RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "67457-217-20",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20)  / 20 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "67457-0217-20",
      "ProductNDC": "67457-217",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methadone Hydrochloride",
      "NonProprietaryName": "Methadone Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
      "StartMarketingDate": "20100517",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021624",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "METHADONE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20100517",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration (see WARNINGS), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. 2.For use in temporary treatment of opioid dependence in patients unable to take oral medication.Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.",
      "Description": "Methadone Hydrochloride Injection USP, 10 mg/mL is an opioid analgesic for parenteral use (intravenous, intramuscular or subcutaneous use). Methadone Hydrochloride Injection USP, 10 mg/mL contains methadone hydrochloride as the active pharmaceutical ingredient. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. Methadone hydrochloride has the following structural formula. Methadone Hydrochloride Injection is a sterile injectable solution available in 20 mL multiple-dose vials. Each mL of the Methadone Hydrochloride Injection contains: 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone free base), 5 mg of chlorobutanol, as a preservative, 9 mg of sodium chloride, as tonicity agent, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. The pH of the sterile injectable solution is between 3.0 to 6.5."
    },
    {
      "NDCCode": "31722-217-31",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (31722-217-31)  / 20 mL in 1 VIAL, MULTI-DOSE (31722-217-20) ",
      "NDC11Code": "31722-0217-31",
      "ProductNDC": "31722-217",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine Hydrochloride",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20211108",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA214336",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231213",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
      "Description": "Lidocaine hydrochloride injection contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride is by injection, for infiltration, nerve block, use. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks.  Lidocaine hydrochloride, is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight of 270.8 g/mol. Lidocaine hydrochloride molecular formula is C 14H 22N 2O  HCl, and has the following structural formula:. Lidocaine hydrochloride injection in multiple dose vials is a sterile, nonpyrogenic, isotonic, clear, colorless solution containing lidocaine hydrochloride and sodium chloride. Each mL contains 1 mg methylparaben as an antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. £ Quantity is equivalent to 10.66 mg/mL Lidocaine Hydrochloride, USP (Monohydrate). μ Quantity is equivalent to 21.33 mg/mL Lidocaine Hydrochloride, USP (Monohydrate)."
    },
    {
      "NDCCode": "47682-217-71",
      "PackageDescription": "20 PACKET in 1 BOX (47682-217-71)  / 10 mL in 1 PACKET",
      "NDC11Code": "47682-0217-71",
      "ProductNDC": "47682-217",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medique Guaicon Dms",
      "NonProprietaryName": "Guaifenesin, Dextromethorphan Hbr",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110405",
      "EndMarketingDate": "20230901",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "UNIFIRST FIRST AID CORPORATION",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
      "StrengthNumber": "10; 100",
      "StrengthUnit": "mg/5mL; mg/5mL",
      "Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110405",
      "EndMarketingDatePackage": "20230901",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "47993-217-02",
      "PackageDescription": "20 mL in 1 BOTTLE (47993-217-02) ",
      "NDC11Code": "47993-0217-02",
      "ProductNDC": "47993-217",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer",
      "NonProprietaryName": "Hand Sanitizer",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "g/112mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20200330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: Reduces bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "50563-217-01",
      "PackageDescription": "3 PACKET in 1 PACKAGE (50563-217-01)  > 20 SOLUTION in 1 PACKET",
      "NDC11Code": "50563-0217-01",
      "ProductNDC": "50563-217",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Body Prescriptions Vitamin C Travel Pack Antibacterial Hand Wipes",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200612",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "ENCHANTE ACCESSORIES INC.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "4.5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200612",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ To decrease bacteria on hands."
    },
    {
      "NDCCode": "51079-217-20",
      "PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-217-20)  > 1 TABLET in 1 BLISTER PACK (51079-217-01)",
      "NDC11Code": "51079-0217-20",
      "ProductNDC": "51079-217",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070044",
      "LabelerName": "Mylan Institutional Inc.",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-04-13"
    },
    {
      "NDCCode": "53217-217-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (53217-217-20)",
      "NDC11Code": "53217-0217-20",
      "ProductNDC": "53217-217",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin",
      "NonProprietaryName": "Amoxicillin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA064076",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "AMOXICILLIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of  H. pylori infection and duodenal ulcer disease. (1.5)  .",
      "Description": "Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[(R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S  3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum."
    },
    {
      "NDCCode": "58602-217-20",
      "PackageDescription": "1 BOTTLE in 1 CARTON (58602-217-20)  > 237 mL in 1 BOTTLE",
      "NDC11Code": "58602-0217-20",
      "ProductNDC": "58602-217",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aurophen Pain Away Plus Sleep Aid",
      "NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150505",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Aurohealth LLC",
      "SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "500; 25",
      "StrengthUnit": "mg/15mL; mg/15mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20150505",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60793-217-20",
      "PackageDescription": "1 KIT in 1 CARTON (60793-217-20)  *  20 mL in 1 VIAL, GLASS (60793-317-01)  *  20 mL in 1 VIAL, GLASS (60793-221-09) ",
      "NDC11Code": "60793-0217-20",
      "ProductNDC": "60793-217",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Thrombin-jmi",
      "NonProprietaryName": "Thrombin, Topical (bovine)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19950224",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102865",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "Status": "Active",
      "LastUpdate": "2026-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950224",
      "SamplePackage": "N",
      "IndicationAndUsage": "THROMBIN-JMI is a topical bovine thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. In various types of surgeries, solutions of THROMBIN-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.",
      "Description": "THROMBIN-JMI, Thrombin, Topical (Bovine), is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The product contains no preservative. THROMBIN-JMI undergoes multistep chromatographic purification and ultrafiltration. The manufacturing process for THROMBIN-JMI has been further improved by the addition of viral filtration and impurity reduction processes. Analytical studies demonstrate the capability of the current manufacturing process to remove significant amounts of extraneous proteins, and result in a reduction of factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay (<92 ng/mL, when reconstituted as directed). The clinical relevance of these findings is unknown."
