingDate": "20270430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA215559",
      "LabelerName": "Ipsen Biopharmaceuticals, Inc.",
      "SubstanceName": "PALOVAROTENE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230816",
      "EndMarketingDatePackage": "20270430",
      "SamplePackage": "N",
      "IndicationAndUsage": "SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).",
      "Description": "Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac."
    },
    {
      "NDCCode": "17312-025-14",
      "PackageDescription": "1 BOTTLE in 1 PACKAGE (17312-025-14)  / 70 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE",
      "NDC11Code": "17312-0025-14",
      "ProductNDC": "17312-025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Earache Relief",
      "NonProprietaryName": "Apis Mellifera, Arnica Montana, Atropa Belladonna, Tribasic Calcium Phosphate, Echinacea, Unspecified, Calcium Sulfide, Mercurius Solubilis",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130905",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "TRP Company",
      "SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; ECHINACEA, UNSPECIFIED; CALCIUM SULFIDE; MERCURIUS SOLUBILIS",
      "StrengthNumber": "6; 6; 6; 6; 3; 6; 6",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Standardized Insect Venom Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20150428",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "36800-025-14",
      "PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (36800-025-14)",
      "NDC11Code": "36800-0025-14",
      "ProductNDC": "36800-025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Topcare",
      "ProprietaryNameSuffix": "2 In 1 Dandruff Dry Scalp",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140728",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358H",
      "LabelerName": "TOPCO ASSOCIATES LLC",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF."
    },
    {
      "NDCCode": "50019-025-14",
      "PackageDescription": "250 g in 1 DRUM (50019-025-14)",
      "NDC11Code": "50019-0025-14",
      "ProductNDC": "50019-025",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Clenbuterol Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20021201",
      "EndMarketingDate": "20210521",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Boehringer Ingelheim Chemicals, Inc.",
      "SubstanceName": "CLENBUTEROL HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "51862-025-14",
      "PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (51862-025-14)",
      "NDC11Code": "51862-0025-14",
      "ProductNDC": "51862-025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dofetilide",
      "NonProprietaryName": "Dofetilide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160607",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207058",
      "LabelerName": "Mayne Pharma Inc.",
      "SubstanceName": "DOFETILIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "58232-0025-1",
      "PackageDescription": "14 g in 1 TUBE (58232-0025-1)",
      "NDC11Code": "58232-0025-01",
      "ProductNDC": "58232-0025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aveeno Active Naturals Hydrosport Sunblock",
      "ProprietaryNameSuffix": "Spf 85",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20101015",
      "EndMarketingDate": "20161201",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "28.8; 67.3; 48.1; 96.2; 57.7",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "60760-025-14",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-025-14) ",
      "NDC11Code": "60760-0025-14",
      "ProductNDC": "60760-025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranitidine",
      "NonProprietaryName": "Ranitidine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151204",
      "EndMarketingDate": "20220228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078542",
      "LabelerName": "St. Mary's Medical Park Pharmacy",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180320",
      "EndMarketingDatePackage": "20220228",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-025-14",
      "PackageDescription": "28 g in 1 BOTTLE, PLASTIC (68428-025-14) ",
      "NDC11Code": "68428-0025-14",
      "ProductNDC": "68428-025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stop Smoking",
      "NonProprietaryName": "Dieffenbachia Seguine - Daphne Odora Bark - Strychnos Nux-vomica Seed - Plantago Major - Delphinium Staphisagria Seed - Tobacco Leaf",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100402",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF",
      "StrengthNumber": "6; 6; 6; 6; 6; 6",
      "StrengthUnit": "[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g",
      "Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20100402",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indications:. CALADIUM    Motion sickness. DAPHNE    Bad breath. NUX VOM   Vomiting. PLANTAGO       Earache. STAPHYSAG    Anger. TABACUM     Sea sickness."
