{
"NDC": [
{
"NDCCode": "51004-6625-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-6625-5) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-6625-05",
"ProductNDC": "51004-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20140128",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .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": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140128",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "0268-6625-06",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (0268-6625-06) ",
"NDC11Code": "00268-6625-06",
"ProductNDC": "0268-6625",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Solidago Canadensis Pollen",
"NonProprietaryName": "Goldenrod",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "SOLIDAGO CANADENSIS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2023-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N",
"IndicationAndUsage": "These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response, the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.",
"Description": "Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a buffer. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety. Molds are individwually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline or glycerin, filtered aseptically and after final packaging are tested for sterility and safety."
},
{
"NDCCode": "51004-0053-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-0053-5) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-0053-05",
"ProductNDC": "51004-0053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mepivacaine",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088387",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51004-0102-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-0102-5) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-0102-05",
"ProductNDC": "51004-0102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20151204",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .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": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151204",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "51004-0550-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-0550-5) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-0550-05",
"ProductNDC": "51004-0550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088389",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; .02",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula."
},
{
"NDCCode": "51004-1010-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-1010-5) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-1010-05",
"ProductNDC": "51004-1010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20150622",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .01",
"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": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150622",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "51004-1040-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-1040-5) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-1040-05",
"ProductNDC": "51004-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .01",
"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": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "51004-1051-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-1051-5) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-1051-05",
"ProductNDC": "51004-1051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088390",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; .01",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula."
},
{
"NDCCode": "51004-2010-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-2010-5) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-2010-05",
"ProductNDC": "51004-2010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088390",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; .01",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula."
},
{
"NDCCode": "51004-2020-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-2020-5) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-2020-05",
"ProductNDC": "51004-2020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isocaine",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088387",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51004-2400-1",
"PackageDescription": "5 BAG in 1 BOX (51004-2400-1) > 20 TRAY in 1 BAG > 18 CARTRIDGE in 1 TRAY > 1 mL in 1 CARTRIDGE",
"NDC11Code": "51004-2400-01",
"ProductNDC": "51004-2400",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Epinephrine Injection",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20200108",
"MarketingCategoryName": "EXPORT ONLY",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Unfinished",
"LastUpdate": "2020-01-10",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "51004-6620-5",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-6620-5) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-6620-05",
"ProductNDC": "51004-6620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20150128",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .01",
"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": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150128",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "0404-6625-05",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (0404-6625-05) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "00404-6625-05",
"ProductNDC": "0404-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20140128",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Henry Schein",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .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": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140128",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "0409-6625-14",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-14) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6625-22) ",
"NDC11Code": "00409-6625-14",
"ProductNDC": "0409-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202432",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210301",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Bicarbonate Injection is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.",
"Description": "Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 7.0 to 8.5. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3¯. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O."
},
{
"NDCCode": "0409-6625-35",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-35) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6625-30) ",
"NDC11Code": "00409-6625-35",
"ProductNDC": "0409-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202432",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201015",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Bicarbonate Injection is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.",
"Description": "Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 7.0 to 8.5. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3–. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O."
},
{
"NDCCode": "51004-4175-1",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-4175-1) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-4175-01",
"ProductNDC": "51004-4175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20160404",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .01",
"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": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160404",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "51004-4185-1",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-4185-1) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-4185-01",
"ProductNDC": "51004-4185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articaine",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20160404",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .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": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160404",
"SamplePackage": "N",
"IndicationAndUsage": "Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "0409-6625-02",
"PackageDescription": "25 VIAL in 1 TRAY (0409-6625-02) > 50 mL in 1 VIAL",
"NDC11Code": "00409-6625-02",
"ProductNDC": "0409-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050331",
"EndMarketingDate": "20220301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050331",
"EndMarketingDatePackage": "20220301",
"SamplePackage": "N"
},
{
"NDCCode": "0409-6625-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-25) > 50 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-6625-25",
"ProductNDC": "0409-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140313",
"EndMarketingDate": "20220101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140313",
"EndMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "55154-6625-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-6625-0) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-6625-00",
"ProductNDC": "55154-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040148",
"LabelerName": "Cardinal Health",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-05-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "61699-6625-2",
"PackageDescription": "1 VIAL in 1 BAG (61699-6625-2) > 50 mL in 1 VIAL",
"NDC11Code": "61699-6625-02",
"ProductNDC": "61699-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140703",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "US MedSource, LLC",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis ― e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial ― e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.",
"Description": "Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solutions are offered in concentrations of 4.2%, 5.0%, 7.5% and 8.4%. See table in HOW SUPPLIED section for contents and characteristics. Solution in LVP container has 0.9 mg/mL of edetate disodium, anhydrous added as a stabilizer. The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3¯. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O."