    },
    {
      "NDCCode": "60793-217-21",
      "PackageDescription": "1 KIT in 1 CARTON (60793-217-21)  *  20 mL in 1 VIAL, GLASS (60793-317-01)  *  20 mL in 1 VIAL, GLASS (60793-221-09) ",
      "NDC11Code": "60793-0217-21",
      "ProductNDC": "60793-217",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Thrombin-jmi",
      "NonProprietaryName": "Thrombin, Topical (bovine)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19950224",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102865",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "Status": "Active",
      "LastUpdate": "2026-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950224",
      "SamplePackage": "N",
      "IndicationAndUsage": "THROMBIN-JMI is a topical bovine thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. In various types of surgeries, solutions of THROMBIN-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.",
      "Description": "THROMBIN-JMI, Thrombin, Topical (Bovine), is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The product contains no preservative. THROMBIN-JMI undergoes multistep chromatographic purification and ultrafiltration. The manufacturing process for THROMBIN-JMI has been further improved by the addition of viral filtration and impurity reduction processes. Analytical studies demonstrate the capability of the current manufacturing process to remove significant amounts of extraneous proteins, and result in a reduction of factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay (<92 ng/mL, when reconstituted as directed). The clinical relevance of these findings is unknown."
    },
    {
      "NDCCode": "60793-217-22",
      "PackageDescription": "1 KIT in 1 CARTON (60793-217-22)  *  20 mL in 1 VIAL, GLASS (60793-317-01)  *  20 mL in 1 VIAL, GLASS (60793-221-09) ",
      "NDC11Code": "60793-0217-22",
      "ProductNDC": "60793-217",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Thrombin-jmi",
      "NonProprietaryName": "Thrombin, Topical (bovine)",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19950224",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102865",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "Status": "Active",
      "LastUpdate": "2026-09-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19950224",
      "SamplePackage": "N",
      "IndicationAndUsage": "THROMBIN-JMI is a topical bovine thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. In various types of surgeries, solutions of THROMBIN-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.",
      "Description": "THROMBIN-JMI, Thrombin, Topical (Bovine), is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The product contains no preservative. THROMBIN-JMI undergoes multistep chromatographic purification and ultrafiltration. The manufacturing process for THROMBIN-JMI has been further improved by the addition of viral filtration and impurity reduction processes. Analytical studies demonstrate the capability of the current manufacturing process to remove significant amounts of extraneous proteins, and result in a reduction of factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay (<92 ng/mL, when reconstituted as directed). The clinical relevance of these findings is unknown."
    },
    {
      "NDCCode": "63868-217-20",
      "PackageDescription": "1 BOTTLE in 1 CARTON (63868-217-20)  > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE",
      "NDC11Code": "63868-0217-20",
      "ProductNDC": "63868-217",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Regular Strength Pain Relief",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170713",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Chain Drug Marketing Association Inc.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170713",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headachemuscular achesbackacheminor pain of arthritisthe common coldtoothachepremenstrual and menstrual cramps. temporarily reduces fever."
    },
    {
      "NDCCode": "64220-217-07",
      "PackageDescription": "20 kg in 1 DRUM (64220-217-07) ",
      "NDC11Code": "64220-0217-07",
      "ProductNDC": "64220-217",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Oseltamivir Phosphate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20250513",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
      "SubstanceName": "OSELTAMIVIR PHOSPHATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-05-14",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "13-MAY-25"
    },
    {
      "NDCCode": "67544-217-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-20) ",
      "NDC11Code": "67544-0217-20",
      "ProductNDC": "67544-217",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Temazepam",
      "NonProprietaryName": "Temazepam",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121025",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070920",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "TEMAZEPAM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2021-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20150614",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69842-217-15",
      "PackageDescription": "20 BLISTER PACK in 1 CARTON (69842-217-15)  / 1 GUM, CHEWING in 1 BLISTER PACK",
      "NDC11Code": "69842-0217-15",
      "ProductNDC": "69842-217",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nicotine Polacrilex",
      "ProprietaryNameSuffix": "Coated Ice Mint",
      "NonProprietaryName": "Nicotine Polacrilex Gum",
      "DosageFormName": "GUM, CHEWING",
      "RouteName": "BUCCAL",
      "StartMarketingDate": "20160501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204833",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "NICOTINE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
      "Status": "Active",
      "LastUpdate": "2024-10-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160501",
      "SamplePackage": "N",
      "IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
    },
    {
      "NDCCode": "72603-217-25",
      "PackageDescription": "25 VIAL in 1 CARTON (72603-217-25)  / 20 mL in 1 VIAL (72603-217-01) ",
      "NDC11Code": "72603-0217-25",
      "ProductNDC": "72603-217",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ropivacaine Hydrochloride",
      "NonProprietaryName": "Ropivacaine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20240301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212808",
      "LabelerName": "NorthStar Rx LLC",
      "SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management.Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltrationAcute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
      "Description": "Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.0 mg, 5.0 mg, 10 mg of Ropivacaine Hydrochloride (equivalent to 2.1 mg, 5.3 mg, 10.6 mg Ropivacaine Hydrochloride monohydrate), and 8.6 mg, 8.0 mg, 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C."