    },
    {
      "NDCCode": "69423-025-14",
      "PackageDescription": "14 g in 1 CYLINDER (69423-025-14)",
      "NDC11Code": "69423-0025-14",
      "ProductNDC": "69423-025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Secret Scent Expressions Clear Va Va Vanilla",
      "NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150323",
      "EndMarketingDate": "20171114",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Procter and Gamble Manufacturing Company",
      "SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2017-11-15"
    },
    {
      "NDCCode": "69804-025-14",
      "PackageDescription": "28500 mg in 1 BOTTLE, DISPENSING (69804-025-14)",
      "NDC11Code": "69804-0025-14",
      "ProductNDC": "69804-025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Extra Strength Liquid Insect Bite Relief Gel",
      "NonProprietaryName": "Lidocaine Hcl",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170113",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "ridge properties",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1000mg",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "71042-025-14",
      "PackageDescription": "1 TUBE in 1 CARTON (71042-025-14)  / 14.2 g in 1 TUBE",
      "NDC11Code": "71042-0025-14",
      "ProductNDC": "71042-025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Femiclear Bacterial Vaginosis Symptoms",
      "NonProprietaryName": "Thymol With Olive Extract",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220601",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Organicare Nature's Science, LLC",
      "SubstanceName": "THYMOL; OLEA EUROPAEA FRUIT VOLATILE OIL",
      "StrengthNumber": "6; 3",
      "StrengthUnit": "[hp_X]/100g; [hp_X]/100g",
      "Status": "Active",
      "LastUpdate": "2025-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220601",
      "SamplePackage": "N",
      "IndicationAndUsage": "This product is intended to relieve symptoms associated with known bacterial vaginosis infecions, including fishy odor, excess discharge, irritation and burning while urinating."
    },
    {
      "NDCCode": "72988-0025-1",
      "PackageDescription": "14 g in 1 POUCH (72988-0025-1) ",
      "NDC11Code": "72988-0025-01",
      "ProductNDC": "72988-0025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Zenol Mild Hot",
      "NonProprietaryName": "Methyl Salicylate, Vanillyl Nonylamide",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20211001",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Lydia Co., Ltd.",
      "SubstanceName": "METHYL SALICYLATE; NONIVAMIDE",
      "StrengthNumber": "105; 1.75",
      "StrengthUnit": "mg/14g; mg/14g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20211001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adults and children 12 years of age and over. Clean and dry affected area Remove patch from film. Apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most 8-hour application. Children under 12 years of age."
    },
    {
      "NDCCode": "82982-025-14",
      "PackageDescription": "14 TABLET, COATED in 1 BOTTLE (82982-025-14) ",
      "NDC11Code": "82982-0025-14",
      "ProductNDC": "82982-025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ciprofloxacin",
      "NonProprietaryName": "Ciprofloxacin",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230206",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208921",
      "LabelerName": "Pharmasource Meds, LLC",
      "SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230206",
      "SamplePackage": "N",
      "Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in a 500 mg (ciprofloxacin equivalent) strength. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG."
    },
    {
      "NDCCode": "84053-025-14",
      "PackageDescription": "14 TABLET in 1 BOTTLE (84053-025-14) ",
      "NDC11Code": "84053-0025-14",
      "ProductNDC": "84053-025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phentermine Hydrochloride",
      "NonProprietaryName": "Phentermine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040876",
      "LabelerName": "Martek Pharmacal Co.",
      "SubstanceName": "PHENTERMINE HYDROCHLORIDE",
      "StrengthNumber": "37.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phentermine hydrochloride, USP 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
      "Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, FD&C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, stearic acid, and sucrose."
