RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "76045-105-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-105-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0105-20",
      "ProductNDC": "76045-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketorolac Tromethamine",
      "NonProprietaryName": "Ketorolac Tromethamine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20151102",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203242",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "KETOROLAC TROMETHAMINE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-09-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151102",
      "SamplePackage": "N",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).",
      "Description": "Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
    },
    {
      "NDCCode": "76045-001-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-001-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-001-00)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0001-20",
      "ProductNDC": "76045-001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midazolam",
      "NonProprietaryName": "Midazolam Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20141003",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203460",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141003",
      "SamplePackage": "N",
      "IndicationAndUsage": "Midazolam injection is indicated: : 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; , 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; , 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); , 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. .",
      "Description": "Midazolam Injection, USP is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is approximately 2.5 to 3.7 and is adjusted with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4 H-imidazo[1,5-a] [1,4] benzodiazepine hydrochloride. Midazolam hydrochloride has the chemical formula C18H13CIFN3·HCl, a calculated molecular weight of 362.25 and the following structural formula:. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form."
    },
    {
      "NDCCode": "76045-003-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-003-20)  > 1 SYRINGE, GLASS in 1 BLISTER PACK > 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0003-20",
      "ProductNDC": "76045-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midazolam",
      "NonProprietaryName": "Midazolam Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20141003",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203460",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20141003",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76045-101-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-101-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-101-00)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0101-20",
      "ProductNDC": "76045-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoclopramide",
      "NonProprietaryName": "Metoclopramide Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20130503",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091392",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130503",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoclopramide Injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.",
      "Description": "Metoclopramide hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Molecular weight: 354.3. C14H22ClN3O2⋅HCl⋅H2O. Metoclopramide Injection, USP is a clear, colorless, sterile solution with a pH of 4.5 to 6.5 for intravenous (IV) or intramuscular (IM) administration. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Each mL contains: metoclopramide base 5 mg (as the monohydrochloride monohydrate), sodium chloride, USP 8.5 mg, Water for Injection, USP q.s. pH adjusted, when necessary with hydrochloric acid and/or sodium hydroxide."
    },
    {
      "NDCCode": "76045-103-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-103-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-103-00)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0103-20",
      "ProductNDC": "76045-103",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20151210",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202253",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: : 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1) , 2 postoperative nausea and/or vomiting. (1.2) .",
      "Description": "The active ingredient in Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0."
    },
    {
      "NDCCode": "76045-112-20",
      "PackageDescription": "24 SYRINGE in 1 CASE (76045-112-20)  / 2 mL in 1 SYRINGE (76045-112-01) ",
      "NDC11Code": "76045-0112-20",
      "ProductNDC": "76045-112",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Naloxone Hydrochloride",
      "NonProprietaryName": "Naloxone Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20240402",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA213573",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "NALOXONE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240402",
      "SamplePackage": "N",
      "IndicationAndUsage": "Naloxone is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone is also indicated for diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).",
      "Description": "Naloxone Hydrochloride Injection, USP, an opioid antagonist, is a synthetic congener of oxymorphone. In structure it differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. Naloxone Hydrochloride Injection is available as a sterile solution for intravenous, intramuscular and subcutaneous administration in two concentrations: 0.4 mg and 1 mg of naloxone hydrochloride per mL. pH is adjusted to 3.5 ± 0.5 with hydrochloric acid. The 0.4 mg/mL prefilled syringe is available in an unpreserved, paraben-free formulation containing 9 mg/mL of sodium chloride. The 1 mg/mL prefilled syringe is available in an unpreserved, paraben-free formulation containing 9 mg/mL of sodium chloride."
    },
    {
      "NDCCode": "76045-203-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-203-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-02)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0203-20",
      "ProductNDC": "76045-203",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glycopyrrolate",
      "NonProprietaryName": "Glycopyrrolate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20180725",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209024",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GLYCOPYRROLATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180725",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.",
      "Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:. Glycopyrrolate, USP 0.2 mg, Water for Injection, USP q.s. pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. Solution does not contain preservatives. Glycopyrrolate is a quaternary ammonium salt with the following chemical name:. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its 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. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log 10 P= -1.52) at ambient room temperature (24°C)."
    },
    {
      "NDCCode": "76045-204-20",
      "PackageDescription": "24 SYRINGE, GLASS in 1 CARTON (76045-204-20)  / 2 mL in 1 SYRINGE, GLASS (76045-204-00) ",
      "NDC11Code": "76045-0204-20",
      "ProductNDC": "76045-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diazepam",
      "NonProprietaryName": "Diazepam",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20221110",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214745",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "DIAZEPAM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2025-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221110",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures. (See WARNINGS.). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam Injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.",
      "Description": "Diazepam Injection, USP is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. Each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% ethyl alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative. pH 6.6 (6.2 to 6.9). Note: Solution is clear, colorless to yellow. Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water with a molecular weight of 284.74 and with the following molecular structure."
    },
    {
      "NDCCode": "76045-208-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-208-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-208-02)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0208-20",
      "ProductNDC": "76045-208",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glycopyrrolate",
      "NonProprietaryName": "Glycopyrrolate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20201030",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209024",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "GLYCOPYRROLATE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201030",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.",
      "Description": "Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:. Glycopyrrolate, USP 0.2 mg, Water for Injection, USP q.s. pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. Solution does not contain preservatives. Glycopyrrolate is a quaternary ammonium salt with the following chemical name:. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its 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. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log 10 P= -1.52) at ambient room temperature (24°C)."
