RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "0178-0891-10",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (0178-0891-10)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "00178-0891-10",
      "ProductNDC": "0178-0891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Citranatal Assure",
      "NonProprietaryName": "Ascorbic Acid, Calcium Citrate, Iron, Vitamin D, Dl- Alpha- Tocopherol Acetate, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Doconexent And Icosapent",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20140430",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "Status": "Deprecated",
      "LastUpdate": "2022-10-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20140430",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0178-0891-30",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (0178-0891-30)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "00178-0891-30",
      "ProductNDC": "0178-0891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Citranatal Assure",
      "NonProprietaryName": "Ascorbic Acid, Calcium Citrate, Iron, Vitamin D, Dl- Alpha- Tocopherol Acetate, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Doconexent And Icosapent",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20140430",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140430",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0121-0891-20",
      "PackageDescription": "2 TRAY in 1 CASE (0121-0891-20)  > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0891-05) ",
      "NDC11Code": "00121-0891-20",
      "ProductNDC": "0121-0891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Felbamate",
      "NonProprietaryName": "Felbamate",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170616",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206314",
      "LabelerName": "Pharmaceutical Associates, Inc.",
      "SubstanceName": "FELBAMATE",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200521",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "23155-891-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (23155-891-10) ",
      "NDC11Code": "23155-0891-10",
      "ProductNDC": "23155-891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lurasidone Hydrochloride",
      "NonProprietaryName": "Lurasidone Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20231019",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA208058",
      "LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
      "SubstanceName": "LURASIDONE HYDROCHLORIDE",
      "StrengthNumber": "120",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250820",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].",
      "Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-­ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch and titanium dioxide."
    },
    {
      "NDCCode": "33261-891-10",
      "PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (33261-891-10)",
      "NDC11Code": "33261-0891-10",
      "ProductNDC": "33261-891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110620",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090367",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13), 9 Plague (1.14).",
      "Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin is a white to light yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3>Cu+2>Zn+2>Mg+2>Ca+2. Excipients and Description of Dosage Forms. Levofloxacin Tablets. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: : 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide,  hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol,  polysorbate 80, povidone, propylene glycol, sodium starch glycolate and titanium dioxide., 2 500 mg (as expressed in the anhydrous form):  colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol,  sodium starch glycolate and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, hypromellose,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol, sodium starch glycolate and titanium dioxide."
    },
    {
      "NDCCode": "37000-891-10",
      "PackageDescription": "2 CARTON in 1 CELLO PACK (37000-891-10)  / 1 TUBE in 1 CARTON / 144 g in 1 TUBE",
      "NDC11Code": "37000-0891-10",
      "ProductNDC": "37000-891",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Crest Pro-health Advanced",
      "NonProprietaryName": "Stannous Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20161229",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "STANNOUS FLUORIDE",
      "StrengthNumber": "1.6",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20161229",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact."
    },
    {
      "NDCCode": "43598-891-10",
      "PackageDescription": "100 CUP, UNIT-DOSE in 1 PACKAGE (43598-891-10)  > 15 mL in 1 CUP, UNIT-DOSE (43598-891-16) ",
      "NDC11Code": "43598-0891-10",
      "ProductNDC": "43598-891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride",
      "NonProprietaryName": "Potassium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220725",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213062",
      "LabelerName": "Dr. Reddy�s Laboratories, Inc.",
      "SubstanceName": "POTASSIUM CHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "meq/15mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220725",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Chloride Oral Solution, USP is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
      "Description": "Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution: 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
    },
    {
      "NDCCode": "43744-891-10",
      "PackageDescription": "1 g in 1 DRUM (43744-891-10)",
      "NDC11Code": "43744-0891-10",
      "ProductNDC": "43744-891",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20120103",
      "EndMarketingDate": "20130624",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130624"
    },
    {
      "NDCCode": "49288-0891-3",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0891-3)",
      "NDC11Code": "49288-0891-03",
      "ProductNDC": "49288-0891",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Treatment Set Ts348335",
      "NonProprietaryName": "Treatment Set Ts348335",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19861031",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102223",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "PERIPLANETA AMERICANA; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS",
      "StrengthNumber": ".002; .002; .01; .01; .01; .01",
      "StrengthUnit": "g/mL; g/mL; g/mL; g/mL; g/mL; g/mL",
      "Pharm_Classes": "Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11. THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.",
      "Description": "Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified. Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial. Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery."