    },
    {
      "NDCCode": "0126-0021-03",
      "PackageDescription": "59 mL in 1 BOTTLE (0126-0021-03)",
      "NDC11Code": "00126-0021-03",
      "ProductNDC": "0126-0021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate",
      "ProprietaryNameSuffix": "Dry Mouth Relief",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "RINSE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20110114",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.1",
      "StrengthUnit": "mg/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-14",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "0126-0021-16",
      "PackageDescription": "473 mL in 1 BOTTLE (0126-0021-16)",
      "NDC11Code": "00126-0021-16",
      "ProductNDC": "0126-0021",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Colgate",
      "ProprietaryNameSuffix": "Dry Mouth Relief",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "RINSE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20110114",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Colgate Oral Pharmaceuticals, Inc.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.1",
      "StrengthUnit": "mg/10mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-14",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"0126-0025-14","ProprietaryName":"Colgate Total","NonProprietaryName":"Cetylpyridinium Chloride"},{"NDCCode":"0126-0025-08","ProprietaryName":"Colgate Total","NonProprietaryName":"Cetylpyridinium Chloride"},{"NDCCode":"0126-0025-16","ProprietaryName":"Colgate Total","NonProprietaryName":"Cetylpyridinium Chloride"},{"NDCCode":"0126-0023-14","ProprietaryName":"Colgate Total","NonProprietaryName":"Cetylpyridinium Chloride"},{"NDCCode":"0126-0024-14","ProprietaryName":"Colgate Total","NonProprietaryName":"Cetylpyridinium Chloride"},{"NDCCode":"0126-0026-14","ProprietaryName":"Colgate Total","NonProprietaryName":"Cetylpyridinium Chloride"},{"NDCCode":"49999-126-14","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"52959-126-14","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"70934-126-14","ProprietaryName":"Amoxicillin And Clavulanate Potassium","NonProprietaryName":"Amoxicillin And Clavulanate Potassium"},{"NDCCode":"71335-0126-2","ProprietaryName":"Etodolac","NonProprietaryName":"Etodolac"},{"NDCCode":"72578-126-14","ProprietaryName":"Ziprasidone","NonProprietaryName":"Ziprasidone"},{"NDCCode":"79903-126-14","ProprietaryName":"Equate Allergy Relief D Nasal Decongestant","NonProprietaryName":"Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride"},{"NDCCode":"10544-025-14","ProprietaryName":"Cephalexin","NonProprietaryName":"Cephalexin"},{"NDCCode":"10695-025-14","NonProprietaryName":"Fluticasone Propionate"},{"NDCCode":"15054-0025-1","ProprietaryName":"Sohonos","NonProprietaryName":"Palovarotene"},{"NDCCode":"17312-025-14","ProprietaryName":"Earache Relief","NonProprietaryName":"Apis Mellifera, Arnica Montana, Atropa Belladonna, Tribasic Calcium Phosphate, Echinacea, Unspecified, Calcium Sulfide, Mercurius Solubilis"},{"NDCCode":"36800-025-14","ProprietaryName":"Topcare","NonProprietaryName":"Pyrithione Zinc"},{"NDCCode":"50019-025-14","NonProprietaryName":"Clenbuterol Hydrochloride"},{"NDCCode":"51862-025-14","ProprietaryName":"Dofetilide","NonProprietaryName":"Dofetilide"},{"NDCCode":"58232-0025-1","ProprietaryName":"Aveeno Active Naturals Hydrosport Sunblock","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone"},{"NDCCode":"60760-025-14","ProprietaryName":"Ranitidine","NonProprietaryName":"Ranitidine"},{"NDCCode":"68428-025-14","ProprietaryName":"Stop Smoking","NonProprietaryName":"Dieffenbachia Seguine - Daphne Odora Bark - Strychnos Nux-vomica Seed - Plantago Major - Delphinium Staphisagria Seed - Tobacco Leaf"},{"NDCCode":"69423-025-14","ProprietaryName":"Secret Scent Expressions Clear Va Va Vanilla","NonProprietaryName":"Aluminum Zirconium Octachlorohydrex Gly"},{"NDCCode":"69804-025-14","ProprietaryName":"Extra Strength Liquid Insect Bite Relief Gel","NonProprietaryName":"Lidocaine Hcl"},{"NDCCode":"71042-025-14","ProprietaryName":"Femiclear Bacterial Vaginosis Symptoms","NonProprietaryName":"Thymol With Olive Extract"},{"NDCCode":"72988-0025-1","ProprietaryName":"Zenol Mild Hot","NonProprietaryName":"Methyl Salicylate, Vanillyl Nonylamide"},{"NDCCode":"82982-025-14","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin"},{"NDCCode":"84053-025-14","ProprietaryName":"Phentermine Hydrochloride","NonProprietaryName":"Phentermine Hydrochloride"},{"NDCCode":"0126-0021-03","ProprietaryName":"Colgate","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"0126-0021-16","ProprietaryName":"Colgate","NonProprietaryName":"Sodium Fluoride"}]}
                    

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    <ProductNDC>0126-0025</ProductNDC>
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    <ProprietaryName>Colgate Total</ProprietaryName>
    <ProprietaryNameSuffix>Gentle Care Softmint</ProprietaryNameSuffix>
    <NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
    <StrengthNumber>10.5</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
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    <PackageDescription>236 mL in 1 BOTTLE (0126-0025-08)</PackageDescription>
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    <ProductNDC>0126-0025</ProductNDC>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
