RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "72476-005-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-005-86) ",
      "NDC11Code": "72476-0005-86",
      "ProductNDC": "72476-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anticavity",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050912",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "ADUSA Distribution, LLC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20050912",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "65162-005-86",
      "PackageDescription": "1 BOTTLE in 1 CARTON (65162-005-86)  / 118 mL in 1 BOTTLE",
      "NDC11Code": "65162-0005-86",
      "ProductNDC": "65162-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cetirizine Hydrochloride",
      "NonProprietaryName": "Cetirizine",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090765",
      "LabelerName": "Amneal Pharmaceuticals LLC",
      "SubstanceName": "CETIRIZINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20091007",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose and throat."
    },
    {
      "NDCCode": "72476-072-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-072-86) ",
      "NDC11Code": "72476-0072-86",
      "ProductNDC": "72476-072",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antiseptic Mouthrinse",
      "NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100418",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "ADUSA Distribution, LLC",
      "SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
      "StrengthNumber": ".92; .42; .6; .64",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20100418",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps control plaque that leads to gingivitis."
    },
    {
      "NDCCode": "72476-153-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-153-86) ",
      "NDC11Code": "72476-0153-86",
      "ProductNDC": "72476-153",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Everyday Clean Dandruff",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19950215",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Retail Business Services, LLC",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "19950215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent recurrence or flaking and itching associated with dandruff."
    },
    {
      "NDCCode": "72476-311-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-311-86) ",
      "NDC11Code": "72476-0311-86",
      "ProductNDC": "72476-311",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dandruff",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19950215",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Retail Business Services, LLC",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231102",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent recurrence or flaking and itching associated with dandruff."
    },
    {
      "NDCCode": "72476-318-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-318-86) ",
      "NDC11Code": "72476-0318-86",
      "ProductNDC": "72476-318",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antiseptic Mouth Rinse",
      "NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "19890313",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "ADUSA Distribution, LLC",
      "SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
      "StrengthNumber": ".92; .42; .6; .64",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19890313",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps control plaque that leads to gingvitis."
    },
    {
      "NDCCode": "72476-434-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-434-86) ",
      "NDC11Code": "72476-0434-86",
      "ProductNDC": "72476-434",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tartar Control Plus",
      "NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130906",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Retail Business Services, LLC",
      "SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
      "StrengthNumber": ".92; .42; .6; .64",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-05-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20130906",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps control plaque that leads to gingivitis."
    },
    {
      "NDCCode": "72476-482-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-482-86) ",
      "NDC11Code": "72476-0482-86",
      "ProductNDC": "72476-482",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol-free Anticavity",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Retail Business Services, LLC",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130203",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "72476-558-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-558-86) ",
      "NDC11Code": "72476-0558-86",
      "ProductNDC": "72476-558",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tartar Control Plus",
      "NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230113",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Retail Business Services, LLC�",
      "SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
      "StrengthNumber": ".92; .42; .6; .64",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230113",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps control plaque that leads to gingivitis."
    },
    {
      "NDCCode": "72476-592-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-592-86) ",
      "NDC11Code": "72476-0592-86",
      "ProductNDC": "72476-592",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Tartar Control Plus",
      "NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130906",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Retail Business Services",
      "SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
      "StrengthNumber": ".92; .42; .6; .64",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20130906",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps control plaque that leads to gingivitis."
    },
    {
      "NDCCode": "72476-664-86",
      "PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (72476-664-86) ",
      "NDC11Code": "72476-0664-86",
      "ProductNDC": "72476-664",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antispetic",
      "NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
      "DosageFormName": "MOUTHWASH",
      "RouteName": "ORAL",
      "StartMarketingDate": "19920915",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "ADUSA Distribution, LLC",
      "SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
      "StrengthNumber": ".92; .42; .6; .64",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19920915",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps control plaque that leads to gingivitis."