    },
    {
      "NDCCode": "76045-211-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-211-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0211-20",
      "ProductNDC": "76045-211",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Midazolam",
      "NonProprietaryName": "Midazolam Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20210416",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203460",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-01-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210416",
      "SamplePackage": "N",
      "IndicationAndUsage": "Midazolam injection is indicated: : 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; , 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; , 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); , 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. .",
      "Description": "Midazolam Injection, USP is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is approximately 2.5 to 3.7 and is adjusted with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4 H-imidazo[1,5-a] [1,4] benzodiazepine hydrochloride. Midazolam hydrochloride has the chemical formula C18H13CIFN3·HCl, a calculated molecular weight of 362.25 and the following structural formula:. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form."
    },
    {
      "NDCCode": "76045-213-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-213-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-213-00)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0213-20",
      "ProductNDC": "76045-213",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoclopramide",
      "NonProprietaryName": "Metoclopramide Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20130503",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091392",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoclopramide Injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.",
      "Description": "Metoclopramide hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Molecular weight: 354.3. C14H22ClN3O2⋅HCl⋅H2O. Metoclopramide Injection, USP is a clear, colorless, sterile solution with a pH of 4.5 to 6.5 for intravenous (IV) or intramuscular (IM) administration. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Each mL contains: metoclopramide base 5 mg (as the monohydrochloride monohydrate), sodium chloride, USP 8.5 mg, Water for Injection, USP q.s. pH adjusted, when necessary with hydrochloric acid and/or sodium hydroxide."
    },
    {
      "NDCCode": "76045-216-20",
      "PackageDescription": "24 BLISTER PACK in 1 CARTON (76045-216-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00)  / 2 mL in 1 SYRINGE, GLASS",
      "NDC11Code": "76045-0216-20",
      "ProductNDC": "76045-216",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20220531",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202253",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/2mL",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220531",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: : 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1) , 2 postoperative nausea and/or vomiting. (1.2) .",
      "Description": "The active ingredient in Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0."
    },
    {
      "NDCCode": "76045-219-20",
      "PackageDescription": "24 SYRINGE in 1 CARTON (76045-219-20)  / 2 mL in 1 SYRINGE (76045-219-02) ",
      "NDC11Code": "76045-0219-20",
      "ProductNDC": "76045-219",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sugammadex",
      "NonProprietaryName": "Sugammadex",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260728",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA219448",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "SUGAMMADEX SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "gamma-Cyclodextrins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260728",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
      "Description": "Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:."
    },
    {
      "NDCCode": "10927-105-02",
      "PackageDescription": "20 L in 1 DEWAR (10927-105-02) ",
      "NDC11Code": "10927-0105-02",
      "ProductNDC": "10927-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen",
      "NonProprietaryName": "Oxygen",
      "DosageFormName": "LIQUID",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19381020",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205767",
      "LabelerName": "PURITY CYLINDER GASES INC",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "99",
      "StrengthUnit": "1/100L",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "12546-105-20",
      "PackageDescription": "20 LOZENGE in 1 BAG (12546-105-20)",
      "NDC11Code": "12546-0105-20",
      "ProductNDC": "12546-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Halls",
      "ProprietaryNameSuffix": "Mocha Mint",
      "NonProprietaryName": "Menthol",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20131001",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Mondelez Global LLC",
      "SubstanceName": "MENTHOL",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "cough due to a cold. occasional minor irritation or sore throat."
    },
    {
      "NDCCode": "13668-105-20",
      "PackageDescription": "2000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-20) ",
      "NDC11Code": "13668-0105-20",
      "ProductNDC": "13668-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isosorbide Mononitrate",
      "NonProprietaryName": "Isosorbide Mononitrate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110603",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200495",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "ISOSORBIDE MONONITRATE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20110603",
      "SamplePackage": "N",
      "IndicationAndUsage": "Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
      "Description": "Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diethyl phthalate, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The molecular formula of ISMN is C 6H 9NO 6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula:. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. For 30 mg: Meets USP Dissolution Test 6. For 60 mg and 120 mg: Meets USP Dissolution Test 1."
    },
    {
      "NDCCode": "17205-105-00",
      "PackageDescription": "20 kg in 1 DRUM (17205-105-00)",
      "NDC11Code": "17205-0105-00",
      "ProductNDC": "17205-105",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nicotine Bitartrate Dihydrate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20040309",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Siegfried AG",
      "SubstanceName": "NICOTINE BITARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2020-11-14",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "33261-105-20",
      "PackageDescription": "20 TABLET, COATED in 1 BOTTLE (33261-105-20)",
      "NDC11Code": "33261-0105-20",
      "ProductNDC": "33261-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076003",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults.",
      "Description": "Tramadol hydrochloride tablets, USP are a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet, USP intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "42385-105-03",
      "PackageDescription": "20 kg in 1 DRUM (42385-105-03) ",
      "NDC11Code": "42385-0105-03",
      "ProductNDC": "42385-105",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Cyclopentolate Hydrochloride",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20211013",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Laurus Labs Limited",
      "SubstanceName": "CYCLOPENTOLATE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2022-12-20",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "13-OCT-21"
    },
    {
      "NDCCode": "42961-105-02",
      "PackageDescription": "20 PACKET in 1 PACKAGE (42961-105-02)  / 1 LOZENGE in 1 PACKET (42961-105-01) ",
      "NDC11Code": "42961-0105-02",
      "ProductNDC": "42961-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "First Aid Direct Cold-eeze Cold Remedy",
      "NonProprietaryName": "Zinc Gluconate",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230720",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Cintas Corporation",
      "SubstanceName": "ZINC GLUCONATE",
      "StrengthNumber": "2",
      "StrengthUnit": "[hp_X]/1",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Active",
      "LastUpdate": "2025-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230720",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 reduces the duration of the common cold, 2 reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness."