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    <LastUpdate>2019-09-13</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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    <ProprietaryName>Colgate Total</ProprietaryName>
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    <DosageFormName>MOUTHWASH</DosageFormName>
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    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
    <StrengthNumber>10.5</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-13</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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    <PackageDescription>887 mL in 1 BOTTLE (0126-0023-14)</PackageDescription>
    <NDC11Code>00126-0023-14</NDC11Code>
    <ProductNDC>0126-0023</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Colgate Total</ProprietaryName>
    <ProprietaryNameSuffix>Freshmint</ProprietaryNameSuffix>
    <NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20100701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
    <StrengthNumber>10.5</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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    <PackageDescription>887 mL in 1 BOTTLE (0126-0024-14)</PackageDescription>
    <NDC11Code>00126-0024-14</NDC11Code>
    <ProductNDC>0126-0024</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Colgate Total</ProprietaryName>
    <ProprietaryNameSuffix>Peppermint</ProprietaryNameSuffix>
    <NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20100701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Colgate Oral Pharmaceuticals</LabelerName>
    <SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
    <StrengthNumber>10.5</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-13</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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    <NDCCode>0126-0026-14</NDCCode>
    <PackageDescription>887 mL in 1 BOTTLE (0126-0026-14)</PackageDescription>
    <NDC11Code>00126-0026-14</NDC11Code>
    <ProductNDC>0126-0026</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Colgate Total</ProprietaryName>
    <ProprietaryNameSuffix>Whitening Sparklemint</ProprietaryNameSuffix>
    <NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20100701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Colgate Oral Pharmaceuticals</LabelerName>
    <SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
    <StrengthNumber>10.5</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-20</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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  <NDC>
    <NDCCode>49999-126-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (49999-126-14) </PackageDescription>
    <NDC11Code>49999-0126-14</NDC11Code>
    <ProductNDC>49999-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120416</StartMarketingDate>
    <EndMarketingDate>20270531</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062676</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120416</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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>Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Doxycycline hyclate has the following structural formula. (C22H24N2O8HCl)2C2H6OH2O                                                    M.W. 1025.89. (C22H24N2O8HCl)2C2H6OH2O                                                    M.W. 1025.89. Each capsule for oral administration contains 50 mg or 100 mg doxycycline hyclate, equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, D&amp;C Red #28, FD&amp;C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains 100 mg doxycycline hyclate, equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&amp;C Yellow #10 aluminum lake, FD&amp;C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>52959-126-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (52959-126-14)</PackageDescription>
    <NDC11Code>52959-0126-14</NDC11Code>
    <ProductNDC>52959-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020712</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040256</ApplicationNumber>
    <LabelerName>H.J. Harkins Company, Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.</Description>
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    <NDCCode>70934-126-14</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-126-14) </PackageDescription>
    <NDC11Code>70934-0126-14</NDC11Code>
    <ProductNDC>70934-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
    <NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190827</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205707</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
    <StrengthNumber>500; 125</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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. Amoxicillin and clavulanate potassium tablets USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.</IndicationAndUsage>
    <Description>Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin, USP is ( 2S, 5R, 6R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. C 16H 19N 3O 5S3H 2O                M.W. 419.45 Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium, USP is potassium ( Z)-(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as:. C  8H  8KNO  5                             M.W. 237.25  Each tablet contains 250 mg, 500 mg or 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each Amoxicillin and Clavulanate Potassium Tablet USP contains 0.63 mEq potassium.  Inactive Ingredients: colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.  Meets USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0126-2</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (71335-0126-2) </PackageDescription>
