RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (37 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "57955-6001-2",
      "PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-6001-2)",
      "NDC11Code": "57955-6001-02",
      "ProductNDC": "57955-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Indoor Air Pollution Detox",
      "NonProprietaryName": "Acetaldehyde, Ammonium Causticum, Carboneum Oxygenisatum, Chloroformum, Formalinum, Glycyrrhiza Glabra, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Petroleum, Plumbum Metallicum, Taraxacum Officinale",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140528",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "King Bio Inc.",
      "SubstanceName": "ACETALDEHYDE; AMMONIA; CARBON MONOXIDE; CHLOROFORM; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; KEROSENE; LEAD; TARAXACUM OFFICINALE",
      "StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
      "StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses temporarily relieves symptoms due to indoor air pollutants: breathing difficulties, eye, throat and lung irritation, fatigue, nausea, headaches."
    },
    {
      "NDCCode": "0069-6001-25",
      "PackageDescription": "25 VIAL in 1 CARTON (0069-6001-25)  / 2 mL in 1 VIAL (0069-6001-02) ",
      "NDC11Code": "00069-6001-25",
      "ProductNDC": "0069-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cerebyx",
      "NonProprietaryName": "Fosphenytoin Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20131028",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020450",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "FOSPHENYTOIN SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20131028",
      "SamplePackage": "N",
      "IndicationAndUsage": "CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
      "Description": "CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24."
    },
    {
      "NDCCode": "10819-6001-2",
      "PackageDescription": "529.46 mL in 1 CANISTER (10819-6001-2) ",
      "NDC11Code": "10819-6001-02",
      "ProductNDC": "10819-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sani Professional Brand Sani-hands",
      "ProprietaryNameSuffix": "Instant Hand Sanitizing Wipes",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "CLOTH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20080101",
      "EndMarketingDate": "20221231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Professional Disposables International Inc",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".659",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20080101",
      "EndMarketingDatePackage": "20221231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "34605-6001-2",
      "PackageDescription": "20 PACKET in 1 CARTON (34605-6001-2)  > 2 g in 1 PACKET (34605-6001-1)",
      "NDC11Code": "34605-6001-02",
      "ProductNDC": "34605-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nosmotea",
      "ProprietaryNameSuffix": "Smoking Deterrent",
      "NonProprietaryName": "Clove Tea",
      "DosageFormName": "POWDER",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100306",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Nosmo Co., Ltd",
      "SubstanceName": "CLOVE; LEMON; MENTHOL",
      "StrengthNumber": "20; 1; 1.5",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "34690-6001-2",
      "PackageDescription": "4 g in 1 BOX (34690-6001-2)",
      "NDC11Code": "34690-6001-02",
      "ProductNDC": "34690-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lavender Sap Patch",
      "NonProprietaryName": "Topical Starch",
      "DosageFormName": "POULTICE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "KJI Industrial Co Ltd",
      "SubstanceName": "STARCH, CORN",
      "StrengthNumber": "2.92",
      "StrengthUnit": "g/4g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "41525-6001-2",
      "PackageDescription": "600 mL in 1 BOTTLE (41525-6001-2)",
      "NDC11Code": "41525-6001-02",
      "ProductNDC": "41525-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dental Pro",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20140911",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "PBS Co., Ltd.",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".02",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) andput into mouth.② Goggle it thoroughly all over the inner mouth about 10 seconds.③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out."
    },
    {
      "NDCCode": "44738-6001-2",
      "PackageDescription": "10 POUCH in 1 CARTON (44738-6001-2)  > 2000 mg in 1 POUCH (44738-6001-1)",
      "NDC11Code": "44738-6001-02",
      "ProductNDC": "44738-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ginsamin Beauty",
      "NonProprietaryName": "Ginkgo Leaf Extract",
      "DosageFormName": "GRANULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100307",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Biogrand Co., Ltd",
      "SubstanceName": "GINKGO; ASIAN GINSENG; N-ACETYLGLUCOSAMINE; HYALURONIC ACID",
      "StrengthNumber": "150; 150; 200; 60",
      "StrengthUnit": "mg/2000mg; mg/2000mg; mg/2000mg; mg/2000mg",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "47649-6001-2",
      "PackageDescription": "3 TUBE in 1 BOX (47649-6001-2)  > 5 g in 1 TUBE (47649-6001-1)",
      "NDC11Code": "47649-6001-02",
      "ProductNDC": "47649-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "O Blanctis",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20120207",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Nibec Co., Ltd",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "50",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "48951-6001-2",
      "PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-6001-2) ",
      "NDC11Code": "48951-6001-02",
      "ProductNDC": "48951-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Juglans Stannum Special Order",
      "NonProprietaryName": "Juglans Stannum Special Order",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc.",
      "SubstanceName": "JUGLANS REGIA LEAF; POTASSIUM PHOSPHATE, MONOBASIC; TIN",
      "StrengthNumber": "12; 6; 12",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20090901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
    },
    {
      "NDCCode": "51754-6001-4",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6001-4)  / 2 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "51754-6001-04",
      "ProductNDC": "51754-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glyrx-pf",
      "NonProprietaryName": "Glycopyrrolate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20180801",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210997",
      "LabelerName": "Exela Pharma Sciences, LLC",
      "SubstanceName": "GLYCOPYRROLATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-07-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180801",
      "SamplePackage": "N",
      "IndicationAndUsage": "GLYRX®-PF is indicated. in anesthesia (all ages): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation,, 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and, 3 for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents.",
      "Description": "GLYRX®-PF is a synthetic anticholinergic agent. It is intended for intramuscular or intravenous administration. Each 1 mL of GLYRX®-PF contains 0.2 mg of glycopyrrolate, water for injection, sodium chloride as a tonicity agent, and hydrochloric acid or sodium hydroxide as pH adjusters. GLYRX®-PF is preservative free. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. The molecular formula is C19H28BrNO3 and the molecular weight is 398.34. Glycopyrrolate structural formula is as follows. Glycopyrrolate occurs as a white, odorless, crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It is completely ionized at physiological pH values. GLYRX®-PF is a clear, colorless, sterile liquid with a pH of 2.0 – 3.0. The partition coefficient of Glycopyrrolate in n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C)."