    },
    {
      "NDCCode": "50242-105-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-105-01)  / 20 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "50242-0105-01",
      "ProductNDC": "50242-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Polivy",
      "NonProprietaryName": "Polatuzumab Vedotin",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20190610",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761121",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "POLATUZUMAB VEDOTIN",
      "StrengthNumber": "140",
      "StrengthUnit": "mg/7.52mL",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190610",
      "SamplePackage": "N",
      "IndicationAndUsage": "POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: 1 in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. (1.1), 2 in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. (1.2).",
      "Description": "Polatuzumab vedotin-piiq is a CD79b-directed antibody and microtubule inhibitor conjugate. It consists of three components: 1) the humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b; 2) the small molecule anti-mitotic agent MMAE; and 3) a protease-cleavable linker maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB) that covalently attaches MMAE to the polatuzumab antibody. Polatuzumab vedotin-piiq has an approximate molecular weight of 150 kDa. An average of 3.5 molecules of MMAE are attached to each antibody molecule. Polatuzumab vedotin-piiq is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis. POLIVY (polatuzumab vedotin-piiq) for injection is supplied as a sterile, white to grayish-white, preservative-free, lyophilized powder, which has a cake-like appearance, for intravenous infusion after reconstitution and dilution. Each single-dose 30 mg POLIVY vial delivers 30 mg of polatuzumab vedotin-piiq, polysorbate-20 (1.8 mg), sodium hydroxide (0.82 mg), succinic acid (1.77 mg), and sucrose (62 mg). After reconstitution with 1.8 mL of any of the diluents listed in Table 5, the final concentration is 20 mg/mL with a pH of approximately 5.3. Each single-dose 140 mg POLIVY vial delivers 140 mg of polatuzumab vedotin-piiq, polysorbate-20 (8.4 mg), sodium hydroxide (3.8 mg), succinic acid (8.27 mg), and sucrose (288 mg). After reconstitution with 7.2 mL of any of the diluents listed in Table 5, the final concentration is 20 mg/mL with a pH of approximately 5.3. The POLIVY vial stoppers are not made with natural rubber latex."
    },
    {
      "NDCCode": "51079-105-20",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-105-20)  > 1 TABLET in 1 BLISTER PACK (51079-105-01) ",
      "NDC11Code": "51079-0105-20",
      "ProductNDC": "51079-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Folic Acid",
      "NonProprietaryName": "Folic Acid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110421",
      "EndMarketingDate": "20190731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040756",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "FOLIC ACID",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110421",
      "EndMarketingDatePackage": "20190731",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "51346-105-01",
      "PackageDescription": "20 mL in 1 CARTON (51346-105-01)",
      "NDC11Code": "51346-0105-01",
      "ProductNDC": "51346-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Essential Solution Pearl Mask Sheet",
      "NonProprietaryName": "Glycerin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part347",
      "LabelerName": "NATURE REPUBLIC CO., LTD.",
      "SubstanceName": "GLYCERIN",
      "StrengthNumber": "4",
      "StrengthUnit": "g/20mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-25",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "51414-105-03",
      "PackageDescription": "20 g in 1 BOTTLE (51414-105-03) ",
      "NDC11Code": "51414-0105-03",
      "ProductNDC": "51414-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mouthwash",
      "NonProprietaryName": "Cetylpyridinium Chloride",
      "DosageFormName": "RINSE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20160110",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part356",
      "LabelerName": "Yuyao Jessie Commodity Co.,Ltd.",
      "SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
      "StrengthNumber": ".07",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20161115",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps control plaque that leads to gingivitis and bleeding gums."