    <NDC11Code>71335-0126-02</NDC11Code>
    <ProductNDC>71335-0126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Etodolac</ProprietaryName>
    <NonProprietaryName>Etodolac</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20030501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076004</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ETODOLAC</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac tablets, USP are indicated: 1 For acute and long-term use in the management of signs and symptoms of the following:Osteoarthritis Rheumatoid arthritis , 2 For the management of acute pain .</IndicationAndUsage>
    <Description>Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+] S and [-] R-enantiomers. Etodolac is a white or almost white crystalline powder, practically insoluble in water but freely soluble in acetone and in ethanol (96%). The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b] indole-1-acetic acid. The molecular weight of the base is 287.36. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C17H21NO3, and it has the following structural formula. Each etodolac tablet, USP is for oral administration, contains 400 mg or 500 mg of etodolac. In addition, each tablet contains the following inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72578-126-14</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (72578-126-14) </PackageDescription>
    <NDC11Code>72578-0126-14</NDC11Code>
    <ProductNDC>72578-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ziprasidone</ProprietaryName>
    <NonProprietaryName>Ziprasidone</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208988</ApplicationNumber>
    <LabelerName>Viona Pharmaceuticals Inc</LabelerName>
    <SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia: 1   Ziprasidone is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].</IndicationAndUsage>
    <Description>Ziprasidone capsule contains the active moiety, ziprasidone, in the form of ziprasidone hydrochloride salt. Ziprasidone is an atypical antipsychotic available as capsules (ziprasidone hydrochloride) for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. Ziprasidone capsules, USP contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2  benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The molecular formula is C21H21ClN4OS∙HCl∙H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate, USP is white to slightly pink powder; slightly soluble in methanol, methylene chloride, isopropyl alcohol and hot tetrahydrofuran, soluble in formic acid and practically insoluble in water and ethanol. Each capsule contains ziprasidone hydrochloride monohydrate 20 mg or 40 mg or 60 mg or 80 mg and inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch (botanical source: maize), sodium lauryl sulfate, titanium dioxide, water, FD &amp; C Blue 1 (20 mg, 40 mg and 80 mg) and FD &amp; C Red 40 (20 mg, 40 mg and 80 mg). Additionally, capsule shells of 20 mg, 40 mg and 80 mg are imprinted with white pharmaceutical ink and capsule shells of 60 mg are imprinted with black pharmaceutical ink. The compositions of the black and white pharmaceutical ink are: potassium hydroxide, propylene glycol, shellac, titanium dioxide and ferrosoferric oxide (black pharmaceutical ink). FDA approved drug release test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>79903-126-14</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (79903-126-14)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>79903-0126-14</NDC11Code>
    <ProductNDC>79903-126</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equate Allergy Relief D Nasal Decongestant</ProprietaryName>
    <NonProprietaryName>Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210719</ApplicationNumber>
    <LabelerName>WALMART INC.</LabelerName>
    <SubstanceName>CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5; 120</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. nasal congestion. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10544-025-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE (10544-025-14)</PackageDescription>
    <NDC11Code>10544-0025-14</NDC11Code>
    <ProductNDC>10544-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cephalexin</ProprietaryName>
    <NonProprietaryName>Cephalexin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101105</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065152</ApplicationNumber>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>CEPHALEXIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Cephalexin Capsule, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli. Proteus mirabilis, and Klebsiella pneumoniae. Note — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin Capsules, USP and other antibacterial drugs, Cephalexin Capsules, USP 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>Cephalexin Capsule, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each 250-mg capsule contains cephalexin monohydrate equivalent to 250 mg of cephalexin and each 500-mg capsule contains cephalexin monohydrate equivalent to 500 mg of cephalexin. The inactive ingredients: magnesium stearate, sodium starch glycolate, lactose monohydrate, talc, colloidal silicone dioxide. The capsule shells contain gelatin, titanium dioxide, FD&amp;C Blue No. 1, FD&amp;C Yellow No. 5. The imprinting ink components on 250 mg and 500 mg capsules: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10695-025-14</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE (10695-025-14)</PackageDescription>