    },
    {
      "NDCCode": "52652-6001-2",
      "PackageDescription": "1 BOTTLE in 1 CARTON (52652-6001-2)  / 300 mL in 1 BOTTLE",
      "NDC11Code": "52652-6001-02",
      "ProductNDC": "52652-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fleqsuvy",
      "NonProprietaryName": "Baclofen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220207",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA215602",
      "LabelerName": "Azurity Pharmaceuticals, Inc.",
      "SubstanceName": "BACLOFEN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220207",
      "SamplePackage": "N",
      "IndicationAndUsage": "FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.",
      "Description": "FLEQSUVY (baclofen oral suspension) is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Molecular formula is C 10H 12C1NO 2. Molecular Weight is 213.66 g/mol. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The FLEQSUVY (baclofen oral suspension) inactive ingredients are: artificial grape flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, hydroxyethyl cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, and sucralose."
    },
    {
      "NDCCode": "62795-6001-4",
      "PackageDescription": "1 KIT in 1 KIT (62795-6001-4)  *  100 TABLET in 1 BOTTLE (62795-1029-2)  *  50 g in 1 TUBE (62795-7002-7)",
      "NDC11Code": "62795-6001-04",
      "ProductNDC": "62795-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "T-relief Value Pack",
      "NonProprietaryName": "T-relief",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20140830",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "MediNatura",
      "Status": "Deprecated",
      "LastUpdate": "2018-04-05",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "63804-6001-2",
      "PackageDescription": "3785 mL in 1 JUG (63804-6001-2) ",
      "NDC11Code": "63804-6001-02",
      "ProductNDC": "63804-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Pisgah labs, inc",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "80",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-06-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69640-6001-2",
      "PackageDescription": "2 CONTAINER in 1 CARTON (69640-6001-2)  > 15 g in 1 CONTAINER (69640-6001-1)",
      "NDC11Code": "69640-6001-02",
      "ProductNDC": "69640-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Donginbi Red Ginseng Radiance",
      "ProprietaryNameSuffix": "Cushion Bb 23",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, Octisalate",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150308",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "KGC LIFE&GIN",
      "SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "1.05; .75; 1.88",
      "StrengthUnit": "g/15g; g/15g; g/15g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "Description": "Uses: Press the sponge with built-in puff, take out proper quantity, then apply it along the skin texture, thin and wide, finish with massage. Directions: following the use of base, take a suitable amount on the back of your hand and spread it over your face thinly flowing skin texture."
    },
    {
      "NDCCode": "76344-6001-2",
      "PackageDescription": "1 TUBE in 1 BOX (76344-6001-2)  > 50 mL in 1 TUBE (76344-6001-1)",
      "NDC11Code": "76344-6001-02",
      "ProductNDC": "76344-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Derma Blemish Balm",
      "NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130422",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Humex,Inc.",
      "SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "6.5; 4.24; 3.5",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2015-01-23"
    },
    {
      "NDCCode": "76369-6001-2",
      "PackageDescription": "300 mL in 1 BOX (76369-6001-2)",
      "NDC11Code": "76369-6001-02",
      "ProductNDC": "76369-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Msm (mosaengmo)",
      "NonProprietaryName": "Propylene Glycol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111111",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Handock Cosmetics Inc",
      "SubstanceName": "PROPYLENE GLYCOL",
      "StrengthNumber": "23.85",
      "StrengthUnit": "mL/150mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "77419-6001-2",
      "PackageDescription": "473 mL in 1 BOTTLE, PUMP (77419-6001-2) ",
      "NDC11Code": "77419-6001-02",
      "ProductNDC": "77419-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Amass Lavender And Fir Hand Sanitizer",
      "NonProprietaryName": "Lavender And Fir Hand Sanitizer",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20201113",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "AMASS Brands, Inc",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "41.3",
      "StrengthUnit": "mL/59mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20201113",
      "SamplePackage": "N",
      "IndicationAndUsage": "USE Hand sanitizer to help reduce disease-causing bacteria."
    },
    {
      "NDCCode": "0069-6001-21",
      "PackageDescription": "10 VIAL in 1 PACKAGE (0069-6001-21)  / 10 mL in 1 VIAL (0069-6001-10) ",
      "NDC11Code": "00069-6001-21",
      "ProductNDC": "0069-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cerebyx",
      "NonProprietaryName": "Fosphenytoin Sodium",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20131028",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020450",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "FOSPHENYTOIN SODIUM",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-08-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20131028",
      "SamplePackage": "N",
      "IndicationAndUsage": "CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].",
      "Description": "CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24."
    },
    {
      "NDCCode": "0245-6001-11",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0245-6001-11)  / 100 TABLET in 1 BOTTLE",
      "NDC11Code": "00245-6001-11",
      "ProductNDC": "0245-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vigadrone",
      "NonProprietaryName": "Vigabatrin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230629",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214749",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "VIGABATRIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230630",
      "SamplePackage": "N",
      "IndicationAndUsage": "VIGADRONE is indicated for the treatment of: 1 Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; VIGADRONE is not indicated as a first line agent ( 1.1) , 2 Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2) .",
      "Description": "VIGADRONE (vigabatrin, USP) is an oral antiepileptic drug and is available as a white, film- coated 500 mg tablet. The chemical name of vigabatrin, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6H 11NO 2and the molecular weight is 129.16. It has the following structural formula:. Vigabatrin, USP is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pK a) of vigabatrin are 4 and 9.7 at room temperature (25°C). Each VIGADRONE tablet contains 500 mg of vigabatrin. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate (potato) and isopropyl alcohol. The tablet coating ingredients are hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide. Approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "0310-6001-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0310-6001-30) ",
      "NDC11Code": "00310-6001-30",
      "ProductNDC": "0310-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Baxfendy",
      "NonProprietaryName": "Baxdrostat",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260515",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA219878",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BAXDROSTAT",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260515",
      "SamplePackage": "N",
      "IndicationAndUsage": "BAXFENDY, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction of these events with BAXFENDY. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the American College of Cardiology/American Heart Association (ACC/AHA). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.",
      "Description": "Baxdrostat is an aldosterone synthase inhibitor. The chemical name of baxdrostat is N-[(8R)-4-(1-methyl-2-oxo-1,2,3,4-tetrahydro-6-quinolinyl)-5,6,7,8-tetrahydro-8-isoquinolinyl]propanamide. The molecular formula is C22H25N3O2 and the molecular weight is 363.45 g/mol. The structural formula is. BAXFENDY is available as a film-coated tablet for oral administration, containing 1 mg or 2 mg of baxdrostat. The inactive ingredients in BAXFENDY are croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide, in addition to ferric oxide red (1 mg strength tablets) or ferric oxide yellow (2 mg strength tablets)."