},
{
"NDCCode": "62670-6625-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-6625-0) ",
"NDC11Code": "62670-6625-00",
"ProductNDC": "62670-6625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Bacterial Hand Gel",
"ProprietaryNameSuffix": "Champagne Apple And Honey",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240617",
"EndMarketingDate": "20270617",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "71",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240617",
"EndMarketingDatePackage": "20270617",
"SamplePackage": "N",
"IndicationAndUsage": "Decreases bacteria on hands."
},
{
"NDCCode": "68968-6625-8",
"PackageDescription": "8 POUCH in 1 PACKET (68968-6625-8) / 1 d in 1 POUCH",
"NDC11Code": "68968-6625-08",
"ProductNDC": "68968-6625",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minivelle",
"NonProprietaryName": "Estradiol",
"DosageFormName": "FILM, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20121220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203752",
"LabelerName": "Noven Therapeutics, LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".025",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121220",
"SamplePackage": "N",
"Description": "MINIVELLE (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of MINIVELLE are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 1.65, 2.48, 3.30, 4.95, or 6.6 cm2 and contains 0.41, 0.62, 0.83, 1.24, or 1.65 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39. MINIVELLE is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a polyolefin laminate backing (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "69101-714-01",
"PackageDescription": "1 KIT in 1 CARTON (69101-714-01) * 50 mL in 1 VIAL, MULTI-DOSE (0409-3178-03) * 50 mL in 1 VIAL, MULTI-DOSE (0409-6625-02) * 2 mL in 1 VIAL, SINGLE-DOSE (0409-4050-01)",
"NDC11Code": "69101-0714-01",
"ProductNDC": "69101-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clin-lido-single Use Kit",
"NonProprietaryName": "Clindamycin, Lidocaine Hcl, And Sodium Bicarbonate",
"DosageFormName": "KIT",
"RouteName": "INFILTRATION; INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20150618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062800",
"LabelerName": "Burke Therapeutics, LLC",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "87723-6625-1",
"PackageDescription": "200 g in 1 BOX (87723-6625-1) ",
"NDC11Code": "87723-6625-01",
"ProductNDC": "87723-6625",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kdman",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260525",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Dongguan Youmi Trading Co., Ltd",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260525",
"SamplePackage": "N",
"IndicationAndUsage": "Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, burning, cracking and discomfort which accompany these conditions. Provides fast relief of skin irritation and odor."
},
{
"NDCCode": "51004-0005-3",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-0005-3) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-0005-03",
"ProductNDC": "51004-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mepivacaine",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20150410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088387",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150410",
"SamplePackage": "N",
"IndicationAndUsage": "Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.",
"Description": "Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the following structural formula. It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)--(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula. It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water;. DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED. Mepivacaine hydrochloride injection 3% (30 mg/mL) and Mepivacaine hydrochloride 2% (20 mg/mL) with levonordefrin 1:20,000 injection are sterile solutions for injection."
},
{
"NDCCode": "51004-1095-6",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-1095-6) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-1095-06",
"ProductNDC": "51004-1095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lignospan Standard",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088390",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; .01",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "LIGNOSPAN FORTE and LIGNOSPAN STANDARD are sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula."