    },
    {
      "NDCCode": "52945-069-00",
      "PackageDescription": "2 TRAY in 1 CASE (52945-069-00)  / 105 VIAL in 1 TRAY / 20 mL in 1 VIAL",
      "NDC11Code": "52945-0069-00",
      "ProductNDC": "52945-069",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Bupivacaine",
      "DosageFormName": "INJECTION, SUSPENSION, LIPOSOMAL",
      "StartMarketingDate": "20120101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Patheon UK Limited",
      "SubstanceName": "BUPIVACAINE",
      "StrengthNumber": "13.3",
      "StrengthUnit": "mg/mL",
      "Status": "Unfinished",
      "LastUpdate": "2025-02-07",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "01-JAN-12"
    },
    {
      "NDCCode": "53217-105-20",
      "PackageDescription": "20 TABLET, COATED in 1 BOTTLE (53217-105-20)",
      "NDC11Code": "53217-0105-20",
      "ProductNDC": "53217-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076003",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2017-03-10"
    },
    {
      "NDCCode": "55718-105-01",
      "PackageDescription": "1 VIAL in 1 CARTON (55718-105-01)  > 20 mL in 1 VIAL",
      "NDC11Code": "55718-0105-01",
      "ProductNDC": "55718-105",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Dantrolene Sodium",
      "DosageFormName": "INJECTION, SUSPENSION",
      "StartMarketingDate": "20140723",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Isomedix Operations Inc",
      "SubstanceName": "DANTROLENE SODIUM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/5mL",
      "Status": "Unfinished",
      "LastUpdate": "2020-12-12",
      "ListingRecordCertifiedThrough": "20211231"
    },
    {
      "NDCCode": "57339-105-01",
      "PackageDescription": "1 BAG in 1 BAG (57339-105-01)  > 1 BAG in 1 BAG > 20 kg in 1 BAG",
      "NDC11Code": "57339-0105-01",
      "ProductNDC": "57339-105",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Tylosin Phosphate",
      "DosageFormName": "GRANULE",
      "StartMarketingDate": "20010201",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Ningxia Tairui Pharmaceutical Co.,Ltd.",
      "SubstanceName": "TYLOSIN PHOSPHATE",
      "StrengthNumber": "20",
      "StrengthUnit": "kg/20kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "57896-105-20",
      "PackageDescription": "200 TABLET in 1 BOTTLE (57896-105-20) ",
      "NDC11Code": "57896-0105-20",
      "ProductNDC": "57896-105",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Regular Strength Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Geri-Care Pharmaceutical Corp",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230401",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "58159-105-02",
      "PackageDescription": "20 kg in 1 DRUM (58159-105-02) ",
      "NDC11Code": "58159-0105-02",
      "ProductNDC": "58159-105",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Methenamine Hippurate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20241008",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "METHENAMINE HIPPURATE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2024-10-17",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "08-OCT-24"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"76045-105-20","ProprietaryName":"Ketorolac Tromethamine","NonProprietaryName":"Ketorolac Tromethamine"},{"NDCCode":"76045-001-20","ProprietaryName":"Midazolam","NonProprietaryName":"Midazolam Hydrochloride"},{"NDCCode":"76045-003-20","ProprietaryName":"Midazolam","NonProprietaryName":"Midazolam Hydrochloride"},{"NDCCode":"76045-101-20","ProprietaryName":"Metoclopramide","NonProprietaryName":"Metoclopramide Hydrochloride"},{"NDCCode":"76045-103-20","ProprietaryName":"Ondansetron","NonProprietaryName":"Ondansetron Hydrochloride"},{"NDCCode":"76045-112-20","ProprietaryName":"Naloxone Hydrochloride","NonProprietaryName":"Naloxone Hydrochloride"},{"NDCCode":"76045-203-20","ProprietaryName":"Glycopyrrolate","NonProprietaryName":"Glycopyrrolate"},{"NDCCode":"76045-204-20","ProprietaryName":"Diazepam","NonProprietaryName":"Diazepam"},{"NDCCode":"76045-208-20","ProprietaryName":"Glycopyrrolate","NonProprietaryName":"Glycopyrrolate"},{"NDCCode":"76045-211-20","ProprietaryName":"Midazolam","NonProprietaryName":"Midazolam Hydrochloride"},{"NDCCode":"76045-213-20","ProprietaryName":"Metoclopramide","NonProprietaryName":"Metoclopramide Hydrochloride"},{"NDCCode":"76045-216-20","ProprietaryName":"Ondansetron","NonProprietaryName":"Ondansetron Hydrochloride"},{"NDCCode":"76045-219-20","ProprietaryName":"Sugammadex","NonProprietaryName":"Sugammadex"},{"NDCCode":"10927-105-02","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"12546-105-20","ProprietaryName":"Halls","NonProprietaryName":"Menthol"},{"NDCCode":"13668-105-20","ProprietaryName":"Isosorbide Mononitrate","NonProprietaryName":"Isosorbide Mononitrate"},{"NDCCode":"17205-105-00","NonProprietaryName":"Nicotine Bitartrate Dihydrate"},{"NDCCode":"33261-105-20","ProprietaryName":"Tramadol Hydrochloride","NonProprietaryName":"Tramadol Hydrochloride"},{"NDCCode":"42385-105-03","NonProprietaryName":"Cyclopentolate Hydrochloride"},{"NDCCode":"42961-105-02","ProprietaryName":"First Aid Direct Cold-eeze Cold Remedy","NonProprietaryName":"Zinc Gluconate"},{"NDCCode":"50242-105-01","ProprietaryName":"Polivy","NonProprietaryName":"Polatuzumab Vedotin"},{"NDCCode":"51079-105-20","ProprietaryName":"Folic Acid","NonProprietaryName":"Folic Acid"},{"NDCCode":"51346-105-01","ProprietaryName":"Essential Solution Pearl Mask Sheet","NonProprietaryName":"Glycerin"},{"NDCCode":"51414-105-03","ProprietaryName":"Mouthwash","NonProprietaryName":"Cetylpyridinium Chloride"},{"NDCCode":"52945-069-00","NonProprietaryName":"Bupivacaine"},{"NDCCode":"53217-105-20","ProprietaryName":"Tramadol Hydrochloride","NonProprietaryName":"Tramadol Hydrochloride"},{"NDCCode":"55718-105-01","NonProprietaryName":"Dantrolene Sodium"},{"NDCCode":"57339-105-01","NonProprietaryName":"Tylosin Phosphate"},{"NDCCode":"57896-105-20","ProprietaryName":"Regular Strength Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"58159-105-02","NonProprietaryName":"Methenamine Hippurate"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>76045-105-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-105-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0105-20</NDC11Code>
    <ProductNDC>76045-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
    <NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20151102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203242</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-09-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).</IndicationAndUsage>
    <Description>Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-001-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-001-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-001-00)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0001-20</NDC11Code>
    <ProductNDC>76045-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam</ProprietaryName>