    },
    {
      "NDCCode": "0310-6001-95",
      "PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (0310-6001-95) ",
      "NDC11Code": "00310-6001-95",
      "ProductNDC": "0310-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Baxfendy",
      "NonProprietaryName": "Baxdrostat",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260515",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA219878",
      "LabelerName": "AstraZeneca Pharmaceuticals LP",
      "SubstanceName": "BAXDROSTAT",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260515",
      "SamplePackage": "Y",
      "IndicationAndUsage": "BAXFENDY, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction of these events with BAXFENDY. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the American College of Cardiology/American Heart Association (ACC/AHA). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.",
      "Description": "Baxdrostat is an aldosterone synthase inhibitor. The chemical name of baxdrostat is N-[(8R)-4-(1-methyl-2-oxo-1,2,3,4-tetrahydro-6-quinolinyl)-5,6,7,8-tetrahydro-8-isoquinolinyl]propanamide. The molecular formula is C22H25N3O2 and the molecular weight is 363.45 g/mol. The structural formula is. BAXFENDY is available as a film-coated tablet for oral administration, containing 1 mg or 2 mg of baxdrostat. The inactive ingredients in BAXFENDY are croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide, in addition to ferric oxide red (1 mg strength tablets) or ferric oxide yellow (2 mg strength tablets)."
    },
    {
      "NDCCode": "0378-6001-91",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91) ",
      "NDC11Code": "00378-6001-91",
      "ProductNDC": "0378-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metformin Hydrochloride",
      "NonProprietaryName": "Metformin",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160823",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200690",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "SubstanceName": "METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160823",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Metformin hydrochloride extended-release tablets, USP contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is 1,1-Dimethybiguanide monohydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Its structural formula is. Metformin hydrochloride, USP is a white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1000 mg of metformin hydrochloride. In addition to the active ingredient metformin hydrochloride, each tablet contains the following inactive ingredients: cellulose acetate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate and yellow iron oxide. In addition, the black imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Meets USP Dissolution Test 5."
    },
    {
      "NDCCode": "0641-6001-25",
      "PackageDescription": "25 VIAL in 1 CARTON (0641-6001-25)  / 1 mL in 1 VIAL (0641-6001-01) ",
      "NDC11Code": "00641-6001-25",
      "ProductNDC": "0641-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ativan",
      "NonProprietaryName": "Lorazepam",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19800725",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018140",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "LORAZEPAM",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19800725",
      "SamplePackage": "N",
      "IndicationAndUsage": "ATIVAN Injection is indicated for the treatment of status epilepticus.",
      "Description": "Lorazepam, a benzodiazepine with antianxiety, sedative, and anticonvulsant effects, is intended for the intramuscular or intravenous routes of administration. It has the chemical formula: 7-chloro-5(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1, 4-benzodiazepin-2-one. The molecular weight is 321.16, and the C.A.S. No. is [846-49-1]. The structural formula is. Lorazepam is a nearly white powder almost insoluble in water. Each mL of sterile injection contains either 2.0 or 4.0 mg of lorazepam, 0.18 mL polyethylene glycol 400 in propylene glycol with 2.0% benzyl alcohol as preservative."
    },
    {
      "NDCCode": "34690-6001-1",
      "PackageDescription": "4 g in 1 BOX (34690-6001-1)",
      "NDC11Code": "34690-6001-01",
      "ProductNDC": "34690-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lavender Sap Patch",
      "NonProprietaryName": "Topical Starch",
      "DosageFormName": "POULTICE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "KJI Industrial Co Ltd",
      "SubstanceName": "STARCH, CORN",
      "StrengthNumber": "2.92",
      "StrengthUnit": "g/4g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "34690-6001-3",
      "PackageDescription": "4 g in 1 BOX (34690-6001-3)",
      "NDC11Code": "34690-6001-03",
      "ProductNDC": "34690-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lavender Sap Patch",
      "NonProprietaryName": "Topical Starch",
      "DosageFormName": "POULTICE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "KJI Industrial Co Ltd",
      "SubstanceName": "STARCH, CORN",
      "StrengthNumber": "2.92",
      "StrengthUnit": "g/4g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "34690-6001-4",
      "PackageDescription": "4 g in 1 BOX (34690-6001-4)",
      "NDC11Code": "34690-6001-04",
      "ProductNDC": "34690-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lavender Sap Patch",
      "NonProprietaryName": "Topical Starch",
      "DosageFormName": "POULTICE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20100115",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "KJI Industrial Co Ltd",
      "SubstanceName": "STARCH, CORN",
      "StrengthNumber": "2.92",
      "StrengthUnit": "g/4g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "52345-6001-1",
      "PackageDescription": "13 mL in 1 CONTAINER (52345-6001-1) ",
      "NDC11Code": "52345-6001-01",
      "ProductNDC": "52345-6001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Drop Dream Eye 2",
      "NonProprietaryName": "Polyhexamethylene Biguanide",
      "DosageFormName": "LIQUID",
      "RouteName": "NASAL; OPHTHALMIC",
      "StartMarketingDate": "20240427",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "K&J.C Co., Ltd",
      "SubstanceName": "POLYAMINOPROPYL BIGUANIDE",
      "StrengthNumber": ".001",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240427",
      "SamplePackage": "N",
      "IndicationAndUsage": "always use fresh solution to disinfacts, to not reuse solution."