    },
    {
      "NDCCode": "49349-891-10",
      "PackageDescription": "6 TABLET in 1 BOTTLE (49349-891-10)",
      "NDC11Code": "49349-0891-10",
      "ProductNDC": "49349-891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078218",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "54458-891-10",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (54458-891-10) ",
      "NDC11Code": "54458-0891-10",
      "ProductNDC": "54458-891",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Escitalopram",
      "NonProprietaryName": "Escitalopram",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076765",
      "LabelerName": "International Laboratories, LLC",
      "SubstanceName": "ESCITALOPRAM OXALATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20130920",
      "EndMarketingDatePackage": "20191231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2).",
      "Description": "Escitalopram tablets USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP, is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. C20H21FN2O  C2H2O4  M.W. 414.43. Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP are film-coated, round tablets containing escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide."
    },
    {
      "NDCCode": "0178-0460-04",
      "PackageDescription": "10 TUBE in 1 CARTON (0178-0460-04)  / 4 g in 1 TUBE",
      "NDC11Code": "00178-0460-04",
      "ProductNDC": "0178-0460",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar-e Green",
      "NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110915",
      "SamplePackage": "Y",
      "IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
      "Description": "Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, chromium oxide green, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
    },
    {
      "NDCCode": "0178-0465-04",
      "PackageDescription": "10 TUBE in 1 CARTON (0178-0465-04)  / 4 g in 1 TUBE",
      "NDC11Code": "00178-0465-04",
      "ProductNDC": "0178-0465",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar-e Ls",
      "NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 20",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110915",
      "SamplePackage": "Y",
      "IndicationAndUsage": "This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.",
      "Description": "Each gram contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
    },
    {
      "NDCCode": "0178-0465-05",
      "PackageDescription": "10 PACKET in 1 CARTON (0178-0465-05)  > 5 g in 1 PACKET",
      "NDC11Code": "00178-0465-05",
      "ProductNDC": "0178-0465",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar-e Ls",
      "NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 20",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-21"
    },
    {
      "NDCCode": "0178-0475-04",
      "PackageDescription": "10 TUBE in 1 CARTON (0178-0475-04)  / 4 g in 1 TUBE",
      "NDC11Code": "00178-0475-04",
      "ProductNDC": "0178-0475",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar Ls",
      "NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 20",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110915",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0178-0475-05",
      "PackageDescription": "10 PACKET in 1 CARTON (0178-0475-05)  > 5 g in 1 PACKET",
      "NDC11Code": "00178-0475-05",
      "ProductNDC": "0178-0475",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar Ls",
      "NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 20",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0178-0485-04",
      "PackageDescription": "10 TUBE in 1 CARTON (0178-0485-04)  / 4 mL in 1 TUBE",
      "NDC11Code": "00178-0485-04",
      "ProductNDC": "0178-0485",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ovace Plus",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110915",
      "SamplePackage": "Y",
      "IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).",
      "Description": "Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond triglycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C8H9N2NaO3S·H2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
    },
    {
      "NDCCode": "0178-0485-05",
      "PackageDescription": "10 PACKET in 1 CARTON (0178-0485-05)  > 5 mL in 1 PACKET",
      "NDC11Code": "00178-0485-05",
      "ProductNDC": "0178-0485",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ovace Plus",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-21"
    },
    {
      "NDCCode": "0178-0490-04",
      "PackageDescription": "10 TUBE in 1 CARTON (0178-0490-04)  / 4 mL in 1 TUBE",
      "NDC11Code": "00178-0490-04",
      "ProductNDC": "0178-0490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ovace Plus",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110915",
      "SamplePackage": "Y",
      "IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.",
      "Description": "FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION. Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
    },
    {
      "NDCCode": "0178-0490-05",
      "PackageDescription": "10 PACKET in 1 CARTON (0178-0490-05)  > 5 mL in 1 PACKET",
      "NDC11Code": "00178-0490-05",
      "ProductNDC": "0178-0490",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ovace Plus",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-24"
    },
    {
      "NDCCode": "0178-0495-04",
      "PackageDescription": "10 TUBE in 1 CARTON (0178-0495-04)  / 4 g in 1 TUBE",
      "NDC11Code": "00178-0495-04",
      "ProductNDC": "0178-0495",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ovaceplus",