    },
    {
      "NDCCode": "72476-971-86",
      "PackageDescription": "1000 mL in 1 BOTTLE (72476-971-86) ",
      "NDC11Code": "72476-0971-86",
      "ProductNDC": "72476-971",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anticavity",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "RINSE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20221208",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Retail Business Services, LLC�",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-02-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20221208",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "0404-9945-50",
      "PackageDescription": "1 VIAL in 1 BAG (0404-9945-50)  / 50 mL in 1 VIAL",
      "NDC11Code": "00404-9945-50",
      "ProductNDC": "0404-9945",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20220112",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "Henry Schein, Inc.",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220112",
      "SamplePackage": "N",
      "IndicationAndUsage": "SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is indicated in adults 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 SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].",
      "Description": "SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE is parenterally by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections are Methyl Paraben Free (MPF). SENSORCAINE/SENSORCAINE WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is parenterally by injection, for infiltration and perineural use. Bupivacaine hydrochloride is a white or almost white, crystalline powder or colorless crystals, soluble in water, freely soluble in alcohol. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Bupivacaine hydrochloride chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. The molecular formula is C18H28N2O·HCl·H2O, with a molecular weight of 342.9 g/mol. Bupivacaine hydrochloride monohydrate has the following chemical structure. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Epinephrine bitartrate is a white to greyish white or light brownish-grey, odorless, crystalline powder, freely soluble in water, slightly soluble in 96% ethanol and methanol, practically insoluble in chloroform, methylene chloride and ether. Epinephrine bitartrate chemical name is (-)-3,4-Dihydroxy- α [(methylamino)methyl] benzyl alcohol (+) tartrate (1:1) salt. The molecular formula is C9H13NO3·C4H6O6, with a molecular weight of 333.29 g/mol. Epinephrine bitartrate has the following chemical structure. SENSORCAINE-MPFin single dose vials is a sterile, isotonic, clear, colorless, and preservative-free solution. Each mL contains 2.64 mg, 5.27 mg, or 7.92 mg of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, and also equivalent to 2.5 mg, 5.0 mg, or 7.5 mg of bupivacaine hydrochloride anhydrous; respectively), 8.0 mg sodium chloride for isotonicity, and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 4.0 and 6.5. SENSORCAINE-MPF WITH EPINEPHRINE 1:200,000(as bitartrate) in single dose vials is a sterile, isotonic, clear, colorless to slightly yellow and preservative-free solution. Each mL contains 2.64 mg, 5.27 mg, or 7.92 mg of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, and also equivalent to 2.5 mg, 5.0 mg or 7.5 mg bupivacaine hydrochloride anhydrous; respectively), 0.0091 mg or 9.09 mcg of epinephrine bitartrate (equivalent to 0.005 mg of epinephrine base), 0.5 mg sodium metabisulfite as an antioxidant, 0.2 mg citric acid (anhydrous) as a stabilizer, 8.0 mg sodium chloride for isotonicity, and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 3.3 to 5.5. SENSORCAINEin multiple dose vials is a sterile, isotonic, clear, colorless solution. Each mL contains 2.64 mg, or 5.27 mg, of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, or 4.44 mg of bupivacaine, and also equivalent to 2.5 mg and 5.0 mg of bupivacaine hydrochloride anhydrous; respectively), 8.0 g sodium chloride for isotonicity, 1 mg of methyl paraben as an antiseptic preservative and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 4.0 and 6.5. SENSORCAINE WITH EPINEPHRINE 1:200,000(as bitartrate) in multiple dose vials is a sterile, isotonic, clear, colorless to slightly yellow solution. Each mL contains 2.64 mg, or 5.27 mg, of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, or 4.44 mg of bupivacaine, and also equivalent to 2.5 mg and 5.0 mg of bupivacaine hydrochloride anhydrous; respectively), 8.0 mg sodium chloride for isotonicity, 0.0091 mg or 9.09 mcg of epinephrine bitartrate (equivalent to 0.005 mg of epinephrine base), 1 mg methylparaben as an antiseptic preservative, 0.5 mg sodium metabisulfite as an antioxidant, 0.2 mg citric acid (anhydrous) as a stabilizer, and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 3.3 to 5.5."