    },
    {
      "NDCCode": "52652-6001-1",
      "PackageDescription": "1 BOTTLE in 1 CARTON (52652-6001-1)  / 120 mL in 1 BOTTLE",
      "NDC11Code": "52652-6001-01",
      "ProductNDC": "52652-6001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fleqsuvy",
      "NonProprietaryName": "Baclofen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220207",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA215602",
      "LabelerName": "Azurity Pharmaceuticals, Inc.",
      "SubstanceName": "BACLOFEN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220207",
      "SamplePackage": "N",
      "IndicationAndUsage": "FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.",
      "Description": "FLEQSUVY (baclofen oral suspension) is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Molecular formula is C 10H 12C1NO 2. Molecular Weight is 213.66 g/mol. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The FLEQSUVY (baclofen oral suspension) inactive ingredients are: artificial grape flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, hydroxyethyl cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, and sucralose."
    },
    {
      "NDCCode": "57955-0001-2",
      "PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0001-2)",
      "NDC11Code": "57955-0001-02",
      "ProductNDC": "57955-0001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Eating Disorders",
      "NonProprietaryName": "Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140417",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "King Bio Inc",
      "SubstanceName": "ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT",
      "StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
      "StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders."
    },
    {
      "NDCCode": "57955-0002-2",
      "PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0002-2)",
      "NDC11Code": "57955-0002-02",
      "ProductNDC": "57955-0002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Birth Ease",
      "NonProprietaryName": "Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140417",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "King Bio Inc.",
      "SubstanceName": "ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK",
      "StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
      "StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"57955-6001-2","ProprietaryName":"Indoor Air Pollution Detox","NonProprietaryName":"Acetaldehyde, Ammonium Causticum, Carboneum Oxygenisatum, Chloroformum, Formalinum, Glycyrrhiza Glabra, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Petroleum, Plumbum Metallicum, Taraxacum Officinale"},{"NDCCode":"0069-6001-25","ProprietaryName":"Cerebyx","NonProprietaryName":"Fosphenytoin Sodium"},{"NDCCode":"10819-6001-2","ProprietaryName":"Sani Professional Brand Sani-hands","NonProprietaryName":"Alcohol"},{"NDCCode":"34605-6001-2","ProprietaryName":"Nosmotea","NonProprietaryName":"Clove Tea"},{"NDCCode":"34690-6001-2","ProprietaryName":"Lavender Sap Patch","NonProprietaryName":"Topical Starch"},{"NDCCode":"41525-6001-2","ProprietaryName":"Dental Pro","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"44738-6001-2","ProprietaryName":"Ginsamin Beauty","NonProprietaryName":"Ginkgo Leaf Extract"},{"NDCCode":"47649-6001-2","ProprietaryName":"O Blanctis","NonProprietaryName":"Alcohol"},{"NDCCode":"48951-6001-2","ProprietaryName":"Juglans Stannum Special Order","NonProprietaryName":"Juglans Stannum Special Order"},{"NDCCode":"51754-6001-4","ProprietaryName":"Glyrx-pf","NonProprietaryName":"Glycopyrrolate"},{"NDCCode":"52652-6001-2","ProprietaryName":"Fleqsuvy","NonProprietaryName":"Baclofen"},{"NDCCode":"62795-6001-4","ProprietaryName":"T-relief Value Pack","NonProprietaryName":"T-relief"},{"NDCCode":"63804-6001-2","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"69640-6001-2","ProprietaryName":"Donginbi Red Ginseng Radiance","NonProprietaryName":"Octinoxate, Titanium Dioxide, Octisalate"},{"NDCCode":"76344-6001-2","ProprietaryName":"Derma Blemish Balm","NonProprietaryName":"Octinoxate, Titanium Dioxide, Zinc Oxide"},{"NDCCode":"76369-6001-2","ProprietaryName":"Msm (mosaengmo)","NonProprietaryName":"Propylene Glycol"},{"NDCCode":"77419-6001-2","ProprietaryName":"Amass Lavender And Fir Hand Sanitizer","NonProprietaryName":"Lavender And Fir Hand Sanitizer"},{"NDCCode":"0069-6001-21","ProprietaryName":"Cerebyx","NonProprietaryName":"Fosphenytoin Sodium"},{"NDCCode":"0245-6001-11","ProprietaryName":"Vigadrone","NonProprietaryName":"Vigabatrin"},{"NDCCode":"0310-6001-30","ProprietaryName":"Baxfendy","NonProprietaryName":"Baxdrostat"},{"NDCCode":"0310-6001-95","ProprietaryName":"Baxfendy","NonProprietaryName":"Baxdrostat"},{"NDCCode":"0378-6001-91","ProprietaryName":"Metformin Hydrochloride","NonProprietaryName":"Metformin"},{"NDCCode":"0641-6001-25","ProprietaryName":"Ativan","NonProprietaryName":"Lorazepam"},{"NDCCode":"34690-6001-1","ProprietaryName":"Lavender Sap Patch","NonProprietaryName":"Topical Starch"},{"NDCCode":"34690-6001-3","ProprietaryName":"Lavender Sap Patch","NonProprietaryName":"Topical Starch"},{"NDCCode":"34690-6001-4","ProprietaryName":"Lavender Sap Patch","NonProprietaryName":"Topical Starch"},{"NDCCode":"52345-6001-1","ProprietaryName":"Drop Dream Eye 2","NonProprietaryName":"Polyhexamethylene Biguanide"},{"NDCCode":"52652-6001-1","ProprietaryName":"Fleqsuvy","NonProprietaryName":"Baclofen"},{"NDCCode":"57955-0001-2","ProprietaryName":"Eating Disorders","NonProprietaryName":"Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album"},{"NDCCode":"57955-0002-2","ProprietaryName":"Birth Ease","NonProprietaryName":"Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>57955-6001-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-6001-2)</PackageDescription>
    <NDC11Code>57955-6001-02</NDC11Code>
    <ProductNDC>57955-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Indoor Air Pollution Detox</ProprietaryName>
    <NonProprietaryName>Acetaldehyde, Ammonium Causticum, Carboneum Oxygenisatum, Chloroformum, Formalinum, Glycyrrhiza Glabra, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Petroleum, Plumbum Metallicum, Taraxacum Officinale</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140528</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>King Bio Inc.</LabelerName>
    <SubstanceName>ACETALDEHYDE; AMMONIA; CARBON MONOXIDE; CHLOROFORM; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; KEROSENE; LEAD; TARAXACUM OFFICINALE</SubstanceName>
    <StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses temporarily relieves symptoms due to indoor air pollutants: breathing difficulties, eye, throat and lung irritation, fatigue, nausea, headaches.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0069-6001-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (0069-6001-25)  / 2 mL in 1 VIAL (0069-6001-02) </PackageDescription>
    <NDC11Code>00069-6001-25</NDC11Code>
    <ProductNDC>0069-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cerebyx</ProprietaryName>
    <NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131028</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020450</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24.</Description>