      "ProprietaryNameSuffix": "Plus",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110915",
      "SamplePackage": "Y",
      "IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.",
      "Description": "Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
    },
    {
      "NDCCode": "0178-0620-04",
      "PackageDescription": "10 TUBE in 1 CARTON (0178-0620-04)  / 4 g in 1 TUBE",
      "NDC11Code": "00178-0620-04",
      "ProductNDC": "0178-0620",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ovace",
      "ProprietaryNameSuffix": "Plus",
      "NonProprietaryName": "Sulfacetamide Sodium",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "98",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110915",
      "SamplePackage": "N",
      "IndicationAndUsage": "This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.",
      "Description": "Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
    },
    {
      "NDCCode": "0178-0640-10",
      "PackageDescription": "10 PACKET in 1 CARTON (0178-0640-10)  > 4 g in 1 PACKET (0178-0640-01) ",
      "NDC11Code": "00178-0640-10",
      "ProductNDC": "0178-0640",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar Ls Cleansing Pads",
      "NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "EndMarketingDate": "20191130",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 20",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-12-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110915",
      "EndMarketingDatePackage": "20191130",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0178-0650-10",
      "PackageDescription": "10 PACKET in 1 CARTON (0178-0650-10)  > 4 g in 1 PACKET (0178-0650-01) ",
      "NDC11Code": "00178-0650-10",
      "ProductNDC": "0178-0650",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar Cleansing Pads",
      "NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110915",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "95; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0178-0653-10",
      "PackageDescription": "6 CANISTER in 1 CARTON (0178-0653-10)  > 10 g in 1 CANISTER",
      "NDC11Code": "00178-0653-10",
      "ProductNDC": "0178-0653",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar Ls",
      "NonProprietaryName": "Sodium Sulfacetamide, Sulfur",
      "DosageFormName": "AEROSOL, FOAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100715",
      "EndMarketingDate": "20190930",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM; SULFUR",
      "StrengthNumber": "100; 20",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100715",
      "EndMarketingDatePackage": "20190930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0178-0658-10",
      "PackageDescription": "6 CANISTER in 1 CARTON (0178-0658-10)  > 10 g in 1 CANISTER",
      "NDC11Code": "00178-0658-10",
      "ProductNDC": "0178-0658",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Avar",
      "NonProprietaryName": "Sodium Sulfacetamide, Sulfur",
      "DosageFormName": "AEROSOL, FOAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100715",
      "EndMarketingDate": "20190531",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFUR; SULFACETAMIDE SODIUM",
      "StrengthNumber": "50; 95",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC],Sulfonamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100715",
      "EndMarketingDatePackage": "20190531",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0178-0696-10",
      "PackageDescription": "6 CANISTER in 1 CARTON (0178-0696-10)  > 10 g in 1 CANISTER",
      "NDC11Code": "00178-0696-10",
      "ProductNDC": "0178-0696",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ovace",
      "ProprietaryNameSuffix": "Plus",
      "NonProprietaryName": "Sodium Sulfacetamide",
      "DosageFormName": "AEROSOL, FOAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100715",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "SubstanceName": "SULFACETAMIDE SODIUM",
      "StrengthNumber": "98",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20100715",
      "SamplePackage": "Y",
      "Description": "Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol, and xanthan gum. This product also contains tetrafluoroethane (propellant). Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether."
    },
    {
      "NDCCode": "0178-0832-30",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (0178-0832-30)  / 1 KIT in 1 BLISTER PACK *  5 TABLET, FILM COATED in 1 BLISTER PACK *  10 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00178-0832-30",
      "ProductNDC": "0178-0832",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Citranatal B-calm",
      "NonProprietaryName": "Ascorbic Acid, Calcium Citrate, Iron, Cholecalciferol, Pyridoxine Hydrochloride, And Folic Acid",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20120618",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Mission Pharmacal Company",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20120618",
      "SamplePackage": "N",
      "IndicationAndUsage": "CitraNatal B-Calm ®is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. CitraNatal B-Calm ®may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.",
      "Description": "CitraNatal B-Calm ®is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6tablets. The prenatal tablet contains Ferr-Ease ®, a patented dualiron delivery comprising both a quick release and slow release iron. The prenatal tablet is white, coated, modified oval, and is debossed with \"0832\" on one side and is blank on the other. The B 625 mg tablets are white to off-white, uncoated, round, and are debossed with \"B\" on one side and \"6\" on the other."