    },
    {
      "NDCCode": "0404-9946-10",
      "PackageDescription": "1 VIAL in 1 BAG (0404-9946-10)  / 10 mL in 1 VIAL",
      "NDC11Code": "00404-9946-10",
      "ProductNDC": "0404-9946",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine Mpf",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20220112",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070553",
      "LabelerName": "Henry Schein, Inc.",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-11-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220112",
      "SamplePackage": "N",
      "IndicationAndUsage": "SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is indicated in adults 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 SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use. Not all blocks are indicated for use with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)].",
      "Description": "SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE is parenterally by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections are Methyl Paraben Free (MPF). SENSORCAINE/SENSORCAINE WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is parenterally by injection, for infiltration and perineural use. Bupivacaine hydrochloride is a white or almost white, crystalline powder or colorless crystals, soluble in water, freely soluble in alcohol. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Bupivacaine hydrochloride chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. The molecular formula is C18H28N2O·HCl·H2O, with a molecular weight of 342.9 g/mol. Bupivacaine hydrochloride monohydrate has the following chemical structure. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Epinephrine bitartrate is a white to greyish white or light brownish-grey, odorless, crystalline powder, freely soluble in water, slightly soluble in 96% ethanol and methanol, practically insoluble in chloroform, methylene chloride and ether. Epinephrine bitartrate chemical name is (-)-3,4-Dihydroxy- α [(methylamino)methyl] benzyl alcohol (+) tartrate (1:1) salt. The molecular formula is C9H13NO3·C4H6O6, with a molecular weight of 333.29 g/mol. Epinephrine bitartrate has the following chemical structure. SENSORCAINE-MPF in single dose vials is a sterile, isotonic, clear, colorless, and preservative-free solution. Each mL contains 2.64 mg, 5.27 mg, or 7.92 mg of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, and also equivalent to 2.5 mg, 5.0 mg, or 7.5 mg of bupivacaine hydrochloride anhydrous; respectively), 8.0 mg sodium chloride for isotonicity, and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 4.0 and 6.5. SENSORCAINE-MPF WITH EPINEPHRINE 1:200,000 (as bitartrate) in single dose vials is a sterile, isotonic, clear, colorless to slightly yellow and preservative-free solution. Each mL contains 2.64 mg, 5.27 mg, or 7.92 mg of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, and also equivalent to 2.5 mg, 5.0 mg or 7.5 mg bupivacaine hydrochloride anhydrous; respectively), 0.0091 mg or 9.09 mcg of epinephrine bitartrate (equivalent to 0.005 mg of epinephrine base), 0.5 mg sodium metabisulfite as an antioxidant, 0.2 mg citric acid (anhydrous) as a stabilizer, 8.0 mg sodium chloride for isotonicity, and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 3.3 to 5.5. SENSORCAINE in multiple dose vials is a sterile, isotonic, clear, colorless solution. Each mL contains 2.64 mg, or 5.27 mg, of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, or 4.44 mg of bupivacaine, and also equivalent to 2.5 mg and 5.0 mg of bupivacaine hydrochloride anhydrous; respectively), 8.0 g sodium chloride for isotonicity, 1 mg of methyl paraben as an antiseptic preservative and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 4.0 and 6.5. SENSORCAINE WITH EPINEPHRINE 1:200,000 (as bitartrate) in multiple dose vials is a sterile, isotonic, clear, colorless to slightly yellow solution. Each mL contains 2.64 mg, or 5.27 mg, of bupivacaine hydrochloride monohydrate (equivalent to 2.22 mg, or 4.44 mg of bupivacaine, and also equivalent to 2.5 mg and 5.0 mg of bupivacaine hydrochloride anhydrous; respectively), 8.0 mg sodium chloride for isotonicity, 0.0091 mg or 9.09 mcg of epinephrine bitartrate (equivalent to 0.005 mg of epinephrine base), 1 mg methylparaben as an antiseptic preservative, 0.5 mg sodium metabisulfite as an antioxidant, 0.2 mg citric acid (anhydrous) as a stabilizer, and sodium hydroxide and/or hydrochloric acid as pH adjusters. The pH of these solutions is adjusted to between 3.3 to 5.5."