    <NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20141003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203460</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-01-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141003</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Midazolam injection is indicated: : 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; , 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; , 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); , 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. .</IndicationAndUsage>
    <Description>Midazolam Injection, USP is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is approximately 2.5 to 3.7 and is adjusted with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4 H-imidazo[1,5-a] [1,4] benzodiazepine hydrochloride. Midazolam hydrochloride has the chemical formula C18H13CIFN3·HCl, a calculated molecular weight of 362.25 and the following structural formula:. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-003-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-003-20)  &gt; 1 SYRINGE, GLASS in 1 BLISTER PACK &gt; 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0003-20</NDC11Code>
    <ProductNDC>76045-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam</ProprietaryName>
    <NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20141003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203460</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141003</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76045-101-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-101-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-101-00)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0101-20</NDC11Code>
    <ProductNDC>76045-101</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoclopramide</ProprietaryName>
    <NonProprietaryName>Metoclopramide Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20130503</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091392</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130503</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoclopramide Injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.</IndicationAndUsage>
    <Description>Metoclopramide hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Molecular weight: 354.3. C14H22ClN3O2⋅HCl⋅H2O. Metoclopramide Injection, USP is a clear, colorless, sterile solution with a pH of 4.5 to 6.5 for intravenous (IV) or intramuscular (IM) administration. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Each mL contains: metoclopramide base 5 mg (as the monohydrochloride monohydrate), sodium chloride, USP 8.5 mg, Water for Injection, USP q.s. pH adjusted, when necessary with hydrochloric acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-103-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-103-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-103-00)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0103-20</NDC11Code>
    <ProductNDC>76045-103</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20151210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202253</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: : 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1) , 2 postoperative nausea and/or vomiting. (1.2) .</IndicationAndUsage>
    <Description>The active ingredient in Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-112-20</NDCCode>
    <PackageDescription>24 SYRINGE in 1 CASE (76045-112-20)  / 2 mL in 1 SYRINGE (76045-112-01) </PackageDescription>
    <NDC11Code>76045-0112-20</NDC11Code>
    <ProductNDC>76045-112</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20240402</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213573</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240402</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naloxone is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone is also indicated for diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).</IndicationAndUsage>
    <Description>Naloxone Hydrochloride Injection, USP, an opioid antagonist, is a synthetic congener of oxymorphone. In structure it differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. Naloxone Hydrochloride Injection is available as a sterile solution for intravenous, intramuscular and subcutaneous administration in two concentrations: 0.4 mg and 1 mg of naloxone hydrochloride per mL. pH is adjusted to 3.5 ± 0.5 with hydrochloric acid. The 0.4 mg/mL prefilled syringe is available in an unpreserved, paraben-free formulation containing 9 mg/mL of sodium chloride. The 1 mg/mL prefilled syringe is available in an unpreserved, paraben-free formulation containing 9 mg/mL of sodium chloride.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-203-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-203-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-02)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0203-20</NDC11Code>
    <ProductNDC>76045-203</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycopyrrolate</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209024</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.</IndicationAndUsage>
    <Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:. Glycopyrrolate, USP 0.2 mg, Water for Injection, USP q.s. pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. Solution does not contain preservatives. Glycopyrrolate is a quaternary ammonium salt with the following chemical name:. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its 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. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log 10 P= -1.52) at ambient room temperature (24°C).</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-204-20</NDCCode>
    <PackageDescription>24 SYRINGE, GLASS in 1 CARTON (76045-204-20)  / 2 mL in 1 SYRINGE, GLASS (76045-204-00) </PackageDescription>
    <NDC11Code>76045-0204-20</NDC11Code>
    <ProductNDC>76045-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diazepam</ProprietaryName>
    <NonProprietaryName>Diazepam</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221110</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214745</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>DIAZEPAM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221110</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures. (See WARNINGS.). Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam Injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.</IndicationAndUsage>
    <Description>Diazepam Injection, USP is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. Each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% ethyl alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative. pH 6.6 (6.2 to 6.9). Note: Solution is clear, colorless to yellow. Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water with a molecular weight of 284.74 and with the following molecular structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-208-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-208-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-208-02)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0208-20</NDC11Code>
    <ProductNDC>76045-208</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glycopyrrolate</ProprietaryName>