    },
    {
      "NDCCode": "10056-178-10",
      "PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (10056-178-10)",
      "NDC11Code": "10056-0178-10",
      "ProductNDC": "10056-178",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Body Series Deodorant And Antiperspirant Roll-on",
      "ProprietaryNameSuffix": "Regular Scent",
      "NonProprietaryName": "Aluminum Chlorohydrate",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110411",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Access Business Group, Inc.",
      "SubstanceName": "ALUMINUM CHLOROHYDRATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-28",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "31722-178-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (31722-178-10) ",
      "NDC11Code": "31722-0178-10",
      "ProductNDC": "31722-178",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril",
      "NonProprietaryName": "Lisinopril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210817",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075903",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "LISINOPRIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2021-11-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210817",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisinopril tablets are an angiotensin converting enzyme (ACE) inhibitor indicated for:   Treatment of hypertension in adults and pediatric patients 6 years of age and older  (1.1)  Adjunct therapy for heart failure  (1.2)  Treatment of Acute Myocardial Infarction  (1.3).",
      "Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor.  Lisinopril, a synthetic peptide derivative, is chemically described as 1-[N2-[( S)-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate.  Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white crystalline powder, with a molecular weight of 441.52.  It is soluble in water, sparingly soluble in methanol, practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, mannitol and pregelatinized starch (maize). In addition 5 mg, 10 mg, 20 mg and 30 mg tablets contain ferric oxide red, and 40 mg tablets contain ferric oxide yellow."
    }
  ]
}
                    

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    <PackageDescription>5 BLISTER PACK in 1 CARTON (0178-0891-10)  &gt; 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00178-0891-10</NDC11Code>
    <ProductNDC>0178-0891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citranatal Assure</ProprietaryName>
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    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20140430</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2022-10-29</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <NDCCode>0178-0891-30</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (0178-0891-30)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00178-0891-30</NDC11Code>
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    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citranatal Assure</ProprietaryName>
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    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
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    <NDCCode>0121-0891-20</NDCCode>
    <PackageDescription>2 TRAY in 1 CASE (0121-0891-20)  &gt; 10 CUP, UNIT-DOSE in 1 TRAY &gt; 5 mL in 1 CUP, UNIT-DOSE (0121-0891-05) </PackageDescription>
    <NDC11Code>00121-0891-20</NDC11Code>
    <ProductNDC>0121-0891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felbamate</ProprietaryName>
    <NonProprietaryName>Felbamate</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206314</ApplicationNumber>
    <LabelerName>Pharmaceutical Associates, Inc.</LabelerName>
    <SubstanceName>FELBAMATE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>23155-891-10</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (23155-891-10) </PackageDescription>
    <NDC11Code>23155-0891-10</NDC11Code>
    <ProductNDC>23155-891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231019</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208058</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lurasidone hydrochloride tablet is indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]., 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]., 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-­ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C28H36N4O2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, mannitol, polyethylene glycol, pregelatinized starch and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>33261-891-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (33261-891-10)</PackageDescription>
    <NDC11Code>33261-0891-10</NDC11Code>
    <ProductNDC>33261-891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levofloxacin</ProprietaryName>
    <NonProprietaryName>Levofloxacin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090367</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LEVOFLOXACIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) , 2 Acute bacterial sinusitis (1.4) , 3 Acute bacterial exacerbation of chronic bronchitis (1.5) , 4 Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) , 5 Chronic bacterial prostatitis (1.8) , 6 Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) , 7 Acute pyelonephritis (1.11) , 8 Inhalational anthrax, post-exposure (1.13), 9 Plague (1.14).</IndicationAndUsage>