    <NDC11Code>10695-0025-14</NDC11Code>
    <ProductNDC>10695-025</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20141105</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Willow Birch Pharma</LabelerName>
    <SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>15054-0025-1</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (15054-0025-1)  / 14 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>15054-0025-01</NDC11Code>
    <ProductNDC>15054-0025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sohonos</ProprietaryName>
    <NonProprietaryName>Palovarotene</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230816</StartMarketingDate>
    <EndMarketingDate>20270430</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215559</ApplicationNumber>
    <LabelerName>Ipsen Biopharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PALOVAROTENE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20230816</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).</IndicationAndUsage>
    <Description>Palovarotene is an orally bioavailable retinoid that acts as a retinoic acid receptor (RAR) agonist with particular selectivity at the gamma subtype of RAR. Palovarotene is chemically described as 4-[(E)-2-(5,5,8,8-tetramethyl-3-pyrazol-1-ylmethyl-5,6,7,8-tetrahydro-naphthalen-2-yl)-vinyl]-benzoic acid with an empirical formula of C27H30N2O2 and has a molecular weight of 414.54 g/mol. The structural formula is represented below. SOHONOS capsules are supplied in 1 mg, 1.5 mg, 5 mg and 10 mg strengths. Each capsule contains palovarotene as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The capsule consists of gelatin and titanium dioxide. The black printing ink consists of black iron oxide, potassium hydroxide, propylene glycol and Shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>17312-025-14</NDCCode>
    <PackageDescription>1 BOTTLE in 1 PACKAGE (17312-025-14)  / 70 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
    <NDC11Code>17312-0025-14</NDC11Code>
    <ProductNDC>17312-025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Earache Relief</ProprietaryName>
    <NonProprietaryName>Apis Mellifera, Arnica Montana, Atropa Belladonna, Tribasic Calcium Phosphate, Echinacea, Unspecified, Calcium Sulfide, Mercurius Solubilis</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130905</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>TRP Company</LabelerName>
    <SubstanceName>APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; ECHINACEA, UNSPECIFIED; CALCIUM SULFIDE; MERCURIUS SOLUBILIS</SubstanceName>
    <StrengthNumber>6; 6; 6; 6; 3; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Bee Venoms [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150428</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>36800-025-14</NDCCode>
    <PackageDescription>420 mL in 1 BOTTLE, PLASTIC (36800-025-14)</PackageDescription>
    <NDC11Code>36800-0025-14</NDC11Code>
    <ProductNDC>36800-025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Topcare</ProprietaryName>
    <ProprietaryNameSuffix>2 In 1 Dandruff Dry Scalp</ProprietaryNameSuffix>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140728</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50019-025-14</NDCCode>
    <PackageDescription>250 g in 1 DRUM (50019-025-14)</PackageDescription>
    <NDC11Code>50019-0025-14</NDC11Code>
    <ProductNDC>50019-025</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Clenbuterol Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20021201</StartMarketingDate>
    <EndMarketingDate>20210521</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Boehringer Ingelheim Chemicals, Inc.</LabelerName>
    <SubstanceName>CLENBUTEROL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51862-025-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (51862-025-14)</PackageDescription>
    <NDC11Code>51862-0025-14</NDC11Code>
    <ProductNDC>51862-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dofetilide</ProprietaryName>
    <NonProprietaryName>Dofetilide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160607</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207058</ApplicationNumber>
    <LabelerName>Mayne Pharma Inc.</LabelerName>
    <SubstanceName>DOFETILIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58232-0025-1</NDCCode>
    <PackageDescription>14 g in 1 TUBE (58232-0025-1)</PackageDescription>
    <NDC11Code>58232-0025-01</NDC11Code>
    <ProductNDC>58232-0025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aveeno Active Naturals Hydrosport Sunblock</ProprietaryName>
    <ProprietaryNameSuffix>Spf 85</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20101015</StartMarketingDate>
    <EndMarketingDate>20161201</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Products Company, Division of Johnson &amp; Johnson Consumer Companies, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>28.8; 67.3; 48.1; 96.2; 57.7</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>60760-025-14</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-025-14) </PackageDescription>