    <NonProprietaryName>Glycopyrrolate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20201030</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209024</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201030</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.</IndicationAndUsage>
    <Description>Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:. Glycopyrrolate, USP 0.2 mg, Water for Injection, USP q.s. pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. Solution does not contain preservatives. Glycopyrrolate is a quaternary ammonium salt with the following chemical name:. 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. Its 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. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate Injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log 10 P= -1.52) at ambient room temperature (24°C).</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-211-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-211-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0211-20</NDC11Code>
    <ProductNDC>76045-211</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Midazolam</ProprietaryName>
    <NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20210416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203460</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-01-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Midazolam injection is indicated: : 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; , 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; , 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); , 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. .</IndicationAndUsage>
    <Description>Midazolam Injection, USP is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is approximately 2.5 to 3.7 and is adjusted with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4 H-imidazo[1,5-a] [1,4] benzodiazepine hydrochloride. Midazolam hydrochloride has the chemical formula C18H13CIFN3·HCl, a calculated molecular weight of 362.25 and the following structural formula:. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-213-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-213-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-213-00)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0213-20</NDC11Code>
    <ProductNDC>76045-213</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoclopramide</ProprietaryName>
    <NonProprietaryName>Metoclopramide Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20130503</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091392</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoclopramide Injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.</IndicationAndUsage>
    <Description>Metoclopramide hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Molecular weight: 354.3. C14H22ClN3O2⋅HCl⋅H2O. Metoclopramide Injection, USP is a clear, colorless, sterile solution with a pH of 4.5 to 6.5 for intravenous (IV) or intramuscular (IM) administration. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Each mL contains: metoclopramide base 5 mg (as the monohydrochloride monohydrate), sodium chloride, USP 8.5 mg, Water for Injection, USP q.s. pH adjusted, when necessary with hydrochloric acid and/or sodium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-216-20</NDCCode>
    <PackageDescription>24 BLISTER PACK in 1 CARTON (76045-216-20)  / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00)  / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>76045-0216-20</NDC11Code>
    <ProductNDC>76045-216</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20220531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202253</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of: : 1 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1) , 2 postoperative nausea and/or vomiting. (1.2) .</IndicationAndUsage>
    <Description>The active ingredient in Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:. The empirical formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>76045-219-20</NDCCode>
    <PackageDescription>24 SYRINGE in 1 CARTON (76045-219-20)  / 2 mL in 1 SYRINGE (76045-219-02) </PackageDescription>
    <NDC11Code>76045-0219-20</NDC11Code>
    <ProductNDC>76045-219</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219448</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>10927-105-02</NDCCode>
    <PackageDescription>20 L in 1 DEWAR (10927-105-02) </PackageDescription>
    <NDC11Code>10927-0105-02</NDC11Code>
    <ProductNDC>10927-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19381020</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205767</ApplicationNumber>
    <LabelerName>PURITY CYLINDER GASES INC</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>1/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>12546-105-20</NDCCode>
    <PackageDescription>20 LOZENGE in 1 BAG (12546-105-20)</PackageDescription>
    <NDC11Code>12546-0105-20</NDC11Code>
    <ProductNDC>12546-105</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Halls</ProprietaryName>
    <ProprietaryNameSuffix>Mocha Mint</ProprietaryNameSuffix>
    <NonProprietaryName>Menthol</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Mondelez Global LLC</LabelerName>
    <SubstanceName>MENTHOL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>cough due to a cold. occasional minor irritation or sore throat.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13668-105-20</NDCCode>
    <PackageDescription>2000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-20) </PackageDescription>
    <NDC11Code>13668-0105-20</NDC11Code>
    <ProductNDC>13668-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
    <NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200495</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
    <Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diethyl phthalate, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The molecular formula of ISMN is C 6H 9NO 6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula:. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. For 30 mg: Meets USP Dissolution Test 6. For 60 mg and 120 mg: Meets USP Dissolution Test 1.</Description>
  </NDC>
  <NDC>
    <NDCCode>17205-105-00</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (17205-105-00)</PackageDescription>
    <NDC11Code>17205-0105-00</NDC11Code>
    <ProductNDC>17205-105</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nicotine Bitartrate Dihydrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20040309</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Siegfried AG</LabelerName>
    <SubstanceName>NICOTINE BITARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-11-14</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>33261-105-20</NDCCode>
    <PackageDescription>20 TABLET, COATED in 1 BOTTLE (33261-105-20)</PackageDescription>
    <NDC11Code>33261-0105-20</NDC11Code>