    <Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4½ H2O and the molecular weight is 370.38. Levofloxacin is a white to light yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:. Al+3&gt;Cu+2&gt;Zn+2&gt;Mg+2&gt;Ca+2. Excipients and Description of Dosage Forms. Levofloxacin Tablets. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: : 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide,  hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol,  polysorbate 80, povidone, propylene glycol, sodium starch glycolate and titanium dioxide., 2 500 mg (as expressed in the anhydrous form):  colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol,  sodium starch glycolate and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, hypromellose,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol, sodium starch glycolate and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>37000-891-10</NDCCode>
    <PackageDescription>2 CARTON in 1 CELLO PACK (37000-891-10)  / 1 TUBE in 1 CARTON / 144 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0891-10</NDC11Code>
    <ProductNDC>37000-891</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Pro-health Advanced</ProprietaryName>
    <NonProprietaryName>Stannous Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20161229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>STANNOUS FLUORIDE</SubstanceName>
    <StrengthNumber>1.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>43598-891-10</NDCCode>
    <PackageDescription>100 CUP, UNIT-DOSE in 1 PACKAGE (43598-891-10)  &gt; 15 mL in 1 CUP, UNIT-DOSE (43598-891-16) </PackageDescription>
    <NDC11Code>43598-0891-10</NDC11Code>
    <ProductNDC>43598-891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213062</ApplicationNumber>
    <LabelerName>Dr. Reddy�s Laboratories, Inc.</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>meq/15mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride Oral Solution, USP is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
    <Description>Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution: 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&amp;C Yellow #6, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&amp;C Yellow #6, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>43744-891-10</NDCCode>
    <PackageDescription>1 g in 1 DRUM (43744-891-10)</PackageDescription>
    <NDC11Code>43744-0891-10</NDC11Code>
    <ProductNDC>43744-891</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20120103</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>49288-0891-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0891-3)</PackageDescription>
    <NDC11Code>49288-0891-03</NDC11Code>
    <ProductNDC>49288-0891</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Treatment Set Ts348335</ProprietaryName>
    <NonProprietaryName>Treatment Set Ts348335</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19861031</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>PERIPLANETA AMERICANA; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS</SubstanceName>
    <StrengthNumber>.002; .002; .01; .01; .01; .01</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>When the natural exposure to elevated aeroallergens produces symptoms as described under Clinical Pharmacology, specific diagnosis and therapeutic procedures are indicated. Clearly, important clues to the cause of a person's allergic condition can be gleaned from a thorough history and careful physical examination. Diagnostic tests - in vitro or in vivo - serve only to confirm the physician's suspicions or to improve investigative skills. Specific diagnosis is especially indicated when the patient's symptoms are not controlled by medication. When immunotherapy is contemplated demonstration of sensitivity to a specific allergenic extract is necessary. An orderly approach to the use of diagnostic tests usually begins with direct skin testing. 5,6,11. THIS PRODUCT IS NOT INTENDED FOR TREATMENT OF PATIENTS WHO DO NOT MANIFEST IMMEDIATE HYPERSENSITIVITY REACTIONS TO THE ALLERGENIC EXTRACT FOLLOWING SKIN TESTING.</IndicationAndUsage>
    <Description>Allergenic extract in this vial is referred to as an individual treatment vial since it is designed primarily for the physician equipped to complete skin testing and supervise allergenic extract immunotherapy. The extract is sterile and intended for subcutaneous injection. The concentration of allergenic extract supplied will be based on the individual physician's prescription order and will be expressed in most cases on a weight/volume basis (or AU/ml with standardized extract) diluted either 1:10 or 1:5. Where mixtures of pollens and non-pollens have been ordered, the ingredients are listed on the final container label. To insure maximum potency for the entire dating period, dilutions will be prepared with 50% v/v glycerine unless otherwise specified. Ingredients - Active allergens, preservative and stabilizer are noted on the Physicians Prescription Ingredients Insert enclosed with each individual allergenic extract treatment vial. Dating Period - A twelve month dating period (expiration date) for the prescription vial will be on the container label. Extract Treatment Sets should be reordered when outdated. Government requirements include a two week holding period for sterility tests. Please allow three weeks minimum for delivery.</Description>
  </NDC>
  <NDC>
    <NDCCode>49349-891-10</NDCCode>
    <PackageDescription>6 TABLET in 1 BOTTLE (49349-891-10)</PackageDescription>
    <NDC11Code>49349-0891-10</NDC11Code>
    <ProductNDC>49349-891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078218</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>54458-891-10</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (54458-891-10) </PackageDescription>