},
{
"NDCCode": "51004-1096-7",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-1096-7) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-1096-07",
"ProductNDC": "51004-1096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lignospan Forte",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20111015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088389",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; .02",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51004-1097-8",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-1097-8) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-1097-08",
"ProductNDC": "51004-1097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scandonest L",
"NonProprietaryName": "Mepivacaine Hydrochloride And Levonordefrin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130627",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088388",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN",
"StrengthNumber": "20; .05",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51004-1098-9",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (51004-1098-9) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "51004-1098-09",
"ProductNDC": "51004-1098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scandonest Plain",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088387",
"LabelerName": "Novocol Pharmaceutical of Canada, Inc.",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>51004-6625-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-6625-5) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-6625-05</NDC11Code>
<ProductNDC>51004-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20140128</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0268-6625-06</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (0268-6625-06) </PackageDescription>
<NDC11Code>00268-6625-06</NDC11Code>
<ProductNDC>0268-6625</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Solidago Canadensis Pollen</ProprietaryName>
<NonProprietaryName>Goldenrod</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>SOLIDAGO CANADENSIS POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response, the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.</IndicationAndUsage>
<Description>Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a buffer. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety. Molds are individwually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline or glycerin, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
</NDC>
<NDC>
<NDCCode>51004-0053-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-0053-5) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-0053-05</NDC11Code>
<ProductNDC>51004-0053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mepivacaine</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088387</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51004-0102-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-0102-5) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-0102-05</NDC11Code>
<ProductNDC>51004-0102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20151204</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>51004-0550-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-0550-5) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-0550-05</NDC11Code>
<ProductNDC>51004-0550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088389</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; .02</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>51004-1010-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-1010-5) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-1010-05</NDC11Code>
<ProductNDC>51004-1010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20150622</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>51004-1040-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-1040-5) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-1040-05</NDC11Code>
<ProductNDC>51004-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>51004-1051-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-1051-5) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-1051-05</NDC11Code>
<ProductNDC>51004-1051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088390</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>51004-2010-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-2010-5) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-2010-05</NDC11Code>
<ProductNDC>51004-2010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088390</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>51004-2020-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-2020-5) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-2020-05</NDC11Code>
<ProductNDC>51004-2020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isocaine</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088387</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51004-2400-1</NDCCode>
<PackageDescription>5 BAG in 1 BOX (51004-2400-1) > 20 TRAY in 1 BAG > 18 CARTRIDGE in 1 TRAY > 1 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-2400-01</NDC11Code>
<ProductNDC>51004-2400</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Epinephrine Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20200108</StartMarketingDate>
<MarketingCategoryName>EXPORT ONLY</MarketingCategoryName>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-01-10</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51004-6620-5</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-6620-5) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-6620-05</NDC11Code>
<ProductNDC>51004-6620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20150128</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0404-6625-05</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (0404-6625-05) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00404-6625-05</NDC11Code>
<ProductNDC>0404-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20140128</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Henry Schein</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0409-6625-14</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-14) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6625-22) </PackageDescription>
<NDC11Code>00409-6625-14</NDC11Code>
<ProductNDC>0409-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202432</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Bicarbonate Injection is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
<Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 7.0 to 8.5. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3¯. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.</Description>
</NDC>
<NDC>
<NDCCode>0409-6625-35</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-35) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6625-30) </PackageDescription>
<NDC11Code>00409-6625-35</NDC11Code>
<ProductNDC>0409-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202432</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Bicarbonate Injection is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
<Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 7.0 to 8.5. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3–. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.</Description>
</NDC>
<NDC>
<NDCCode>51004-4175-1</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-4175-1) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-4175-01</NDC11Code>
<ProductNDC>51004-4175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20160404</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>51004-4185-1</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-4185-1) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-4185-01</NDC11Code>
<ProductNDC>51004-4185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articaine</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20160404</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>Articaine HCl and Epinephrine, for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture.Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. Articaine HCl and Epinephrine contains the following inactive ingredients: sodium chloride (1.6 mg/mL) and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0409-6625-02</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (0409-6625-02) > 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>00409-6625-02</NDC11Code>