    <NDC11Code>60760-0025-14</NDC11Code>
    <ProductNDC>60760-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine</ProprietaryName>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151204</StartMarketingDate>
    <EndMarketingDate>20220228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078542</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180320</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68428-025-14</NDCCode>
    <PackageDescription>28 g in 1 BOTTLE, PLASTIC (68428-025-14) </PackageDescription>
    <NDC11Code>68428-0025-14</NDC11Code>
    <ProductNDC>68428-025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stop Smoking</ProprietaryName>
    <NonProprietaryName>Dieffenbachia Seguine - Daphne Odora Bark - Strychnos Nux-vomica Seed - Plantago Major - Delphinium Staphisagria Seed - Tobacco Leaf</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100402</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF</SubstanceName>
    <StrengthNumber>6; 6; 6; 6; 6; 6</StrengthNumber>
    <StrengthUnit>[hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Indications:. CALADIUM    Motion sickness. DAPHNE    Bad breath. NUX VOM   Vomiting. PLANTAGO       Earache. STAPHYSAG    Anger. TABACUM     Sea sickness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69423-025-14</NDCCode>
    <PackageDescription>14 g in 1 CYLINDER (69423-025-14)</PackageDescription>
    <NDC11Code>69423-0025-14</NDC11Code>
    <ProductNDC>69423-025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Secret Scent Expressions Clear Va Va Vanilla</ProprietaryName>
    <NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150323</StartMarketingDate>
    <EndMarketingDate>20171114</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Procter and Gamble Manufacturing Company</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-11-15</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>69804-025-14</NDCCode>
    <PackageDescription>28500 mg in 1 BOTTLE, DISPENSING (69804-025-14)</PackageDescription>
    <NDC11Code>69804-0025-14</NDC11Code>
    <ProductNDC>69804-025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Extra Strength Liquid Insect Bite Relief Gel</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170113</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>ridge properties</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1000mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>71042-025-14</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (71042-025-14)  / 14.2 g in 1 TUBE</PackageDescription>
    <NDC11Code>71042-0025-14</NDC11Code>
    <ProductNDC>71042-025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Femiclear Bacterial Vaginosis Symptoms</ProprietaryName>
    <NonProprietaryName>Thymol With Olive Extract</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220601</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Organicare Nature's Science, LLC</LabelerName>
    <SubstanceName>THYMOL; OLEA EUROPAEA FRUIT VOLATILE OIL</SubstanceName>
    <StrengthNumber>6; 3</StrengthNumber>
    <StrengthUnit>[hp_X]/100g; [hp_X]/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This product is intended to relieve symptoms associated with known bacterial vaginosis infecions, including fishy odor, excess discharge, irritation and burning while urinating.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72988-0025-1</NDCCode>
    <PackageDescription>14 g in 1 POUCH (72988-0025-1) </PackageDescription>
    <NDC11Code>72988-0025-01</NDC11Code>
    <ProductNDC>72988-0025</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zenol Mild Hot</ProprietaryName>
    <NonProprietaryName>Methyl Salicylate, Vanillyl Nonylamide</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20211001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Lydia Co., Ltd.</LabelerName>
    <SubstanceName>METHYL SALICYLATE; NONIVAMIDE</SubstanceName>
    <StrengthNumber>105; 1.75</StrengthNumber>
    <StrengthUnit>mg/14g; mg/14g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adults and children 12 years of age and over. Clean and dry affected area Remove patch from film. Apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most 8-hour application. Children under 12 years of age.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82982-025-14</NDCCode>
    <PackageDescription>14 TABLET, COATED in 1 BOTTLE (82982-025-14) </PackageDescription>
    <NDC11Code>82982-0025-14</NDC11Code>
    <ProductNDC>82982-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208921</ApplicationNumber>
    <LabelerName>Pharmasource Meds, LLC</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in a 500 mg (ciprofloxacin equivalent) strength. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
  </NDC>
  <NDC>
    <NDCCode>84053-025-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BOTTLE (84053-025-14) </PackageDescription>
    <NDC11Code>84053-0025-14</NDC11Code>
    <ProductNDC>84053-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040876</ApplicationNumber>
    <LabelerName>Martek Pharmacal Co.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phentermine hydrochloride, USP 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
    <Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, FD&amp;C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, stearic acid, and sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>0126-0021-03</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE (0126-0021-03)</PackageDescription>