    <NDC11Code>54458-0891-10</NDC11Code>
    <ProductNDC>54458-891</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram</ProprietaryName>
    <NonProprietaryName>Escitalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130920</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076765</ApplicationNumber>
    <LabelerName>International Laboratories, LLC</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130920</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2).</IndicationAndUsage>
    <Description>Escitalopram tablets USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP, is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. C20H21FN2O  C2H2O4  M.W. 414.43. Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP are film-coated, round tablets containing escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0460-04</NDCCode>
    <PackageDescription>10 TUBE in 1 CARTON (0178-0460-04)  / 4 g in 1 TUBE</PackageDescription>
    <NDC11Code>00178-0460-04</NDC11Code>
    <ProductNDC>0178-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar-e Green</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
    <Description>Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, chromium oxide green, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0465-04</NDCCode>
    <PackageDescription>10 TUBE in 1 CARTON (0178-0465-04)  / 4 g in 1 TUBE</PackageDescription>
    <NDC11Code>00178-0465-04</NDC11Code>
    <ProductNDC>0178-0465</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar-e Ls</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 20</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.</IndicationAndUsage>
    <Description>Each gram contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0465-05</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (0178-0465-05)  &gt; 5 g in 1 PACKET</PackageDescription>
    <NDC11Code>00178-0465-05</NDC11Code>
    <ProductNDC>0178-0465</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar-e Ls</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 20</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0178-0475-04</NDCCode>
    <PackageDescription>10 TUBE in 1 CARTON (0178-0475-04)  / 4 g in 1 TUBE</PackageDescription>
    <NDC11Code>00178-0475-04</NDC11Code>
    <ProductNDC>0178-0475</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar Ls</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 20</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0178-0475-05</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (0178-0475-05)  &gt; 5 g in 1 PACKET</PackageDescription>
    <NDC11Code>00178-0475-05</NDC11Code>
    <ProductNDC>0178-0475</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar Ls</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 20</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0178-0485-04</NDCCode>
    <PackageDescription>10 TUBE in 1 CARTON (0178-0485-04)  / 4 mL in 1 TUBE</PackageDescription>
    <NDC11Code>00178-0485-04</NDC11Code>
    <ProductNDC>0178-0485</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ovace Plus</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).</IndicationAndUsage>
    <Description>Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond triglycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C8H9N2NaO3S·H2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0485-05</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (0178-0485-05)  &gt; 5 mL in 1 PACKET</PackageDescription>
    <NDC11Code>00178-0485-05</NDC11Code>
    <ProductNDC>0178-0485</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ovace Plus</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0178-0490-04</NDCCode>
    <PackageDescription>10 TUBE in 1 CARTON (0178-0490-04)  / 4 mL in 1 TUBE</PackageDescription>
    <NDC11Code>00178-0490-04</NDC11Code>
    <ProductNDC>0178-0490</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ovace Plus</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.</IndicationAndUsage>
    <Description>FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION. Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0490-05</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (0178-0490-05)  &gt; 5 mL in 1 PACKET</PackageDescription>
    <NDC11Code>00178-0490-05</NDC11Code>
    <ProductNDC>0178-0490</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ovace Plus</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-02-24</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0178-0495-04</NDCCode>
    <PackageDescription>10 TUBE in 1 CARTON (0178-0495-04)  / 4 g in 1 TUBE</PackageDescription>
    <NDC11Code>00178-0495-04</NDC11Code>
    <ProductNDC>0178-0495</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ovaceplus</ProprietaryName>
    <ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.</IndicationAndUsage>
    <Description>Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0620-04</NDCCode>
    <PackageDescription>10 TUBE in 1 CARTON (0178-0620-04)  / 4 g in 1 TUBE</PackageDescription>
    <NDC11Code>00178-0620-04</NDC11Code>
    <ProductNDC>0178-0620</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ovace</ProprietaryName>
    <ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>98</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.</IndicationAndUsage>
    <Description>Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0640-10</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (0178-0640-10)  &gt; 4 g in 1 PACKET (0178-0640-01) </PackageDescription>