    },
    {
      "NDCCode": "76138-217-06",
      "PackageDescription": "20 mL in 1 BOTTLE, PLASTIC (76138-217-06) ",
      "NDC11Code": "76138-0217-06",
      "ProductNDC": "76138-217",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "5299 Sunscreen",
      "NonProprietaryName": "Octocrylene, Titanium Dioxide, Octisalate",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180601",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Innovation Specialties",
      "SubstanceName": "OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE",
      "StrengthNumber": "5; 9; 7",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-05-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180601",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76420-217-20",
      "PackageDescription": "20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-217-20) ",
      "NDC11Code": "76420-0217-20",
      "ProductNDC": "76420-217",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron",
      "NonProprietaryName": "Ondansetron",
      "DosageFormName": "TABLET, ORALLY DISINTEGRATING",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100412",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090469",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "ONDANSETRON",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-02-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220720",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy, 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.",
      "Description": "The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula: The molecular formula is C 18H 19N 3O representing a molecular weight of 293.4 g/mol. Ondansetron is a white to off-white powder. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing. Meets USP Disintegration Test 2."
    },
    {
      "NDCCode": "67457-181-20",
      "PackageDescription": "10 VIAL in 1 CARTON (67457-181-20)  / 20 mL in 1 VIAL (67457-181-00) ",
      "NDC11Code": "67457-0181-20",
      "ProductNDC": "67457-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ketamine Hydrochloride",
      "NonProprietaryName": "Ketamine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20130604",
      "EndMarketingDate": "20231031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076092",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "KETAMINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2023-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20130604",
      "EndMarketingDatePackage": "20231031",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67457-183-20",
      "PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (67457-183-20)  > 20 mL in 1 VIAL, SINGLE-USE (67457-183-99)",
      "NDC11Code": "67457-0183-20",
      "ProductNDC": "67457-183",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Etomidate",
      "NonProprietaryName": "Etomidate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20130426",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091297",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "ETOMIDATE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "General Anesthesia [PE],General Anesthetic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-05-10",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "67457-222-20",
      "PackageDescription": "10 VIAL, GLASS in 1 CARTON (67457-222-20)  > 20 mL in 1 VIAL, GLASS (67457-222-00)",
      "NDC11Code": "67457-0222-20",
      "ProductNDC": "67457-222",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20080630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065401",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Glycopeptide Antibacterial [EPC],Glycopeptides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-01-11",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "67457-280-20",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-280-20)  > 20 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "67457-0280-20",
      "ProductNDC": "67457-280",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Labetalol Hydrochloride",
      "NonProprietaryName": "Labetalol",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20120629",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090699",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "LABETALOL HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-25"
    },
    {
      "NDCCode": "67457-316-25",
      "PackageDescription": "1 VIAL in 1 CARTON (67457-316-25)  > 20 mL in 1 VIAL",
      "NDC11Code": "67457-0316-25",
      "ProductNDC": "67457-316",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Decitabine",
      "NonProprietaryName": "Decitabine",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20181010",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204607",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "DECITABINE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2020-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20181010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.",
      "Description": "Decitabine is nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C 8H 12N 4O 4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1 H)-one and it has the following structural formula:. Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for injection (decitabine), for a intravenous use, is a sterile white to almost white, lyophilized powder supplied in a clear colorless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and /or hydrochloric acid are used for pH adjustment."
    },
    {
      "NDCCode": "67457-326-05",
      "PackageDescription": "20 mL in 1 VIAL, SINGLE-DOSE (67457-326-05) ",
      "NDC11Code": "67457-0326-05",
      "ProductNDC": "67457-326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bendamustine Hydrochloride",
      "NonProprietaryName": "Bendamustine Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180426",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204104",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "BENDAMUSTINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-02-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180426",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67457-340-01",
      "PackageDescription": "10 VIAL in 1 CARTON (67457-340-01)  / 20 mL in 1 VIAL (67457-340-00) ",
      "NDC11Code": "67457-0340-01",
      "ProductNDC": "67457-340",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vancomycin Hydrochloride",
      "NonProprietaryName": "Vancomycin Hydrochloride",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20131205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065397",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/20mL",
      "Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20131205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis.  Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
      "Description": "Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30, 32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m] [10,2,16]benzoxadiazacyclotetracosine -26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24  HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula."
    },
    {
      "NDCCode": "67457-386-81",
      "PackageDescription": "4 VIAL in 1 CARTON (67457-386-81)  / 20 mL in 1 VIAL (67457-386-00) ",
      "NDC11Code": "67457-0386-81",
      "ProductNDC": "67457-386",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mycophenolate Mofetil",
      "NonProprietaryName": "Mycophenolate Mofetil",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210126",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203859",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "MYCOPHENOLATE MOFETIL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/20mL",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.",
      "Description": "Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white or almost white, crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.7 to 4.1. Mycophenolate mofetil for injection, USP is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. Mycophenolate mofetil for injection, USP is available as a sterile white to off-white lyophilized powder, plug or cake in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil, USP equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of mycophenolate mofetil for injection to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)]."