    },
    {
      "NDCCode": "0404-9947-50",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9947-50)  / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00404-9947-50",
      "ProductNDC": "0404-9947",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERINEURAL",
      "StartMarketingDate": "20220112",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "Henry Schein, Inc.",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-11-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220112",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3, 4-Dihydroxy-a [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates single dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "0406-8865-53",
      "PackageDescription": ".005 kg in 1 BOTTLE (0406-8865-53) ",
      "NDC11Code": "00406-8865-53",
      "ProductNDC": "0406-8865",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Oxycodone Hydrochloride D",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "19860630",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SpecGx LLC",
      "SubstanceName": "OXYCODONE HYDROCHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "DEASchedule": "CII",
      "Status": "Unfinished",
      "LastUpdate": "2026-09-28",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "30-JUN-86"
    },
    {
      "NDCCode": "51662-1397-1",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (51662-1397-1) ",
      "NDC11Code": "51662-1397-01",
      "ProductNDC": "51662-1397",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine(r) (bupivacaine Hci And Epinephrine)",
      "NonProprietaryName": "Sensorcaine(r) (bupivacaine Hci And Epinephrine)",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20191008",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070967",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "2.5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191008",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE & ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS & USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates s ingle dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE & ADMINISTRATIONDOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "51662-1397-2",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 POUCH (51662-1397-2)  / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "51662-1397-02",
      "ProductNDC": "51662-1397",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine(r) (bupivacaine Hci And Epinephrine)",
      "NonProprietaryName": "Sensorcaine(r) (bupivacaine Hci And Epinephrine)",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20191008",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070967",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "2.5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE & ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS & USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates s ingle dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE & ADMINISTRATIONDOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "51662-1397-3",
      "PackageDescription": "25 POUCH in 1 CASE (51662-1397-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "51662-1397-03",
      "ProductNDC": "51662-1397",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine(r) (bupivacaine Hci And Epinephrine)",
      "NonProprietaryName": "Sensorcaine(r) (bupivacaine Hci And Epinephrine)",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20191008",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070967",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "2.5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE & ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS & USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates s ingle dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE & ADMINISTRATIONDOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "51662-1399-1",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (51662-1399-1) ",
      "NDC11Code": "51662-1399-01",
      "ProductNDC": "51662-1399",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hci And Epinephrine",
      "NonProprietaryName": "Bupivacaine Hci And Epinephrine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERINEURAL",
      "StartMarketingDate": "20191209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070968",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191209",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE & ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine. Close.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS & USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates s ingle dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "51662-1399-2",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 POUCH (51662-1399-2)  / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "51662-1399-02",
      "ProductNDC": "51662-1399",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hci And Epinephrine",
      "NonProprietaryName": "Bupivacaine Hci And Epinephrine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERINEURAL",
      "StartMarketingDate": "20191209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070968",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE & ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine. Close.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS & USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates s ingle dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "51662-1399-3",
      "PackageDescription": "25 POUCH in 1 CASE (51662-1399-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "51662-1399-03",
      "ProductNDC": "51662-1399",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hci And Epinephrine",
      "NonProprietaryName": "Bupivacaine Hci And Epinephrine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERINEURAL",
      "StartMarketingDate": "20191209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070968",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210126",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE & ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine. Close.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS & USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates s ingle dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "51662-1588-3",