    <NDC11Code>00178-0640-10</NDC11Code>
    <ProductNDC>0178-0640</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar Ls Cleansing Pads</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <EndMarketingDate>20191130</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 20</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110915</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0178-0650-10</NDCCode>
    <PackageDescription>10 PACKET in 1 CARTON (0178-0650-10)  &gt; 4 g in 1 PACKET (0178-0650-01) </PackageDescription>
    <NDC11Code>00178-0650-10</NDC11Code>
    <ProductNDC>0178-0650</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar Cleansing Pads</ProprietaryName>
    <NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110915</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>95; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0178-0653-10</NDCCode>
    <PackageDescription>6 CANISTER in 1 CARTON (0178-0653-10)  &gt; 10 g in 1 CANISTER</PackageDescription>
    <NDC11Code>00178-0653-10</NDC11Code>
    <ProductNDC>0178-0653</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar Ls</ProprietaryName>
    <NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100715</StartMarketingDate>
    <EndMarketingDate>20190930</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM; SULFUR</SubstanceName>
    <StrengthNumber>100; 20</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100715</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0178-0658-10</NDCCode>
    <PackageDescription>6 CANISTER in 1 CARTON (0178-0658-10)  &gt; 10 g in 1 CANISTER</PackageDescription>
    <NDC11Code>00178-0658-10</NDC11Code>
    <ProductNDC>0178-0658</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Avar</ProprietaryName>
    <NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100715</StartMarketingDate>
    <EndMarketingDate>20190531</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFUR; SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>50; 95</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC],Sulfonamides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100715</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0178-0696-10</NDCCode>
    <PackageDescription>6 CANISTER in 1 CARTON (0178-0696-10)  &gt; 10 g in 1 CANISTER</PackageDescription>
    <NDC11Code>00178-0696-10</NDC11Code>
    <ProductNDC>0178-0696</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ovace</ProprietaryName>
    <ProprietaryNameSuffix>Plus</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Sulfacetamide</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100715</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
    <StrengthNumber>98</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100715</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <Description>Each gram contains 98 mg of sodium sulfacetamide in a vehicle consisting of: benzyl alcohol, cetyl alcohol, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, phenoxyethanol, propylene glycol, purified water, sodium lauryl sulfate, sodium magnesium silicate, sodium thiosulfate, stearyl alcohol, and xanthan gum. This product also contains tetrafluoroethane (propellant). Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8H 9N 2NaO 3S·H 2O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:. Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>0178-0832-30</NDCCode>
    <PackageDescription>6 BLISTER PACK in 1 CARTON (0178-0832-30)  / 1 KIT in 1 BLISTER PACK *  5 TABLET, FILM COATED in 1 BLISTER PACK *  10 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00178-0832-30</NDC11Code>
    <ProductNDC>0178-0832</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citranatal B-calm</ProprietaryName>
    <NonProprietaryName>Ascorbic Acid, Calcium Citrate, Iron, Cholecalciferol, Pyridoxine Hydrochloride, And Folic Acid</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20120618</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Mission Pharmacal Company</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2025-05-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CitraNatal B-Calm ®is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. CitraNatal B-Calm ®may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.</IndicationAndUsage>
    <Description>CitraNatal B-Calm ®is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6tablets. The prenatal tablet contains Ferr-Ease ®, a patented dualiron delivery comprising both a quick release and slow release iron. The prenatal tablet is white, coated, modified oval, and is debossed with "0832" on one side and is blank on the other. The B 625 mg tablets are white to off-white, uncoated, round, and are debossed with "B" on one side and "6" on the other.</Description>
  </NDC>
  <NDC>
    <NDCCode>10056-178-10</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE, PLASTIC (10056-178-10)</PackageDescription>
    <NDC11Code>10056-0178-10</NDC11Code>
    <ProductNDC>10056-178</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Body Series Deodorant And Antiperspirant Roll-on</ProprietaryName>
    <ProprietaryNameSuffix>Regular Scent</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110411</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Access Business Group, Inc.</LabelerName>
    <SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-28</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>31722-178-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (31722-178-10) </PackageDescription>
    <NDC11Code>31722-0178-10</NDC11Code>