    },
    {
      "NDCCode": "67457-397-99",
      "PackageDescription": "10 VIAL in 1 CARTON (67457-397-99)  > 2 mL in 1 VIAL (67457-397-20) ",
      "NDC11Code": "67457-0397-99",
      "ProductNDC": "67457-397",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranitidine",
      "NonProprietaryName": "Ranitidine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20180817",
      "EndMarketingDate": "20210630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079076",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "RANITIDINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20180817",
      "EndMarketingDatePackage": "20210630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67457-429-20",
      "PackageDescription": "1 VIAL in 1 CARTON (67457-429-20)  > 20 mL in 1 VIAL",
      "NDC11Code": "67457-0429-20",
      "ProductNDC": "67457-429",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ifosfamide",
      "NonProprietaryName": "Ifosfamide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20121127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201689",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "IFOSFAMIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-20",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "67457-441-20",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-441-20)  > 20 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "67457-0441-20",
      "ProductNDC": "67457-441",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20141229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090648",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-12-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20141229",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67457-442-20",
      "PackageDescription": "1 VIAL in 1 CARTON (67457-442-20)  / 20 mL in 1 VIAL",
      "NDC11Code": "67457-0442-20",
      "ProductNDC": "67457-442",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxaliplatin",
      "NonProprietaryName": "Oxaliplatin",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20140516",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091358",
      "LabelerName": "Mylan Institutional LLC",
      "SubstanceName": "OXALIPLATIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
      "Status": "Active",
      "LastUpdate": "2025-08-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140516",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor., 2 treatment of advanced colorectal cancer.",
      "Description": "Oxaliplatin is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1R,2R)-1,2-cyclohexanediamine-N,N′] [oxalato(2-)-O,O′] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol. Oxaliplatin injection, USP for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin as a clear, colorless, sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an inactive ingredient."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"67457-217-20","ProprietaryName":"Methadone Hydrochloride","NonProprietaryName":"Methadone Hydrochloride"},{"NDCCode":"31722-217-31","ProprietaryName":"Lidocaine Hydrochloride","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"47682-217-71","ProprietaryName":"Medique Guaicon Dms","NonProprietaryName":"Guaifenesin, Dextromethorphan Hbr"},{"NDCCode":"47993-217-02","ProprietaryName":"Hand Sanitizer","NonProprietaryName":"Hand Sanitizer"},{"NDCCode":"50563-217-01","ProprietaryName":"Body Prescriptions Vitamin C Travel Pack Antibacterial Hand Wipes","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"51079-217-20","ProprietaryName":"Metronidazole","NonProprietaryName":"Metronidazole"},{"NDCCode":"53217-217-20","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"58602-217-20","ProprietaryName":"Aurophen Pain Away Plus Sleep Aid","NonProprietaryName":"Acetaminophen, Diphenhydramine Hydrochloride"},{"NDCCode":"60793-217-20","ProprietaryName":"Thrombin-jmi","NonProprietaryName":"Thrombin, Topical (bovine)"},{"NDCCode":"60793-217-21","ProprietaryName":"Thrombin-jmi","NonProprietaryName":"Thrombin, Topical (bovine)"},{"NDCCode":"60793-217-22","ProprietaryName":"Thrombin-jmi","NonProprietaryName":"Thrombin, Topical (bovine)"},{"NDCCode":"63868-217-20","ProprietaryName":"Regular Strength Pain Relief","NonProprietaryName":"Acetaminophen"},{"NDCCode":"64220-217-07","NonProprietaryName":"Oseltamivir Phosphate"},{"NDCCode":"67544-217-20","ProprietaryName":"Temazepam","NonProprietaryName":"Temazepam"},{"NDCCode":"69842-217-15","ProprietaryName":"Nicotine Polacrilex","NonProprietaryName":"Nicotine Polacrilex Gum"},{"NDCCode":"72603-217-25","ProprietaryName":"Ropivacaine Hydrochloride","NonProprietaryName":"Ropivacaine Hydrochloride"},{"NDCCode":"76138-217-06","ProprietaryName":"5299 Sunscreen","NonProprietaryName":"Octocrylene, Titanium Dioxide, Octisalate"},{"NDCCode":"76420-217-20","ProprietaryName":"Ondansetron","NonProprietaryName":"Ondansetron"},{"NDCCode":"67457-181-20","ProprietaryName":"Ketamine Hydrochloride","NonProprietaryName":"Ketamine Hydrochloride"},{"NDCCode":"67457-183-20","ProprietaryName":"Etomidate","NonProprietaryName":"Etomidate"},{"NDCCode":"67457-222-20","ProprietaryName":"Vancomycin Hydrochloride","NonProprietaryName":"Vancomycin Hydrochloride"},{"NDCCode":"67457-280-20","ProprietaryName":"Labetalol Hydrochloride","NonProprietaryName":"Labetalol"},{"NDCCode":"67457-316-25","ProprietaryName":"Decitabine","NonProprietaryName":"Decitabine"},{"NDCCode":"67457-326-05","ProprietaryName":"Bendamustine Hydrochloride","NonProprietaryName":"Bendamustine Hydrochloride"},{"NDCCode":"67457-340-01","ProprietaryName":"Vancomycin Hydrochloride","NonProprietaryName":"Vancomycin Hydrochloride"},{"NDCCode":"67457-386-81","ProprietaryName":"Mycophenolate Mofetil","NonProprietaryName":"Mycophenolate Mofetil"},{"NDCCode":"67457-397-99","ProprietaryName":"Ranitidine","NonProprietaryName":"Ranitidine"},{"NDCCode":"67457-429-20","ProprietaryName":"Ifosfamide","NonProprietaryName":"Ifosfamide"},{"NDCCode":"67457-441-20","ProprietaryName":"Ondansetron Hydrochloride","NonProprietaryName":"Ondansetron"},{"NDCCode":"67457-442-20","ProprietaryName":"Oxaliplatin","NonProprietaryName":"Oxaliplatin"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>67457-217-20</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20)  / 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>67457-0217-20</NDC11Code>
    <ProductNDC>67457-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methadone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20100517</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021624</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1.Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration (see WARNINGS), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. 2.For use in temporary treatment of opioid dependence in patients unable to take oral medication.Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.</IndicationAndUsage>