<ProductNDC>0409-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050331</StartMarketingDate>
<EndMarketingDate>20220301</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050331</StartMarketingDatePackage>
<EndMarketingDatePackage>20220301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-6625-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-25) > 50 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-6625-25</NDC11Code>
<ProductNDC>0409-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140313</StartMarketingDate>
<EndMarketingDate>20220101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140313</StartMarketingDatePackage>
<EndMarketingDatePackage>20220101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-6625-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-6625-0) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-6625-00</NDC11Code>
<ProductNDC>55154-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040148</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-05-30</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61699-6625-2</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (61699-6625-2) > 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>61699-6625-02</NDC11Code>
<ProductNDC>61699-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140703</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>US MedSource, LLC</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis ― e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial ― e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
<Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solutions are offered in concentrations of 4.2%, 5.0%, 7.5% and 8.4%. See table in HOW SUPPLIED section for contents and characteristics. Solution in LVP container has 0.9 mg/mL of edetate disodium, anhydrous added as a stabilizer. The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3¯. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.</Description>
</NDC>
<NDC>
<NDCCode>62670-6625-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-6625-0) </PackageDescription>
<NDC11Code>62670-6625-00</NDC11Code>
<ProductNDC>62670-6625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Bacterial Hand Gel</ProprietaryName>
<ProprietaryNameSuffix>Champagne Apple And Honey</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240617</StartMarketingDate>
<EndMarketingDate>20270617</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>71</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240617</StartMarketingDatePackage>
<EndMarketingDatePackage>20270617</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decreases bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68968-6625-8</NDCCode>
<PackageDescription>8 POUCH in 1 PACKET (68968-6625-8) / 1 d in 1 POUCH</PackageDescription>
<NDC11Code>68968-6625-08</NDC11Code>
<ProductNDC>68968-6625</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minivelle</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>FILM, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20121220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203752</ApplicationNumber>
<LabelerName>Noven Therapeutics, LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>MINIVELLE (estradiol transdermal system) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of MINIVELLE are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 1.65, 2.48, 3.30, 4.95, or 6.6 cm2 and contains 0.41, 0.62, 0.83, 1.24, or 1.65 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39. MINIVELLE is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a polyolefin laminate backing (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>69101-714-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69101-714-01) * 50 mL in 1 VIAL, MULTI-DOSE (0409-3178-03) * 50 mL in 1 VIAL, MULTI-DOSE (0409-6625-02) * 2 mL in 1 VIAL, SINGLE-DOSE (0409-4050-01)</PackageDescription>
<NDC11Code>69101-0714-01</NDC11Code>
<ProductNDC>69101-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clin-lido-single Use Kit</ProprietaryName>
<NonProprietaryName>Clindamycin, Lidocaine Hcl, And Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INFILTRATION; INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20150618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062800</ApplicationNumber>
<LabelerName>Burke Therapeutics, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>87723-6625-1</NDCCode>
<PackageDescription>200 g in 1 BOX (87723-6625-1) </PackageDescription>
<NDC11Code>87723-6625-01</NDC11Code>
<ProductNDC>87723-6625</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kdman</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260525</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Dongguan Youmi Trading Co., Ltd</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, burning, cracking and discomfort which accompany these conditions. Provides fast relief of skin irritation and odor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51004-0005-3</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-0005-3) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-0005-03</NDC11Code>
<ProductNDC>51004-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mepivacaine</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20150410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088387</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.</IndicationAndUsage>
<Description>Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the following structural formula. It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)--(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula. It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water;. DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED. Mepivacaine hydrochloride injection 3% (30 mg/mL) and Mepivacaine hydrochloride 2% (20 mg/mL) with levonordefrin 1:20,000 injection are sterile solutions for injection.</Description>
</NDC>
<NDC>
<NDCCode>51004-1095-6</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-1095-6) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-1095-06</NDC11Code>
<ProductNDC>51004-1095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lignospan Standard</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088390</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>LIGNOSPAN FORTE and LIGNOSPAN STANDARD are sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>51004-1096-7</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-1096-7) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-1096-07</NDC11Code>
<ProductNDC>51004-1096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lignospan Forte</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088389</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; .02</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51004-1097-8</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-1097-8) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-1097-08</NDC11Code>
<ProductNDC>51004-1097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scandonest L</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride And Levonordefrin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130627</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088388</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN</SubstanceName>
<StrengthNumber>20; .05</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51004-1098-9</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (51004-1098-9) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>51004-1098-09</NDC11Code>
<ProductNDC>51004-1098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scandonest Plain</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088387</ApplicationNumber>
<LabelerName>Novocol Pharmaceutical of Canada, Inc.</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>