    <ProductNDC>31722-178</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisinopril</ProprietaryName>
    <NonProprietaryName>Lisinopril</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075903</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LISINOPRIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisinopril tablets are an angiotensin converting enzyme (ACE) inhibitor indicated for:   Treatment of hypertension in adults and pediatric patients 6 years of age and older  (1.1)  Adjunct therapy for heart failure  (1.2)  Treatment of Acute Myocardial Infarction  (1.3).</IndicationAndUsage>
    <Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor.  Lisinopril, a synthetic peptide derivative, is chemically described as 1-[N2-[( S)-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate.  Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white crystalline powder, with a molecular weight of 441.52.  It is soluble in water, sparingly soluble in methanol, practically insoluble in alcohol, in acetone, in acetonitrile and in chloroform. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, mannitol and pregelatinized starch (maize). In addition 5 mg, 10 mg, 20 mg and 30 mg tablets contain ferric oxide red, and 40 mg tablets contain ferric oxide yellow.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>0178-0891-10</NDCCode><ProprietaryName>Citranatal Assure</ProprietaryName><NonProprietaryName>Ascorbic Acid, Calcium Citrate, Iron, Vitamin D, Dl- Alpha- Tocopherol Acetate, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Doconexent And Icosapent</NonProprietaryName></NDC><NDC><NDCCode>0178-0891-30</NDCCode><ProprietaryName>Citranatal Assure</ProprietaryName><NonProprietaryName>Ascorbic Acid, Calcium Citrate, Iron, Vitamin D, Dl- Alpha- Tocopherol Acetate, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Doconexent And Icosapent</NonProprietaryName></NDC><NDC><NDCCode>0121-0891-20</NDCCode><ProprietaryName>Felbamate</ProprietaryName><NonProprietaryName>Felbamate</NonProprietaryName></NDC><NDC><NDCCode>23155-891-10</NDCCode><ProprietaryName>Lurasidone Hydrochloride</ProprietaryName><NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33261-891-10</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>37000-891-10</NDCCode><ProprietaryName>Crest Pro-health Advanced</ProprietaryName><NonProprietaryName>Stannous Fluoride</NonProprietaryName></NDC><NDC><NDCCode>43598-891-10</NDCCode><ProprietaryName>Potassium Chloride</ProprietaryName><NonProprietaryName>Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>43744-891-10</NDCCode><NonProprietaryName>Tadalafil</NonProprietaryName></NDC><NDC><NDCCode>49288-0891-3</NDCCode><ProprietaryName>Treatment Set Ts348335</ProprietaryName><NonProprietaryName>Treatment Set Ts348335</NonProprietaryName></NDC><NDC><NDCCode>49349-891-10</NDCCode><ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54458-891-10</NDCCode><ProprietaryName>Escitalopram</ProprietaryName><NonProprietaryName>Escitalopram</NonProprietaryName></NDC><NDC><NDCCode>0178-0460-04</NDCCode><ProprietaryName>Avar-e Green</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0465-04</NDCCode><ProprietaryName>Avar-e Ls</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0465-05</NDCCode><ProprietaryName>Avar-e Ls</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0475-04</NDCCode><ProprietaryName>Avar Ls</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0475-05</NDCCode><ProprietaryName>Avar Ls</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0485-04</NDCCode><ProprietaryName>Ovace Plus</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC><NDC><NDCCode>0178-0485-05</NDCCode><ProprietaryName>Ovace Plus</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC><NDC><NDCCode>0178-0490-04</NDCCode><ProprietaryName>Ovace Plus</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC><NDC><NDCCode>0178-0490-05</NDCCode><ProprietaryName>Ovace Plus</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC><NDC><NDCCode>0178-0495-04</NDCCode><ProprietaryName>Ovaceplus</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC><NDC><NDCCode>0178-0620-04</NDCCode><ProprietaryName>Ovace</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName></NDC><NDC><NDCCode>0178-0640-10</NDCCode><ProprietaryName>Avar Ls Cleansing Pads</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0650-10</NDCCode><ProprietaryName>Avar Cleansing Pads</ProprietaryName><NonProprietaryName>Sulfacetamide Sodium, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0653-10</NDCCode><ProprietaryName>Avar Ls</ProprietaryName><NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0658-10</NDCCode><ProprietaryName>Avar</ProprietaryName><NonProprietaryName>Sodium Sulfacetamide, Sulfur</NonProprietaryName></NDC><NDC><NDCCode>0178-0696-10</NDCCode><ProprietaryName>Ovace</ProprietaryName><NonProprietaryName>Sodium Sulfacetamide</NonProprietaryName></NDC><NDC><NDCCode>0178-0832-30</NDCCode><ProprietaryName>Citranatal B-calm</ProprietaryName><NonProprietaryName>Ascorbic Acid, Calcium Citrate, Iron, Cholecalciferol, Pyridoxine Hydrochloride, And Folic Acid</NonProprietaryName></NDC><NDC><NDCCode>10056-178-10</NDCCode><ProprietaryName>Body Series Deodorant And Antiperspirant Roll-on</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>31722-178-10</NDCCode><ProprietaryName>Lisinopril</ProprietaryName><NonProprietaryName>Lisinopril</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

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

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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