    <ProductNDC>33261-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets, USP are a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular formula of tramadol hydrochloride is C16H25NO2HCl and its molecular weight is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet, USP intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-105-03</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (42385-105-03) </PackageDescription>
    <NDC11Code>42385-0105-03</NDC11Code>
    <ProductNDC>42385-105</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cyclopentolate Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20211013</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>CYCLOPENTOLATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-12-20</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>13-OCT-21</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>42961-105-02</NDCCode>
    <PackageDescription>20 PACKET in 1 PACKAGE (42961-105-02)  / 1 LOZENGE in 1 PACKET (42961-105-01) </PackageDescription>
    <NDC11Code>42961-0105-02</NDC11Code>
    <ProductNDC>42961-105</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>First Aid Direct Cold-eeze Cold Remedy</ProprietaryName>
    <NonProprietaryName>Zinc Gluconate</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230720</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Cintas Corporation</LabelerName>
    <SubstanceName>ZINC GLUCONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 reduces the duration of the common cold, 2 reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50242-105-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50242-105-01)  / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>50242-0105-01</NDC11Code>
    <ProductNDC>50242-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Polivy</ProprietaryName>
    <NonProprietaryName>Polatuzumab Vedotin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190610</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761121</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <SubstanceName>POLATUZUMAB VEDOTIN</SubstanceName>
    <StrengthNumber>140</StrengthNumber>
    <StrengthUnit>mg/7.52mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: 1 in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. (1.1), 2 in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. (1.2).</IndicationAndUsage>
    <Description>Polatuzumab vedotin-piiq is a CD79b-directed antibody and microtubule inhibitor conjugate. It consists of three components: 1) the humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b; 2) the small molecule anti-mitotic agent MMAE; and 3) a protease-cleavable linker maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB) that covalently attaches MMAE to the polatuzumab antibody. Polatuzumab vedotin-piiq has an approximate molecular weight of 150 kDa. An average of 3.5 molecules of MMAE are attached to each antibody molecule. Polatuzumab vedotin-piiq is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis. POLIVY (polatuzumab vedotin-piiq) for injection is supplied as a sterile, white to grayish-white, preservative-free, lyophilized powder, which has a cake-like appearance, for intravenous infusion after reconstitution and dilution. Each single-dose 30 mg POLIVY vial delivers 30 mg of polatuzumab vedotin-piiq, polysorbate-20 (1.8 mg), sodium hydroxide (0.82 mg), succinic acid (1.77 mg), and sucrose (62 mg). After reconstitution with 1.8 mL of any of the diluents listed in Table 5, the final concentration is 20 mg/mL with a pH of approximately 5.3. Each single-dose 140 mg POLIVY vial delivers 140 mg of polatuzumab vedotin-piiq, polysorbate-20 (8.4 mg), sodium hydroxide (3.8 mg), succinic acid (8.27 mg), and sucrose (288 mg). After reconstitution with 7.2 mL of any of the diluents listed in Table 5, the final concentration is 20 mg/mL with a pH of approximately 5.3. The POLIVY vial stoppers are not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>51079-105-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (51079-105-20)  &gt; 1 TABLET in 1 BLISTER PACK (51079-105-01) </PackageDescription>
    <NDC11Code>51079-0105-20</NDC11Code>
    <ProductNDC>51079-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Folic Acid</ProprietaryName>
    <NonProprietaryName>Folic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110421</StartMarketingDate>
    <EndMarketingDate>20190731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040756</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>FOLIC ACID</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110421</StartMarketingDatePackage>
    <EndMarketingDatePackage>20190731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>51346-105-01</NDCCode>
    <PackageDescription>20 mL in 1 CARTON (51346-105-01)</PackageDescription>
    <NDC11Code>51346-0105-01</NDC11Code>
    <ProductNDC>51346-105</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Essential Solution Pearl Mask Sheet</ProprietaryName>
    <NonProprietaryName>Glycerin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part347</ApplicationNumber>
    <LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
    <SubstanceName>GLYCERIN</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-25</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51414-105-03</NDCCode>
    <PackageDescription>20 g in 1 BOTTLE (51414-105-03) </PackageDescription>
    <NDC11Code>51414-0105-03</NDC11Code>
    <ProductNDC>51414-105</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mouthwash</ProprietaryName>
    <NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
    <DosageFormName>RINSE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20160110</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>Yuyao Jessie Commodity Co.,Ltd.</LabelerName>
    <SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.07</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps control plaque that leads to gingivitis and bleeding gums.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>52945-069-00</NDCCode>
    <PackageDescription>2 TRAY in 1 CASE (52945-069-00)  / 105 VIAL in 1 TRAY / 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>52945-0069-00</NDC11Code>
    <ProductNDC>52945-069</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Bupivacaine</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION, LIPOSOMAL</DosageFormName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon UK Limited</LabelerName>
    <SubstanceName>BUPIVACAINE</SubstanceName>
    <StrengthNumber>13.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-02-07</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-12</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>53217-105-20</NDCCode>
    <PackageDescription>20 TABLET, COATED in 1 BOTTLE (53217-105-20)</PackageDescription>
    <NDC11Code>53217-0105-20</NDC11Code>
    <ProductNDC>53217-105</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2017-03-10</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>55718-105-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (55718-105-01)  &gt; 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>55718-0105-01</NDC11Code>
    <ProductNDC>55718-105</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Dantrolene Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <StartMarketingDate>20140723</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Isomedix Operations Inc</LabelerName>