  </NDC>
  <NDC>
    <NDCCode>10819-6001-2</NDCCode>
    <PackageDescription>529.46 mL in 1 CANISTER (10819-6001-2) </PackageDescription>
    <NDC11Code>10819-6001-02</NDC11Code>
    <ProductNDC>10819-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sani Professional Brand Sani-hands</ProprietaryName>
    <ProprietaryNameSuffix>Instant Hand Sanitizing Wipes</ProprietaryNameSuffix>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20080101</StartMarketingDate>
    <EndMarketingDate>20221231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Professional Disposables International Inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.659</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20080101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>34605-6001-2</NDCCode>
    <PackageDescription>20 PACKET in 1 CARTON (34605-6001-2)  &gt; 2 g in 1 PACKET (34605-6001-1)</PackageDescription>
    <NDC11Code>34605-6001-02</NDC11Code>
    <ProductNDC>34605-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nosmotea</ProprietaryName>
    <ProprietaryNameSuffix>Smoking Deterrent</ProprietaryNameSuffix>
    <NonProprietaryName>Clove Tea</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100306</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Nosmo Co., Ltd</LabelerName>
    <SubstanceName>CLOVE; LEMON; MENTHOL</SubstanceName>
    <StrengthNumber>20; 1; 1.5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>34690-6001-2</NDCCode>
    <PackageDescription>4 g in 1 BOX (34690-6001-2)</PackageDescription>
    <NDC11Code>34690-6001-02</NDC11Code>
    <ProductNDC>34690-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lavender Sap Patch</ProprietaryName>
    <NonProprietaryName>Topical Starch</NonProprietaryName>
    <DosageFormName>POULTICE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>KJI Industrial Co Ltd</LabelerName>
    <SubstanceName>STARCH, CORN</SubstanceName>
    <StrengthNumber>2.92</StrengthNumber>
    <StrengthUnit>g/4g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>41525-6001-2</NDCCode>
    <PackageDescription>600 mL in 1 BOTTLE (41525-6001-2)</PackageDescription>
    <NDC11Code>41525-6001-02</NDC11Code>
    <ProductNDC>41525-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dental Pro</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>MOUTHWASH</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20140911</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>PBS Co., Ltd.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.02</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) andput into mouth.② Goggle it thoroughly all over the inner mouth about 10 seconds.③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>44738-6001-2</NDCCode>
    <PackageDescription>10 POUCH in 1 CARTON (44738-6001-2)  &gt; 2000 mg in 1 POUCH (44738-6001-1)</PackageDescription>
    <NDC11Code>44738-6001-02</NDC11Code>
    <ProductNDC>44738-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ginsamin Beauty</ProprietaryName>
    <NonProprietaryName>Ginkgo Leaf Extract</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100307</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Biogrand Co., Ltd</LabelerName>
    <SubstanceName>GINKGO; ASIAN GINSENG; N-ACETYLGLUCOSAMINE; HYALURONIC ACID</SubstanceName>
    <StrengthNumber>150; 150; 200; 60</StrengthNumber>
    <StrengthUnit>mg/2000mg; mg/2000mg; mg/2000mg; mg/2000mg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>47649-6001-2</NDCCode>
    <PackageDescription>3 TUBE in 1 BOX (47649-6001-2)  &gt; 5 g in 1 TUBE (47649-6001-1)</PackageDescription>
    <NDC11Code>47649-6001-02</NDC11Code>
    <ProductNDC>47649-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>O Blanctis</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20120207</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Nibec Co., Ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-03</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>48951-6001-2</NDCCode>
    <PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-6001-2) </PackageDescription>
    <NDC11Code>48951-6001-02</NDC11Code>
    <ProductNDC>48951-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Juglans Stannum Special Order</ProprietaryName>
    <NonProprietaryName>Juglans Stannum Special Order</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090901</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Uriel Pharmacy Inc.</LabelerName>
    <SubstanceName>JUGLANS REGIA LEAF; POTASSIUM PHOSPHATE, MONOBASIC; TIN</SubstanceName>
    <StrengthNumber>12; 6; 12</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51754-6001-4</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6001-4)  / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>51754-6001-04</NDC11Code>
    <ProductNDC>51754-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glyrx-pf</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210997</ApplicationNumber>
    <LabelerName>Exela Pharma Sciences, LLC</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GLYRX®-PF is indicated. in anesthesia (all ages): 1 for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation,, 2 intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and, 3 for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents.</IndicationAndUsage>
    <Description>GLYRX®-PF is a synthetic anticholinergic agent. It is intended for intramuscular or intravenous administration. Each 1 mL of GLYRX®-PF contains 0.2 mg of glycopyrrolate, water for injection, sodium chloride as a tonicity agent, and hydrochloric acid or sodium hydroxide as pH adjusters. GLYRX®-PF is preservative free. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: (RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidinium bromide] α-cyclopentylmandelate. The molecular formula is C19H28BrNO3 and the molecular weight is 398.34. Glycopyrrolate structural formula is as follows. Glycopyrrolate occurs as a white, odorless, crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It is completely ionized at physiological pH values. GLYRX®-PF is a clear, colorless, sterile liquid with a pH of 2.0 – 3.0. The partition coefficient of Glycopyrrolate in n-octanol/water system is 0.304 (log10 P = -1.52) at ambient room temperature (24°C).</Description>
  </NDC>
  <NDC>
    <NDCCode>52652-6001-2</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (52652-6001-2)  / 300 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>52652-6001-02</NDC11Code>
    <ProductNDC>52652-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fleqsuvy</ProprietaryName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220207</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215602</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.</IndicationAndUsage>