    <Description>Methadone Hydrochloride Injection USP, 10 mg/mL is an opioid analgesic for parenteral use (intravenous, intramuscular or subcutaneous use). Methadone Hydrochloride Injection USP, 10 mg/mL contains methadone hydrochloride as the active pharmaceutical ingredient. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. Methadone hydrochloride has the following structural formula. Methadone Hydrochloride Injection is a sterile injectable solution available in 20 mL multiple-dose vials. Each mL of the Methadone Hydrochloride Injection contains: 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone free base), 5 mg of chlorobutanol, as a preservative, 9 mg of sodium chloride, as tonicity agent, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. The pH of the sterile injectable solution is between 3.0 to 6.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-217-31</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (31722-217-31)  / 20 mL in 1 VIAL, MULTI-DOSE (31722-217-20) </PackageDescription>
    <NDC11Code>31722-0217-31</NDC11Code>
    <ProductNDC>31722-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20211108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214336</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
    <Description>Lidocaine hydrochloride injection contains lidocaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride is by injection, for infiltration, nerve block, use. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks.  Lidocaine hydrochloride, is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight of 270.8 g/mol. Lidocaine hydrochloride molecular formula is C 14H 22N 2O  HCl, and has the following structural formula:. Lidocaine hydrochloride injection in multiple dose vials is a sterile, nonpyrogenic, isotonic, clear, colorless solution containing lidocaine hydrochloride and sodium chloride. Each mL contains 1 mg methylparaben as an antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. £ Quantity is equivalent to 10.66 mg/mL Lidocaine Hydrochloride, USP (Monohydrate). μ Quantity is equivalent to 21.33 mg/mL Lidocaine Hydrochloride, USP (Monohydrate).</Description>
  </NDC>
  <NDC>
    <NDCCode>47682-217-71</NDCCode>
    <PackageDescription>20 PACKET in 1 BOX (47682-217-71)  / 10 mL in 1 PACKET</PackageDescription>
    <NDC11Code>47682-0217-71</NDC11Code>
    <ProductNDC>47682-217</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medique Guaicon Dms</ProprietaryName>
    <NonProprietaryName>Guaifenesin, Dextromethorphan Hbr</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110405</StartMarketingDate>
    <EndMarketingDate>20230901</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>UNIFIRST FIRST AID CORPORATION</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
    <StrengthNumber>10; 100</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110405</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230901</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>47993-217-02</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE (47993-217-02) </PackageDescription>
    <NDC11Code>47993-0217-02</NDC11Code>
    <ProductNDC>47993-217</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Hand Sanitizer</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>g/112mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: Reduces bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50563-217-01</NDCCode>
    <PackageDescription>3 PACKET in 1 PACKAGE (50563-217-01)  &gt; 20 SOLUTION in 1 PACKET</PackageDescription>
    <NDC11Code>50563-0217-01</NDC11Code>
    <ProductNDC>50563-217</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Body Prescriptions Vitamin C Travel Pack Antibacterial Hand Wipes</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200612</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>4.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ To decrease bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51079-217-20</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-217-20)  &gt; 1 TABLET in 1 BLISTER PACK (51079-217-01)</PackageDescription>
    <NDC11Code>51079-0217-20</NDC11Code>
    <ProductNDC>51079-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070044</ApplicationNumber>
    <LabelerName>Mylan Institutional Inc.</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-04-13</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>53217-217-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (53217-217-20)</PackageDescription>
    <NDC11Code>53217-0217-20</NDC11Code>
    <ProductNDC>53217-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940930</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064076</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5) , 2 In combination for treatment of  H. pylori infection and duodenal ulcer disease. (1.5)  .</IndicationAndUsage>
    <Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[(R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S  3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&amp;C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>58602-217-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (58602-217-20)  &gt; 237 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>58602-0217-20</NDC11Code>
    <ProductNDC>58602-217</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aurophen Pain Away Plus Sleep Aid</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150505</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Aurohealth LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500; 25</StrengthNumber>
    <StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>60793-217-20</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (60793-217-20)  *  20 mL in 1 VIAL, GLASS (60793-317-01)  *  20 mL in 1 VIAL, GLASS (60793-221-09) </PackageDescription>
    <NDC11Code>60793-0217-20</NDC11Code>
    <ProductNDC>60793-217</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Thrombin-jmi</ProprietaryName>
    <NonProprietaryName>Thrombin, Topical (bovine)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19950224</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102865</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THROMBIN-JMI is a topical bovine thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. In various types of surgeries, solutions of THROMBIN-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.</IndicationAndUsage>
    <Description>THROMBIN-JMI, Thrombin, Topical (Bovine), is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The product contains no preservative. THROMBIN-JMI undergoes multistep chromatographic purification and ultrafiltration. The manufacturing process for THROMBIN-JMI has been further improved by the addition of viral filtration and impurity reduction processes. Analytical studies demonstrate the capability of the current manufacturing process to remove significant amounts of extraneous proteins, and result in a reduction of factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay (&lt;92 ng/mL, when reconstituted as directed). The clinical relevance of these findings is unknown.</Description>
  </NDC>
  <NDC>
    <NDCCode>60793-217-21</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (60793-217-21)  *  20 mL in 1 VIAL, GLASS (60793-317-01)  *  20 mL in 1 VIAL, GLASS (60793-221-09) </PackageDescription>
    <NDC11Code>60793-0217-21</NDC11Code>
    <ProductNDC>60793-217</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Thrombin-jmi</ProprietaryName>