      "PackageDescription": "25 POUCH in 1 CASE (51662-1588-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1588-2)  / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "51662-1588-03",
      "ProductNDC": "51662-1588",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hcl",
      "NonProprietaryName": "Bupivacaine Hcl",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERINEURAL",
      "StartMarketingDate": "20220711",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220711",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates s ingle dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "51662-1592-3",
      "PackageDescription": "25 POUCH in 1 CASE (51662-1592-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1592-2)  / 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "51662-1592-03",
      "ProductNDC": "51662-1592",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupivacaine Hcl",
      "NonProprietaryName": "Bupivacaine Hcl",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20220713",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220713",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates s ingle dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "52584-465-57",
      "PackageDescription": "1 VIAL in 1 BAG (52584-465-57)  > 50 mL in 1 VIAL",
      "NDC11Code": "52584-0465-57",
      "ProductNDC": "52584-465",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20111017",
      "EndMarketingDate": "20260131",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "General Injectables & Vaccines, Inc",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20111017",
      "EndMarketingDatePackage": "20260131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, oral surgeryprocedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations areindicated for obstetrical anesthesia (see WARNINGS).Experience with non-obstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75%concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block)(see WARNINGS).The routes of administration and indicated Sensorcaine concentrations are:local infiltration 0.25%peripheral nerve block 0.25%, 0.5%retrobulbar block 0.75%sympathetic block 0.25%lumbar epidural 0.25%, 0.5% and 0.75% (non-obstetrical)caudal 0.25%, 0.5%. epidural test dose (see PRECAUTIONS)(see DOSAGE AND ADMINISTRATION for additional information).Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.Use only the single dose ampules and single dose vials for caudal or epidural anesthesia; the multiple dose vials contain a preservativeand, therefore, should not be used for these procedures.",
      "Description": "Sensorcaine® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without. epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specificuses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2-piperidinecarboxamide, 1-butyl-N-(2, 6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3, 4-Dihydroxy-a [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility. and is protein bound to a greater extent than lidocaine.Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and ischemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino orpiperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates single dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxideand/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mLcontains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citricacid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE ANDADMINISTRATION)."
    },
    {
      "NDCCode": "52584-466-17",
      "PackageDescription": "1 VIAL in 1 BAG (52584-466-17)  > 10 mL in 1 VIAL",
      "NDC11Code": "52584-0466-17",
      "ProductNDC": "52584-466",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine Mpf",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20111026",
      "EndMarketingDate": "20240131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070553",
      "LabelerName": "General Injectables & Vaccines, Inc",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20160914",
      "EndMarketingDatePackage": "20240131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3, 4-Dihydroxy-a [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates single dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "52584-467-57",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (52584-467-57)  > 50 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "52584-0467-57",
      "ProductNDC": "52584-467",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "NonProprietaryName": "Bupivacaine Hydrochloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "PERINEURAL",
      "StartMarketingDate": "20111018",
      "EndMarketingDate": "20260131",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "General Injectables & Vaccines, Inc",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20181107",
      "EndMarketingDatePackage": "20260131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure. Epinephrine is (-)-3, 4-Dihydroxy-a [(methylamino)methyl] benzyl alcohol. It has the following structural formula. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Dosage forms listed as Sensorcaine-MPF indicates single dose solutions that are Methyl Paraben Free (MPF). Sensorcaine-MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid. Sensorcaine-MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Note: The user should have an appreciation and awareness of the formulations and their intended uses (see DOSAGE AND ADMINISTRATION)."
    },
    {
      "NDCCode": "63323-460-37",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-460-37)  / 30 mL in 1 VIAL, SINGLE-DOSE (63323-460-01) ",
      "NDC11Code": "63323-0460-37",
      "ProductNDC": "63323-460",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "ProprietaryNameSuffix": "Mpf",
      "NonProprietaryName": "Bupivacaine Hydrochloride And Epinephrine Bitartrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; RETROBULBAR",
      "StartMarketingDate": "20101119",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "7.5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101119",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure:. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage."