    <Description>FLEQSUVY (baclofen oral suspension) is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Molecular formula is C 10H 12C1NO 2. Molecular Weight is 213.66 g/mol. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The FLEQSUVY (baclofen oral suspension) inactive ingredients are: artificial grape flavor, citric acid anhydrous, D&amp;C yellow No. 10, FD&amp;C red No. 40, hydroxyethyl cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>62795-6001-4</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (62795-6001-4)  *  100 TABLET in 1 BOTTLE (62795-1029-2)  *  50 g in 1 TUBE (62795-7002-7)</PackageDescription>
    <NDC11Code>62795-6001-04</NDC11Code>
    <ProductNDC>62795-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>T-relief Value Pack</ProprietaryName>
    <NonProprietaryName>T-relief</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20140830</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>MediNatura</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-05</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>63804-6001-2</NDCCode>
    <PackageDescription>3785 mL in 1 JUG (63804-6001-2) </PackageDescription>
    <NDC11Code>63804-6001-02</NDC11Code>
    <ProductNDC>63804-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Pisgah labs, inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69640-6001-2</NDCCode>
    <PackageDescription>2 CONTAINER in 1 CARTON (69640-6001-2)  &gt; 15 g in 1 CONTAINER (69640-6001-1)</PackageDescription>
    <NDC11Code>69640-6001-02</NDC11Code>
    <ProductNDC>69640-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Donginbi Red Ginseng Radiance</ProprietaryName>
    <ProprietaryNameSuffix>Cushion Bb 23</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Octisalate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150308</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>KGC LIFE&amp;GIN</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>1.05; .75; 1.88</StrengthNumber>
    <StrengthUnit>g/15g; g/15g; g/15g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <Description>Uses: Press the sponge with built-in puff, take out proper quantity, then apply it along the skin texture, thin and wide, finish with massage. Directions: following the use of base, take a suitable amount on the back of your hand and spread it over your face thinly flowing skin texture.</Description>
  </NDC>
  <NDC>
    <NDCCode>76344-6001-2</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (76344-6001-2)  &gt; 50 mL in 1 TUBE (76344-6001-1)</PackageDescription>
    <NDC11Code>76344-6001-02</NDC11Code>
    <ProductNDC>76344-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Derma Blemish Balm</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130422</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Humex,Inc.</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>6.5; 4.24; 3.5</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2015-01-23</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>76369-6001-2</NDCCode>
    <PackageDescription>300 mL in 1 BOX (76369-6001-2)</PackageDescription>
    <NDC11Code>76369-6001-02</NDC11Code>
    <ProductNDC>76369-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Msm (mosaengmo)</ProprietaryName>
    <NonProprietaryName>Propylene Glycol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111111</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Handock Cosmetics Inc</LabelerName>
    <SubstanceName>PROPYLENE GLYCOL</SubstanceName>
    <StrengthNumber>23.85</StrengthNumber>
    <StrengthUnit>mL/150mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>77419-6001-2</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE, PUMP (77419-6001-2) </PackageDescription>
    <NDC11Code>77419-6001-02</NDC11Code>
    <ProductNDC>77419-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Amass Lavender And Fir Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Lavender And Fir Hand Sanitizer</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201113</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>AMASS Brands, Inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>41.3</StrengthNumber>
    <StrengthUnit>mL/59mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USE Hand sanitizer to help reduce disease-causing bacteria.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0069-6001-21</NDCCode>
    <PackageDescription>10 VIAL in 1 PACKAGE (0069-6001-21)  / 10 mL in 1 VIAL (0069-6001-10) </PackageDescription>
    <NDC11Code>00069-6001-21</NDC11Code>
    <ProductNDC>0069-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cerebyx</ProprietaryName>
    <NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20131028</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020450</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE. The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. CEREBYX is marketed in 2 mL vials containing a total of 100 mg PE/2 mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10 mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. CEREBYX is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12.11 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. CEREBYX is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is. The molecular weight of fosphenytoin is 406.24.</Description>
  </NDC>
  <NDC>
    <NDCCode>0245-6001-11</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0245-6001-11)  / 100 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>00245-6001-11</NDC11Code>
    <ProductNDC>0245-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vigadrone</ProprietaryName>
    <NonProprietaryName>Vigabatrin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230629</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214749</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>VIGABATRIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VIGADRONE is indicated for the treatment of: 1 Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; VIGADRONE is not indicated as a first line agent ( 1.1) , 2 Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2) .</IndicationAndUsage>
    <Description>VIGADRONE (vigabatrin, USP) is an oral antiepileptic drug and is available as a white, film- coated 500 mg tablet. The chemical name of vigabatrin, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6H 11NO 2and the molecular weight is 129.16. It has the following structural formula:. Vigabatrin, USP is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pK a) of vigabatrin are 4 and 9.7 at room temperature (25°C). Each VIGADRONE tablet contains 500 mg of vigabatrin. The inactive ingredients are magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate (potato) and isopropyl alcohol. The tablet coating ingredients are hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide. Approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6001-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0310-6001-30) </PackageDescription>
    <NDC11Code>00310-6001-30</NDC11Code>
    <ProductNDC>0310-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Baxfendy</ProprietaryName>
    <NonProprietaryName>Baxdrostat</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260515</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219878</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>BAXDROSTAT</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BAXFENDY, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction of these events with BAXFENDY. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the American College of Cardiology/American Heart Association (ACC/AHA). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.</IndicationAndUsage>