    <NonProprietaryName>Thrombin, Topical (bovine)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19950224</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102865</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THROMBIN-JMI is a topical bovine thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. In various types of surgeries, solutions of THROMBIN-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.</IndicationAndUsage>
    <Description>THROMBIN-JMI, Thrombin, Topical (Bovine), is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The product contains no preservative. THROMBIN-JMI undergoes multistep chromatographic purification and ultrafiltration. The manufacturing process for THROMBIN-JMI has been further improved by the addition of viral filtration and impurity reduction processes. Analytical studies demonstrate the capability of the current manufacturing process to remove significant amounts of extraneous proteins, and result in a reduction of factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay (&lt;92 ng/mL, when reconstituted as directed). The clinical relevance of these findings is unknown.</Description>
  </NDC>
  <NDC>
    <NDCCode>60793-217-22</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (60793-217-22)  *  20 mL in 1 VIAL, GLASS (60793-317-01)  *  20 mL in 1 VIAL, GLASS (60793-221-09) </PackageDescription>
    <NDC11Code>60793-0217-22</NDC11Code>
    <ProductNDC>60793-217</ProductNDC>
    <ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
    <ProprietaryName>Thrombin-jmi</ProprietaryName>
    <NonProprietaryName>Thrombin, Topical (bovine)</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>19950224</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102865</ApplicationNumber>
    <LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-09-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950224</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>THROMBIN-JMI is a topical bovine thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. In various types of surgeries, solutions of THROMBIN-JMI may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.</IndicationAndUsage>
    <Description>THROMBIN-JMI, Thrombin, Topical (Bovine), is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The product contains no preservative. THROMBIN-JMI undergoes multistep chromatographic purification and ultrafiltration. The manufacturing process for THROMBIN-JMI has been further improved by the addition of viral filtration and impurity reduction processes. Analytical studies demonstrate the capability of the current manufacturing process to remove significant amounts of extraneous proteins, and result in a reduction of factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay (&lt;92 ng/mL, when reconstituted as directed). The clinical relevance of these findings is unknown.</Description>
  </NDC>
  <NDC>
    <NDCCode>63868-217-20</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (63868-217-20)  &gt; 20 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
    <NDC11Code>63868-0217-20</NDC11Code>
    <ProductNDC>63868-217</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Regular Strength Pain Relief</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170713</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Chain Drug Marketing Association Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>325</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170713</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves minor aches and pains due to:. headachemuscular achesbackacheminor pain of arthritisthe common coldtoothachepremenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64220-217-07</NDCCode>
    <PackageDescription>20 kg in 1 DRUM (64220-217-07) </PackageDescription>
    <NDC11Code>64220-0217-07</NDC11Code>
    <ProductNDC>64220-217</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20250513</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
    <SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-05-14</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>13-MAY-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>67544-217-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-20) </PackageDescription>
    <NDC11Code>67544-0217-20</NDC11Code>
    <ProductNDC>67544-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Temazepam</ProprietaryName>
    <NonProprietaryName>Temazepam</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121025</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070920</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>TEMAZEPAM</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69842-217-15</NDCCode>
    <PackageDescription>20 BLISTER PACK in 1 CARTON (69842-217-15)  / 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>69842-0217-15</NDC11Code>
    <ProductNDC>69842-217</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nicotine Polacrilex</ProprietaryName>
    <ProprietaryNameSuffix>Coated Ice Mint</ProprietaryNameSuffix>
    <NonProprietaryName>Nicotine Polacrilex Gum</NonProprietaryName>
    <DosageFormName>GUM, CHEWING</DosageFormName>
    <RouteName>BUCCAL</RouteName>
    <StartMarketingDate>20160501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204833</ApplicationNumber>
    <LabelerName>CVS Pharmacy</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72603-217-25</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (72603-217-25)  / 20 mL in 1 VIAL (72603-217-01) </PackageDescription>
    <NDC11Code>72603-0217-25</NDC11Code>
    <ProductNDC>72603-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
    <StartMarketingDate>20240301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212808</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management.Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltrationAcute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
    <Description>Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. C17H26N2OHClH2O M.W. 328.89. At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.0 mg, 5.0 mg, 10 mg of Ropivacaine Hydrochloride (equivalent to 2.1 mg, 5.3 mg, 10.6 mg Ropivacaine Hydrochloride monohydrate), and 8.6 mg, 8.0 mg, 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
  </NDC>
  <NDC>
    <NDCCode>76138-217-06</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE, PLASTIC (76138-217-06) </PackageDescription>
    <NDC11Code>76138-0217-06</NDC11Code>
    <ProductNDC>76138-217</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>5299 Sunscreen</ProprietaryName>
    <NonProprietaryName>Octocrylene, Titanium Dioxide, Octisalate</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180601</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Innovation Specialties</LabelerName>
    <SubstanceName>OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>5; 9; 7</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76420-217-20</NDCCode>
    <PackageDescription>20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-217-20) </PackageDescription>
    <NDC11Code>76420-0217-20</NDC11Code>
    <ProductNDC>76420-217</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron</ProprietaryName>
