{
"NDC": [
{
"NDCCode": "11822-3183-3",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (11822-3183-3) ",
"NDC11Code": "11822-3183-03",
"ProductNDC": "11822-3183",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241210",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241210",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent the risk of infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "36987-3183-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-3183-3)",
"NDC11Code": "36987-3183-03",
"ProductNDC": "36987-3183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Curly Dock",
"NonProprietaryName": "Curly Dock",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "RUMEX CRISPUS POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-3183-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-3183-3) ",
"NDC11Code": "37662-3183-03",
"ProductNDC": "37662-3183",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lithium Metallicum",
"NonProprietaryName": "Lithium Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230516",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "LITHIUM",
"StrengthNumber": "100",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230516",
"SamplePackage": "N"
},
{
"NDCCode": "38779-3183-3",
"PackageDescription": "5 g in 1 VIAL (38779-3183-3) ",
"NDC11Code": "38779-3183-03",
"ProductNDC": "38779-3183",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190412",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "MEDISCA Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-01-11",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "12-APR-19"
},
{
"NDCCode": "62991-3183-3",
"PackageDescription": "500 g in 1 JAR (62991-3183-3) ",
"NDC11Code": "62991-3183-03",
"ProductNDC": "62991-3183",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Estradiol Hemihydrate Non Micronized",
"DosageFormName": "POWDER",
"StartMarketingDate": "20221020",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "ESTRADIOL HEMIHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2022-11-03",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20-OCT-22"
},
{
"NDCCode": "68071-3183-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-3183-3)",
"NDC11Code": "68071-3183-03",
"ProductNDC": "68071-3183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203034",
"LabelerName": "NuCarePharmaceuticals, Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0264-3183-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3183-11",
"ProductNDC": "0264-3183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem And Sodium Chloride",
"NonProprietaryName": "Meropenem And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202106",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "500",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .",
"Description": "Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP)."
},
{
"NDCCode": "0404-9788-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9788-20) / 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00404-9788-20",
"ProductNDC": "0404-9788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20250217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089646",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "20; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250217",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "0404-9792-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9792-20) / 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00404-9792-20",
"ProductNDC": "0404-9792",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20250221",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250221",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "0404-9886-50",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9886-50) / 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00404-9886-50",
"ProductNDC": "0404-9886",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20220111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089635",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "5; 5",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220111",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "0404-9891-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-20) / 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00404-9891-20",
"ProductNDC": "0404-9891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20220112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220112",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "0404-9891-30",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-30) / 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00404-9891-30",
"ProductNDC": "0404-9891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20220112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "EPINEPHRINE; LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "ug/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220112",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
},
{
"NDCCode": "0404-9891-50",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-50) / 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00404-9891-50",
"ProductNDC": "0404-9891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20220112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; ug/mL",
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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"Description": "Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula."
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]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>11822-3183-3</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (11822-3183-3) </PackageDescription>
<NDC11Code>11822-3183-03</NDC11Code>
<ProductNDC>11822-3183</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Alcohol</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent the risk of infection in minor cuts, scrapes and burns.</IndicationAndUsage>
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<NDC>
<NDCCode>36987-3183-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-3183-3)</PackageDescription>
<NDC11Code>36987-3183-03</NDC11Code>
<ProductNDC>36987-3183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Curly Dock</ProprietaryName>
<NonProprietaryName>Curly Dock</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>RUMEX CRISPUS POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-3183-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-3183-3) </PackageDescription>
<NDC11Code>37662-3183-03</NDC11Code>
<ProductNDC>37662-3183</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lithium Metallicum</ProprietaryName>
<NonProprietaryName>Lithium Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230516</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>LITHIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>38779-3183-3</NDCCode>
<PackageDescription>5 g in 1 VIAL (38779-3183-3) </PackageDescription>
<NDC11Code>38779-3183-03</NDC11Code>
<ProductNDC>38779-3183</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190412</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>MEDISCA Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-11</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-APR-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62991-3183-3</NDCCode>
<PackageDescription>500 g in 1 JAR (62991-3183-3) </PackageDescription>
<NDC11Code>62991-3183-03</NDC11Code>
<ProductNDC>62991-3183</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Estradiol Hemihydrate Non Micronized</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20221020</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>ESTRADIOL HEMIHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-03</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-OCT-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68071-3183-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-3183-3)</PackageDescription>
<NDC11Code>68071-3183-03</NDC11Code>
<ProductNDC>68071-3183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203034</ApplicationNumber>
<LabelerName>NuCarePharmaceuticals, Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0264-3183-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3183-11</NDC11Code>
<ProductNDC>0264-3183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Meropenem And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202106</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .</IndicationAndUsage>
<Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).</Description>
</NDC>
<NDC>
<NDCCode>0404-9788-20</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (0404-9788-20) / 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00404-9788-20</NDC11Code>
<ProductNDC>0404-9788</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20250217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089646</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>20; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0404-9792-20</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (0404-9792-20) / 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00404-9792-20</NDC11Code>
<ProductNDC>0404-9792</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20250221</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089644</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250221</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0404-9886-50</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (0404-9886-50) / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00404-9886-50</NDC11Code>
<ProductNDC>0404-9886</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20220111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089635</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>5; 5</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0404-9891-20</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-20) / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00404-9891-20</NDC11Code>
<ProductNDC>0404-9891</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION</RouteName>
<StartMarketingDate>20220112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089644</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0404-9891-30</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (0404-9891-30) / 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00404-9891-30</NDC11Code>
<ProductNDC>0404-9891</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
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<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<StrengthNumber>20; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
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<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089651</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
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<StrengthNumber>20; 5</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride and Epinephrine Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Lidocaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows. Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide-type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula. Epinephrine is a vasoconstrictor. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula.</Description>
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