    <Description>Baxdrostat is an aldosterone synthase inhibitor. The chemical name of baxdrostat is N-[(8R)-4-(1-methyl-2-oxo-1,2,3,4-tetrahydro-6-quinolinyl)-5,6,7,8-tetrahydro-8-isoquinolinyl]propanamide. The molecular formula is C22H25N3O2 and the molecular weight is 363.45 g/mol. The structural formula is. BAXFENDY is available as a film-coated tablet for oral administration, containing 1 mg or 2 mg of baxdrostat. The inactive ingredients in BAXFENDY are croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide, in addition to ferric oxide red (1 mg strength tablets) or ferric oxide yellow (2 mg strength tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>0310-6001-95</NDCCode>
    <PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (0310-6001-95) </PackageDescription>
    <NDC11Code>00310-6001-95</NDC11Code>
    <ProductNDC>0310-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Baxfendy</ProprietaryName>
    <NonProprietaryName>Baxdrostat</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260515</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219878</ApplicationNumber>
    <LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
    <SubstanceName>BAXDROSTAT</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260515</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>BAXFENDY, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction of these events with BAXFENDY. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the American College of Cardiology/American Heart Association (ACC/AHA). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.</IndicationAndUsage>
    <Description>Baxdrostat is an aldosterone synthase inhibitor. The chemical name of baxdrostat is N-[(8R)-4-(1-methyl-2-oxo-1,2,3,4-tetrahydro-6-quinolinyl)-5,6,7,8-tetrahydro-8-isoquinolinyl]propanamide. The molecular formula is C22H25N3O2 and the molecular weight is 363.45 g/mol. The structural formula is. BAXFENDY is available as a film-coated tablet for oral administration, containing 1 mg or 2 mg of baxdrostat. The inactive ingredients in BAXFENDY are croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide, in addition to ferric oxide red (1 mg strength tablets) or ferric oxide yellow (2 mg strength tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-6001-91</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91) </PackageDescription>
    <NDC11Code>00378-6001-91</NDC11Code>
    <ProductNDC>0378-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160823</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200690</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160823</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride extended-release tablets, USP contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is 1,1-Dimethybiguanide monohydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Its structural formula is. Metformin hydrochloride, USP is a white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1000 mg of metformin hydrochloride. In addition to the active ingredient metformin hydrochloride, each tablet contains the following inactive ingredients: cellulose acetate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate and yellow iron oxide. In addition, the black imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Meets USP Dissolution Test 5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0641-6001-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (0641-6001-25)  / 1 mL in 1 VIAL (0641-6001-01) </PackageDescription>
    <NDC11Code>00641-6001-25</NDC11Code>
    <ProductNDC>0641-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ativan</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19800725</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018140</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19800725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ATIVAN Injection is indicated for the treatment of status epilepticus.</IndicationAndUsage>
    <Description>Lorazepam, a benzodiazepine with antianxiety, sedative, and anticonvulsant effects, is intended for the intramuscular or intravenous routes of administration. It has the chemical formula: 7-chloro-5(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1, 4-benzodiazepin-2-one. The molecular weight is 321.16, and the C.A.S. No. is [846-49-1]. The structural formula is. Lorazepam is a nearly white powder almost insoluble in water. Each mL of sterile injection contains either 2.0 or 4.0 mg of lorazepam, 0.18 mL polyethylene glycol 400 in propylene glycol with 2.0% benzyl alcohol as preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>34690-6001-1</NDCCode>
    <PackageDescription>4 g in 1 BOX (34690-6001-1)</PackageDescription>
    <NDC11Code>34690-6001-01</NDC11Code>
    <ProductNDC>34690-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lavender Sap Patch</ProprietaryName>
    <NonProprietaryName>Topical Starch</NonProprietaryName>
    <DosageFormName>POULTICE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>KJI Industrial Co Ltd</LabelerName>
    <SubstanceName>STARCH, CORN</SubstanceName>
    <StrengthNumber>2.92</StrengthNumber>
    <StrengthUnit>g/4g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>34690-6001-3</NDCCode>
    <PackageDescription>4 g in 1 BOX (34690-6001-3)</PackageDescription>
    <NDC11Code>34690-6001-03</NDC11Code>
    <ProductNDC>34690-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lavender Sap Patch</ProprietaryName>
    <NonProprietaryName>Topical Starch</NonProprietaryName>
    <DosageFormName>POULTICE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>KJI Industrial Co Ltd</LabelerName>
    <SubstanceName>STARCH, CORN</SubstanceName>
    <StrengthNumber>2.92</StrengthNumber>
    <StrengthUnit>g/4g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>34690-6001-4</NDCCode>
    <PackageDescription>4 g in 1 BOX (34690-6001-4)</PackageDescription>
    <NDC11Code>34690-6001-04</NDC11Code>
    <ProductNDC>34690-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lavender Sap Patch</ProprietaryName>
    <NonProprietaryName>Topical Starch</NonProprietaryName>
    <DosageFormName>POULTICE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100115</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>KJI Industrial Co Ltd</LabelerName>
    <SubstanceName>STARCH, CORN</SubstanceName>
    <StrengthNumber>2.92</StrengthNumber>
    <StrengthUnit>g/4g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52345-6001-1</NDCCode>
    <PackageDescription>13 mL in 1 CONTAINER (52345-6001-1) </PackageDescription>
    <NDC11Code>52345-6001-01</NDC11Code>
    <ProductNDC>52345-6001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Drop Dream Eye 2</ProprietaryName>
    <NonProprietaryName>Polyhexamethylene Biguanide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>NASAL; OPHTHALMIC</RouteName>
    <StartMarketingDate>20240427</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>K&amp;J.C Co., Ltd</LabelerName>