    <NonProprietaryName>Ondansetron</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100412</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090469</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>ONDANSETRON</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2, 2 initial and repeat courses of moderately emetogenic cancer chemotherapy, 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.</IndicationAndUsage>
    <Description>The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula: The molecular formula is C 18H 19N 3O representing a molecular weight of 293.4 g/mol. Ondansetron is a white to off-white powder. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing. Meets USP Disintegration Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-181-20</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (67457-181-20)  / 20 mL in 1 VIAL (67457-181-00) </PackageDescription>
    <NDC11Code>67457-0181-20</NDC11Code>
    <ProductNDC>67457-181</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20130604</StartMarketingDate>
    <EndMarketingDate>20231031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076092</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130604</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-183-20</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (67457-183-20)  &gt; 20 mL in 1 VIAL, SINGLE-USE (67457-183-99)</PackageDescription>
    <NDC11Code>67457-0183-20</NDC11Code>
    <ProductNDC>67457-183</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Etomidate</ProprietaryName>
    <NonProprietaryName>Etomidate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20130426</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091297</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>ETOMIDATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE],General Anesthetic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-05-10</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67457-222-20</NDCCode>
    <PackageDescription>10 VIAL, GLASS in 1 CARTON (67457-222-20)  &gt; 20 mL in 1 VIAL, GLASS (67457-222-00)</PackageDescription>
    <NDC11Code>67457-0222-20</NDC11Code>
    <ProductNDC>67457-222</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20080630</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065401</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC],Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-01-11</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67457-280-20</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (67457-280-20)  &gt; 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>67457-0280-20</NDC11Code>
    <ProductNDC>67457-280</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Labetalol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20120629</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090699</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-07-25</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>67457-316-25</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (67457-316-25)  &gt; 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>67457-0316-25</NDC11Code>
    <ProductNDC>67457-316</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Decitabine</ProprietaryName>
    <NonProprietaryName>Decitabine</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20181010</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204607</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>DECITABINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.</IndicationAndUsage>
    <Description>Decitabine is nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C 8H 12N 4O 4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1 H)-one and it has the following structural formula:. Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for injection (decitabine), for a intravenous use, is a sterile white to almost white, lyophilized powder supplied in a clear colorless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and /or hydrochloric acid are used for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-326-05</NDCCode>
    <PackageDescription>20 mL in 1 VIAL, SINGLE-DOSE (67457-326-05) </PackageDescription>
    <NDC11Code>67457-0326-05</NDC11Code>
    <ProductNDC>67457-326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bendamustine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Bendamustine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180426</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204104</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>BENDAMUSTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-02-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-340-01</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (67457-340-01)  / 20 mL in 1 VIAL (67457-340-00) </PackageDescription>
    <NDC11Code>67457-0340-01</NDC11Code>
    <ProductNDC>67457-340</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20131205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065397</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/20mL</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis.  Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
    <Description>Vancomycin Hydrochloride for Injection, USP is an off white to light tan colored lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of base is equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection, USP to a concentration of 50 mg/mL, it forms a clear, colorless or light to dark tan solution with the pH of the solution is between 2.5 and 4.5. It may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30, 32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m] [10,2,16]benzoxadiazacyclotetracosine -26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24  HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-386-81</NDCCode>
    <PackageDescription>4 VIAL in 1 CARTON (67457-386-81)  / 20 mL in 1 VIAL (67457-386-00) </PackageDescription>
    <NDC11Code>67457-0386-81</NDC11Code>
    <ProductNDC>67457-386</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
    <NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20210126</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203859</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/20mL</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
    <Description>Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula. MMF is a white or almost white, crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.7 to 4.1. Mycophenolate mofetil for injection, USP is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4methyl-4-hexenoate hydrochloride. It has an empirical formula of C23H31NO7 HCl and a molecular weight of 469.96. Mycophenolate mofetil for injection, USP is available as a sterile white to off-white lyophilized powder, plug or cake in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil, USP equivalent to 542 mg of mycophenolate mofetil hydrochloride. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of mycophenolate mofetil for injection to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6)].</Description>
  </NDC>
  <NDC>
    <NDCCode>67457-397-99</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (67457-397-99)  &gt; 2 mL in 1 VIAL (67457-397-20) </PackageDescription>
    <NDC11Code>67457-0397-99</NDC11Code>
    <ProductNDC>67457-397</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine</ProprietaryName>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180817</StartMarketingDate>