    <SubstanceName>DANTROLENE SODIUM</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2020-12-12</LastUpdate>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>57339-105-01</NDCCode>
    <PackageDescription>1 BAG in 1 BAG (57339-105-01)  &gt; 1 BAG in 1 BAG &gt; 20 kg in 1 BAG</PackageDescription>
    <NDC11Code>57339-0105-01</NDC11Code>
    <ProductNDC>57339-105</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Tylosin Phosphate</NonProprietaryName>
    <DosageFormName>GRANULE</DosageFormName>
    <StartMarketingDate>20010201</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Ningxia Tairui Pharmaceutical Co.,Ltd.</LabelerName>
    <SubstanceName>TYLOSIN PHOSPHATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>kg/20kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>57896-105-20</NDCCode>
    <PackageDescription>200 TABLET in 1 BOTTLE (57896-105-20) </PackageDescription>
    <NDC11Code>57896-0105-20</NDC11Code>
    <ProductNDC>57896-105</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Regular Strength Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230401</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Geri-Care Pharmaceutical Corp</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>58159-105-02</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (58159-105-02) </PackageDescription>
    <NDC11Code>58159-0105-02</NDC11Code>
    <ProductNDC>58159-105</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Methenamine Hippurate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20241008</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>METHENAMINE HIPPURATE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-10-17</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>08-OCT-24</StartMarketingDatePackage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>76045-105-20</NDCCode><ProprietaryName>Ketorolac Tromethamine</ProprietaryName><NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName></NDC><NDC><NDCCode>76045-001-20</NDCCode><ProprietaryName>Midazolam</ProprietaryName><NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76045-003-20</NDCCode><ProprietaryName>Midazolam</ProprietaryName><NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76045-101-20</NDCCode><ProprietaryName>Metoclopramide</ProprietaryName><NonProprietaryName>Metoclopramide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76045-103-20</NDCCode><ProprietaryName>Ondansetron</ProprietaryName><NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76045-112-20</NDCCode><ProprietaryName>Naloxone Hydrochloride</ProprietaryName><NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76045-203-20</NDCCode><ProprietaryName>Glycopyrrolate</ProprietaryName><NonProprietaryName>Glycopyrrolate</NonProprietaryName></NDC><NDC><NDCCode>76045-204-20</NDCCode><ProprietaryName>Diazepam</ProprietaryName><NonProprietaryName>Diazepam</NonProprietaryName></NDC><NDC><NDCCode>76045-208-20</NDCCode><ProprietaryName>Glycopyrrolate</ProprietaryName><NonProprietaryName>Glycopyrrolate</NonProprietaryName></NDC><NDC><NDCCode>76045-211-20</NDCCode><ProprietaryName>Midazolam</ProprietaryName><NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76045-213-20</NDCCode><ProprietaryName>Metoclopramide</ProprietaryName><NonProprietaryName>Metoclopramide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76045-216-20</NDCCode><ProprietaryName>Ondansetron</ProprietaryName><NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76045-219-20</NDCCode><ProprietaryName>Sugammadex</ProprietaryName><NonProprietaryName>Sugammadex</NonProprietaryName></NDC><NDC><NDCCode>10927-105-02</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>12546-105-20</NDCCode><ProprietaryName>Halls</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>13668-105-20</NDCCode><ProprietaryName>Isosorbide Mononitrate</ProprietaryName><NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName></NDC><NDC><NDCCode>17205-105-00</NDCCode><NonProprietaryName>Nicotine Bitartrate Dihydrate</NonProprietaryName></NDC><NDC><NDCCode>33261-105-20</NDCCode><ProprietaryName>Tramadol Hydrochloride</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42385-105-03</NDCCode><NonProprietaryName>Cyclopentolate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>42961-105-02</NDCCode><ProprietaryName>First Aid Direct Cold-eeze Cold Remedy</ProprietaryName><NonProprietaryName>Zinc Gluconate</NonProprietaryName></NDC><NDC><NDCCode>50242-105-01</NDCCode><ProprietaryName>Polivy</ProprietaryName><NonProprietaryName>Polatuzumab Vedotin</NonProprietaryName></NDC><NDC><NDCCode>51079-105-20</NDCCode><ProprietaryName>Folic Acid</ProprietaryName><NonProprietaryName>Folic Acid</NonProprietaryName></NDC><NDC><NDCCode>51346-105-01</NDCCode><ProprietaryName>Essential Solution Pearl Mask Sheet</ProprietaryName><NonProprietaryName>Glycerin</NonProprietaryName></NDC><NDC><NDCCode>51414-105-03</NDCCode><ProprietaryName>Mouthwash</ProprietaryName><NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName></NDC><NDC><NDCCode>52945-069-00</NDCCode><NonProprietaryName>Bupivacaine</NonProprietaryName></NDC><NDC><NDCCode>53217-105-20</NDCCode><ProprietaryName>Tramadol Hydrochloride</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55718-105-01</NDCCode><NonProprietaryName>Dantrolene Sodium</NonProprietaryName></NDC><NDC><NDCCode>57339-105-01</NDCCode><NonProprietaryName>Tylosin Phosphate</NonProprietaryName></NDC><NDC><NDCCode>57896-105-20</NDCCode><ProprietaryName>Regular Strength Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>58159-105-02</NDCCode><NonProprietaryName>Methenamine Hippurate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "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": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "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": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "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": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-562-2015",
      "PracticeLocationAddressFaxNumber": "425-562-2010",
      "EnumerationDate": "10/26/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "WONG",
      "AuthorizedOfficialFirstName": "TONY",
      "AuthorizedOfficialTitle": "OPTOMETRIST",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-562-2015",
      "TaxonomyCode1": "152W00000X",
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      "TaxonomyCode1": "1223G0001X",
      "Taxonomy1": "General Practice",
      "LicenseNumber1": "DN15582",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "122300000X",
      "Taxonomy2": "Dentist",
      "LicenseNumber2": "DN15582",
      "LicenseNumberStateCode2": "FL",
      "PrimaryTaxonomySwitch2": "Y",
      "OtherIdentifier1": "075156100",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "FL"
    },
    {
      "NPI": "1720032899",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ALBATAINEH",
      "FirstName": "RANIA",
      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
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}
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