    <SubstanceName>POLYAMINOPROPYL BIGUANIDE</SubstanceName>
    <StrengthNumber>.001</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>always use fresh solution to disinfacts, to not reuse solution.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52652-6001-1</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (52652-6001-1)  / 120 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>52652-6001-01</NDC11Code>
    <ProductNDC>52652-6001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fleqsuvy</ProprietaryName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220207</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215602</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FLEQSUVY is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. FLEQSUVY may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. FLEQSUVY is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.</IndicationAndUsage>
    <Description>FLEQSUVY (baclofen oral suspension) is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Molecular formula is C 10H 12C1NO 2. Molecular Weight is 213.66 g/mol. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The FLEQSUVY (baclofen oral suspension) inactive ingredients are: artificial grape flavor, citric acid anhydrous, D&amp;C yellow No. 10, FD&amp;C red No. 40, hydroxyethyl cellulose, propylene glycol, purified water, simethicone emulsion, sodium benzoate, and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>57955-0001-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0001-2)</PackageDescription>
    <NDC11Code>57955-0001-02</NDC11Code>
    <ProductNDC>57955-0001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Eating Disorders</ProprietaryName>
    <NonProprietaryName>Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140417</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>King Bio Inc</LabelerName>
    <SubstanceName>ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT</SubstanceName>
    <StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57955-0002-2</NDCCode>
    <PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0002-2)</PackageDescription>
    <NDC11Code>57955-0002-02</NDC11Code>
    <ProductNDC>57955-0002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Birth Ease</ProprietaryName>
    <NonProprietaryName>Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140417</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>King Bio Inc.</LabelerName>
    <SubstanceName>ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK</SubstanceName>
    <StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>57955-6001-2</NDCCode><ProprietaryName>Indoor Air Pollution Detox</ProprietaryName><NonProprietaryName>Acetaldehyde, Ammonium Causticum, Carboneum Oxygenisatum, Chloroformum, Formalinum, Glycyrrhiza Glabra, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Petroleum, Plumbum Metallicum, Taraxacum Officinale</NonProprietaryName></NDC><NDC><NDCCode>0069-6001-25</NDCCode><ProprietaryName>Cerebyx</ProprietaryName><NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName></NDC><NDC><NDCCode>10819-6001-2</NDCCode><ProprietaryName>Sani Professional Brand Sani-hands</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>34605-6001-2</NDCCode><ProprietaryName>Nosmotea</ProprietaryName><NonProprietaryName>Clove Tea</NonProprietaryName></NDC><NDC><NDCCode>34690-6001-2</NDCCode><ProprietaryName>Lavender Sap Patch</ProprietaryName><NonProprietaryName>Topical Starch</NonProprietaryName></NDC><NDC><NDCCode>41525-6001-2</NDCCode><ProprietaryName>Dental Pro</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>44738-6001-2</NDCCode><ProprietaryName>Ginsamin Beauty</ProprietaryName><NonProprietaryName>Ginkgo Leaf Extract</NonProprietaryName></NDC><NDC><NDCCode>47649-6001-2</NDCCode><ProprietaryName>O Blanctis</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>48951-6001-2</NDCCode><ProprietaryName>Juglans Stannum Special Order</ProprietaryName><NonProprietaryName>Juglans Stannum Special Order</NonProprietaryName></NDC><NDC><NDCCode>51754-6001-4</NDCCode><ProprietaryName>Glyrx-pf</ProprietaryName><NonProprietaryName>Glycopyrrolate</NonProprietaryName></NDC><NDC><NDCCode>52652-6001-2</NDCCode><ProprietaryName>Fleqsuvy</ProprietaryName><NonProprietaryName>Baclofen</NonProprietaryName></NDC><NDC><NDCCode>62795-6001-4</NDCCode><ProprietaryName>T-relief Value Pack</ProprietaryName><NonProprietaryName>T-relief</NonProprietaryName></NDC><NDC><NDCCode>63804-6001-2</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>69640-6001-2</NDCCode><ProprietaryName>Donginbi Red Ginseng Radiance</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>76344-6001-2</NDCCode><ProprietaryName>Derma Blemish Balm</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>76369-6001-2</NDCCode><ProprietaryName>Msm (mosaengmo)</ProprietaryName><NonProprietaryName>Propylene Glycol</NonProprietaryName></NDC><NDC><NDCCode>77419-6001-2</NDCCode><ProprietaryName>Amass Lavender And Fir Hand Sanitizer</ProprietaryName><NonProprietaryName>Lavender And Fir Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>0069-6001-21</NDCCode><ProprietaryName>Cerebyx</ProprietaryName><NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName></NDC><NDC><NDCCode>0245-6001-11</NDCCode><ProprietaryName>Vigadrone</ProprietaryName><NonProprietaryName>Vigabatrin</NonProprietaryName></NDC><NDC><NDCCode>0310-6001-30</NDCCode><ProprietaryName>Baxfendy</ProprietaryName><NonProprietaryName>Baxdrostat</NonProprietaryName></NDC><NDC><NDCCode>0310-6001-95</NDCCode><ProprietaryName>Baxfendy</ProprietaryName><NonProprietaryName>Baxdrostat</NonProprietaryName></NDC><NDC><NDCCode>0378-6001-91</NDCCode><ProprietaryName>Metformin Hydrochloride</ProprietaryName><NonProprietaryName>Metformin</NonProprietaryName></NDC><NDC><NDCCode>0641-6001-25</NDCCode><ProprietaryName>Ativan</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>34690-6001-1</NDCCode><ProprietaryName>Lavender Sap Patch</ProprietaryName><NonProprietaryName>Topical Starch</NonProprietaryName></NDC><NDC><NDCCode>34690-6001-3</NDCCode><ProprietaryName>Lavender Sap Patch</ProprietaryName><NonProprietaryName>Topical Starch</NonProprietaryName></NDC><NDC><NDCCode>34690-6001-4</NDCCode><ProprietaryName>Lavender Sap Patch</ProprietaryName><NonProprietaryName>Topical Starch</NonProprietaryName></NDC><NDC><NDCCode>52345-6001-1</NDCCode><ProprietaryName>Drop Dream Eye 2</ProprietaryName><NonProprietaryName>Polyhexamethylene Biguanide</NonProprietaryName></NDC><NDC><NDCCode>52652-6001-1</NDCCode><ProprietaryName>Fleqsuvy</ProprietaryName><NonProprietaryName>Baclofen</NonProprietaryName></NDC><NDC><NDCCode>57955-0001-2</NDCCode><ProprietaryName>Eating Disorders</ProprietaryName><NonProprietaryName>Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album</NonProprietaryName></NDC><NDC><NDCCode>57955-0002-2</NDCCode><ProprietaryName>Birth Ease</ProprietaryName><NonProprietaryName>Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
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      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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