    <NDC11Code>00126-0021-03</NDC11Code>
    <ProductNDC>0126-0021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Colgate</ProprietaryName>
    <ProprietaryNameSuffix>Dry Mouth Relief</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>RINSE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20110114</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.1</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0126-0021-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (0126-0021-16)</PackageDescription>
    <NDC11Code>00126-0021-16</NDC11Code>
    <ProductNDC>0126-0021</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Colgate</ProprietaryName>
    <ProprietaryNameSuffix>Dry Mouth Relief</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>RINSE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20110114</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Colgate Oral Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.1</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-14</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0126-0025-14</NDCCode><ProprietaryName>Colgate Total</ProprietaryName><NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0126-0025-08</NDCCode><ProprietaryName>Colgate Total</ProprietaryName><NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0126-0025-16</NDCCode><ProprietaryName>Colgate Total</ProprietaryName><NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0126-0023-14</NDCCode><ProprietaryName>Colgate Total</ProprietaryName><NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0126-0024-14</NDCCode><ProprietaryName>Colgate Total</ProprietaryName><NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0126-0026-14</NDCCode><ProprietaryName>Colgate Total</ProprietaryName><NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName></NDC><NDC><NDCCode>49999-126-14</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>52959-126-14</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>70934-126-14</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>71335-0126-2</NDCCode><ProprietaryName>Etodolac</ProprietaryName><NonProprietaryName>Etodolac</NonProprietaryName></NDC><NDC><NDCCode>72578-126-14</NDCCode><ProprietaryName>Ziprasidone</ProprietaryName><NonProprietaryName>Ziprasidone</NonProprietaryName></NDC><NDC><NDCCode>79903-126-14</NDCCode><ProprietaryName>Equate Allergy Relief D Nasal Decongestant</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10544-025-14</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC><NDC><NDCCode>10695-025-14</NDCCode><NonProprietaryName>Fluticasone Propionate</NonProprietaryName></NDC><NDC><NDCCode>15054-0025-1</NDCCode><ProprietaryName>Sohonos</ProprietaryName><NonProprietaryName>Palovarotene</NonProprietaryName></NDC><NDC><NDCCode>17312-025-14</NDCCode><ProprietaryName>Earache Relief</ProprietaryName><NonProprietaryName>Apis Mellifera, Arnica Montana, Atropa Belladonna, Tribasic Calcium Phosphate, Echinacea, Unspecified, Calcium Sulfide, Mercurius Solubilis</NonProprietaryName></NDC><NDC><NDCCode>36800-025-14</NDCCode><ProprietaryName>Topcare</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>50019-025-14</NDCCode><NonProprietaryName>Clenbuterol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51862-025-14</NDCCode><ProprietaryName>Dofetilide</ProprietaryName><NonProprietaryName>Dofetilide</NonProprietaryName></NDC><NDC><NDCCode>58232-0025-1</NDCCode><ProprietaryName>Aveeno Active Naturals Hydrosport Sunblock</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>60760-025-14</NDCCode><ProprietaryName>Ranitidine</ProprietaryName><NonProprietaryName>Ranitidine</NonProprietaryName></NDC><NDC><NDCCode>68428-025-14</NDCCode><ProprietaryName>Stop Smoking</ProprietaryName><NonProprietaryName>Dieffenbachia Seguine - Daphne Odora Bark - Strychnos Nux-vomica Seed - Plantago Major - Delphinium Staphisagria Seed - Tobacco Leaf</NonProprietaryName></NDC><NDC><NDCCode>69423-025-14</NDCCode><ProprietaryName>Secret Scent Expressions Clear Va Va Vanilla</ProprietaryName><NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>69804-025-14</NDCCode><ProprietaryName>Extra Strength Liquid Insect Bite Relief Gel</ProprietaryName><NonProprietaryName>Lidocaine Hcl</NonProprietaryName></NDC><NDC><NDCCode>71042-025-14</NDCCode><ProprietaryName>Femiclear Bacterial Vaginosis Symptoms</ProprietaryName><NonProprietaryName>Thymol With Olive Extract</NonProprietaryName></NDC><NDC><NDCCode>72988-0025-1</NDCCode><ProprietaryName>Zenol Mild Hot</ProprietaryName><NonProprietaryName>Methyl Salicylate, Vanillyl Nonylamide</NonProprietaryName></NDC><NDC><NDCCode>82982-025-14</NDCCode><ProprietaryName>Ciprofloxacin</ProprietaryName><NonProprietaryName>Ciprofloxacin</NonProprietaryName></NDC><NDC><NDCCode>84053-025-14</NDCCode><ProprietaryName>Phentermine Hydrochloride</ProprietaryName><NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0126-0021-03</NDCCode><ProprietaryName>Colgate</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>0126-0021-16</NDCCode><ProprietaryName>Colgate</ProprietaryName><NonProprietaryName>Sodium Fluoride</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",
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      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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