    <EndMarketingDate>20210630</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA079076</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180817</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210630</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-429-20</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (67457-429-20)  &gt; 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>67457-0429-20</NDC11Code>
    <ProductNDC>67457-429</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ifosfamide</ProprietaryName>
    <NonProprietaryName>Ifosfamide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20121127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201689</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>IFOSFAMIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-20</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>67457-441-20</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (67457-441-20)  &gt; 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>67457-0441-20</NDC11Code>
    <ProductNDC>67457-441</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ondansetron</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20141229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090648</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67457-442-20</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (67457-442-20)  / 20 mL in 1 VIAL</PackageDescription>
    <NDC11Code>67457-0442-20</NDC11Code>
    <ProductNDC>67457-442</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxaliplatin</ProprietaryName>
    <NonProprietaryName>Oxaliplatin</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20140516</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091358</ApplicationNumber>
    <LabelerName>Mylan Institutional LLC</LabelerName>
    <SubstanceName>OXALIPLATIN</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140516</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor., 2 treatment of advanced colorectal cancer.</IndicationAndUsage>
    <Description>Oxaliplatin is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1R,2R)-1,2-cyclohexanediamine-N,N′] [oxalato(2-)-O,O′] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol. Oxaliplatin injection, USP for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin as a clear, colorless, sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an inactive ingredient.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>67457-217-20</NDCCode><ProprietaryName>Methadone Hydrochloride</ProprietaryName><NonProprietaryName>Methadone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>31722-217-31</NDCCode><ProprietaryName>Lidocaine Hydrochloride</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>47682-217-71</NDCCode><ProprietaryName>Medique Guaicon Dms</ProprietaryName><NonProprietaryName>Guaifenesin, Dextromethorphan Hbr</NonProprietaryName></NDC><NDC><NDCCode>47993-217-02</NDCCode><ProprietaryName>Hand Sanitizer</ProprietaryName><NonProprietaryName>Hand Sanitizer</NonProprietaryName></NDC><NDC><NDCCode>50563-217-01</NDCCode><ProprietaryName>Body Prescriptions Vitamin C Travel Pack Antibacterial Hand Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>51079-217-20</NDCCode><ProprietaryName>Metronidazole</ProprietaryName><NonProprietaryName>Metronidazole</NonProprietaryName></NDC><NDC><NDCCode>53217-217-20</NDCCode><ProprietaryName>Amoxicillin</ProprietaryName><NonProprietaryName>Amoxicillin</NonProprietaryName></NDC><NDC><NDCCode>58602-217-20</NDCCode><ProprietaryName>Aurophen Pain Away Plus Sleep Aid</ProprietaryName><NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>60793-217-20</NDCCode><ProprietaryName>Thrombin-jmi</ProprietaryName><NonProprietaryName>Thrombin, Topical (bovine)</NonProprietaryName></NDC><NDC><NDCCode>60793-217-21</NDCCode><ProprietaryName>Thrombin-jmi</ProprietaryName><NonProprietaryName>Thrombin, Topical (bovine)</NonProprietaryName></NDC><NDC><NDCCode>60793-217-22</NDCCode><ProprietaryName>Thrombin-jmi</ProprietaryName><NonProprietaryName>Thrombin, Topical (bovine)</NonProprietaryName></NDC><NDC><NDCCode>63868-217-20</NDCCode><ProprietaryName>Regular Strength Pain Relief</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>64220-217-07</NDCCode><NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName></NDC><NDC><NDCCode>67544-217-20</NDCCode><ProprietaryName>Temazepam</ProprietaryName><NonProprietaryName>Temazepam</NonProprietaryName></NDC><NDC><NDCCode>69842-217-15</NDCCode><ProprietaryName>Nicotine Polacrilex</ProprietaryName><NonProprietaryName>Nicotine Polacrilex Gum</NonProprietaryName></NDC><NDC><NDCCode>72603-217-25</NDCCode><ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76138-217-06</NDCCode><ProprietaryName>5299 Sunscreen</ProprietaryName><NonProprietaryName>Octocrylene, Titanium Dioxide, Octisalate</NonProprietaryName></NDC><NDC><NDCCode>76420-217-20</NDCCode><ProprietaryName>Ondansetron</ProprietaryName><NonProprietaryName>Ondansetron</NonProprietaryName></NDC><NDC><NDCCode>67457-181-20</NDCCode><ProprietaryName>Ketamine Hydrochloride</ProprietaryName><NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67457-183-20</NDCCode><ProprietaryName>Etomidate</ProprietaryName><NonProprietaryName>Etomidate</NonProprietaryName></NDC><NDC><NDCCode>67457-222-20</NDCCode><ProprietaryName>Vancomycin Hydrochloride</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67457-280-20</NDCCode><ProprietaryName>Labetalol Hydrochloride</ProprietaryName><NonProprietaryName>Labetalol</NonProprietaryName></NDC><NDC><NDCCode>67457-316-25</NDCCode><ProprietaryName>Decitabine</ProprietaryName><NonProprietaryName>Decitabine</NonProprietaryName></NDC><NDC><NDCCode>67457-326-05</NDCCode><ProprietaryName>Bendamustine Hydrochloride</ProprietaryName><NonProprietaryName>Bendamustine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67457-340-01</NDCCode><ProprietaryName>Vancomycin Hydrochloride</ProprietaryName><NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67457-386-81</NDCCode><ProprietaryName>Mycophenolate Mofetil</ProprietaryName><NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName></NDC><NDC><NDCCode>67457-397-99</NDCCode><ProprietaryName>Ranitidine</ProprietaryName><NonProprietaryName>Ranitidine</NonProprietaryName></NDC><NDC><NDCCode>67457-429-20</NDCCode><ProprietaryName>Ifosfamide</ProprietaryName><NonProprietaryName>Ifosfamide</NonProprietaryName></NDC><NDC><NDCCode>67457-441-20</NDCCode><ProprietaryName>Ondansetron Hydrochloride</ProprietaryName><NonProprietaryName>Ondansetron</NonProprietaryName></NDC><NDC><NDCCode>67457-442-20</NDCCode><ProprietaryName>Oxaliplatin</ProprietaryName><NonProprietaryName>Oxaliplatin</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",
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      "PracticeLocationAddressPostalCode": "32810-3002",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "407-905-8827",
      "PracticeLocationAddressFaxNumber": "407-645-4587",
      "EnumerationDate": "02/28/2006",
      "LastUpdateDate": "07/28/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "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",
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}
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