    },
    {
      "NDCCode": "63323-461-57",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-461-57)  / 50 mL in 1 VIAL, MULTI-DOSE (63323-461-01) ",
      "NDC11Code": "63323-0461-57",
      "ProductNDC": "63323-461",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "NonProprietaryName": "Bupivacaine Hydrochloride And Epinephrine Bitartrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INFILTRATION; PERINEURAL",
      "StartMarketingDate": "20101119",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070967",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "2.5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101119",
      "SamplePackage": "N",
      "IndicationAndUsage": "SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is indicated in adults 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 SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
      "Description": "SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE is parenterally by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. SENSORCAINE-MPF / SENSORCAINE-MPF WITH EPINEPHRINE injections are Methyl Paraben Free (MPF). SENSORCAINE/SENSORCAINE WITH EPINEPHRINE injections contains bupivacaine hydrochloride, a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000. The route of administration for SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is parenterally by injection, for infiltration and perineural use. Bupivacaine hydrochloride is a white or almost white, crystalline powder or colorless crystals, soluble in water, freely soluble in alcohol. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Bupivacaine hydrochloride chemical name is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. The molecular formula is C18H28N2O·HCl·H2O, with a molecular weight of 342.9 g/mol. Bupivacaine hydrochloride monohydrate has the following chemical structure:. The pKa of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Epinephrine bitartrate is a white to greyish white or light brownish-grey, odorless, crystalline powder, freely soluble in water, slightly soluble in 96% ethanol and methanol, practically insoluble in chloroform, methylene chloride and ether. Epinephrine bitartrate chemical name is (-)-3,4-Dihydroxy- α [(methylamino)methyl] benzyl alcohol (+) tartrate (1:1) salt. The molecular formula is C9H13NO3·C4H6O6, with a molecular weight of 333.29 g/mol. Epinephrine bitartrate has the following chemical structure:."
    },
    {
      "NDCCode": "63323-462-17",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-462-17)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-462-04) ",
      "NDC11Code": "63323-0462-17",
      "ProductNDC": "63323-462",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sensorcaine",
      "ProprietaryNameSuffix": "Mpf",
      "NonProprietaryName": "Bupivacaine Hydrochloride And Epinephrine Bitartrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20101119",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018304",
      "LabelerName": "Fresenius Kabi USA, LLC",
      "SubstanceName": "BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
      "StrengthNumber": "5; .005",
      "StrengthUnit": "mg/mL; mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20101119",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sensorcaine (bupivacaine HCl) is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS). The routes of administration and indicated Sensorcaine concentrations are:. (See DOSAGE AND ADMINISTRATION for additional information.). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.",
      "Description": "Sensorcaine ® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine. Sensorcaine injections contain bupivacaine HCl which is chemically designated as 2- piperidinecarboxamide, 1-butyl- N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate and has the following structure:. Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl alcohol. It has the following structural formula:. The pK a of bupivacaine (8.1) is similar to that of lidocaine (7.86). However, bupivacaine possesses a greater degree of lipid solubility and is protein bound to a greater extent than lidocaine. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"72476-005-86","ProprietaryName":"Anticavity","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"65162-005-86","ProprietaryName":"Cetirizine Hydrochloride","NonProprietaryName":"Cetirizine"},{"NDCCode":"72476-072-86","ProprietaryName":"Antiseptic Mouthrinse","NonProprietaryName":"Eucalyptol, Menthol, Methyl Salicylate, Thymol"},{"NDCCode":"72476-153-86","ProprietaryName":"Everyday Clean Dandruff","NonProprietaryName":"Pyrithione Zinc"},{"NDCCode":"72476-311-86","ProprietaryName":"Dandruff","NonProprietaryName":"Pyrithione Zinc"},{"NDCCode":"72476-318-86","ProprietaryName":"Antiseptic Mouth Rinse","NonProprietaryName":"Eucalyptol, Menthol, Methyl Salicylate, Thymol"},{"NDCCode":"72476-434-86","ProprietaryName":"Tartar Control Plus","NonProprietaryName":"Eucalyptol, Menthol, Methyl Salicylate, Thymol"},{"NDCCode":"72476-482-86","ProprietaryName":"Alcohol-free Anticavity","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"72476-558-86","ProprietaryName":"Tartar Control Plus","NonProprietaryName":"Eucalyptol, Menthol, Methyl Salicylate, Thymol"},{"NDCCode":"72476-592-86","ProprietaryName":"Tartar Control Plus","NonProprietaryName":"Eucalyptol, Menthol, Methyl Salicylate, Thymol"},{"NDCCode":"72476-664-86","ProprietaryName":"Antispetic","NonProprietaryName":"Eucalyptol, Menthol, Methyl Salicylate, Thymol"},{"NDCCode":"72476-971-86","ProprietaryName":"Anticavity","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"0404-9945-50","ProprietaryName":"Sensorcaine","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"0404-9946-10","ProprietaryName":"Sensorcaine Mpf","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"0404-9947-50","ProprietaryName":"Sensorcaine","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"0406-8865-53","NonProprietaryName":"Oxycodone Hydrochloride D"},{"NDCCode":"51662-1397-1","ProprietaryName":"Sensorcaine(r) (bupivacaine Hci And Epinephrine)","NonProprietaryName":"Sensorcaine(r) (bupivacaine Hci And Epinephrine)"},{"NDCCode":"51662-1397-2","ProprietaryName":"Sensorcaine(r) (bupivacaine Hci And Epinephrine)","NonProprietaryName":"Sensorcaine(r) (bupivacaine Hci And Epinephrine)"},{"NDCCode":"51662-1397-3","ProprietaryName":"Sensorcaine(r) (bupivacaine Hci And Epinephrine)","NonProprietaryName":"Sensorcaine(r) (bupivacaine Hci And Epinephrine)"},{"NDCCode":"51662-1399-1","ProprietaryName":"Bupivacaine Hci And Epinephrine","NonProprietaryName":"Bupivacaine Hci And Epinephrine"},{"NDCCode":"51662-1399-2","ProprietaryName":"Bupivacaine Hci And Epinephrine","NonProprietaryName":"Bupivacaine Hci And Epinephrine"},{"NDCCode":"51662-1399-3","ProprietaryName":"Bupivacaine Hci And Epinephrine","NonProprietaryName":"Bupivacaine Hci And Epinephrine"},{"NDCCode":"51662-1588-3","ProprietaryName":"Bupivacaine Hcl","NonProprietaryName":"Bupivacaine Hcl"},{"NDCCode":"51662-1592-3","ProprietaryName":"Bupivacaine Hcl","NonProprietaryName":"Bupivacaine Hcl"},{"NDCCode":"52584-465-57","ProprietaryName":"Sensorcaine","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"52584-466-17","ProprietaryName":"Sensorcaine Mpf","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"52584-467-57","ProprietaryName":"Sensorcaine","NonProprietaryName":"Bupivacaine Hydrochloride"},{"NDCCode":"63323-460-37","ProprietaryName":"Sensorcaine","NonProprietaryName":"Bupivacaine Hydrochloride And Epinephrine Bitartrate"},{"NDCCode":"63323-461-57","ProprietaryName":"Sensorcaine","NonProprietaryName":"Bupivacaine Hydrochloride And Epinephrine Bitartrate"},{"NDCCode":"63323-462-17","ProprietaryName":"Sensorcaine","NonProprietaryName":"Bupivacaine Hydrochloride And Epinephrine Bitartrate"}]}
                    

<NDCList><NDC><NDCCode>72476-005-86</NDCCode><ProprietaryName>Anticavity</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>65162-005-86</NDCCode><ProprietaryName>Cetirizine Hydrochloride</ProprietaryName><NonProprietaryName>Cetirizine</NonProprietaryName></NDC><NDC><NDCCode>72476-072-86</NDCCode><ProprietaryName>Antiseptic Mouthrinse</ProprietaryName><NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName></NDC><NDC><NDCCode>72476-153-86</NDCCode><ProprietaryName>Everyday Clean Dandruff</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>72476-311-86</NDCCode><ProprietaryName>Dandruff</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>72476-318-86</NDCCode><ProprietaryName>Antiseptic Mouth Rinse</ProprietaryName><NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName></NDC><NDC><NDCCode>72476-434-86</NDCCode><ProprietaryName>Tartar Control Plus</ProprietaryName><NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName></NDC><NDC><NDCCode>72476-482-86</NDCCode><ProprietaryName>Alcohol-free Anticavity</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>72476-558-86</NDCCode><ProprietaryName>Tartar Control Plus</ProprietaryName><NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName></NDC><NDC><NDCCode>72476-592-86</NDCCode><ProprietaryName>Tartar Control Plus</ProprietaryName><NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName></NDC><NDC><NDCCode>72476-664-86</NDCCode><ProprietaryName>Antispetic</ProprietaryName><NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, 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