{
"NDC": [
{
"NDCCode": "51927-3178-0",
"PackageDescription": "1 kg in 1 CONTAINER (51927-3178-0)",
"NDC11Code": "51927-3178-00",
"ProductNDC": "51927-3178",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tranilast",
"DosageFormName": "POWDER",
"StartMarketingDate": "20020719",
"EndMarketingDate": "20201130",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Professional Compounding Centers of America dba PCCA",
"SubstanceName": "TRANILAST",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04"
},
{
"NDCCode": "50090-3178-0",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (50090-3178-0) ",
"NDC11Code": "50090-3178-00",
"ProductNDC": "50090-3178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171106",
"SamplePackage": "N"
},
{
"NDCCode": "63629-3178-0",
"PackageDescription": "56 TABLET in 1 BOTTLE (63629-3178-0)",
"NDC11Code": "63629-3178-00",
"ProductNDC": "63629-3178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040748",
"LabelerName": "bryant ranch prepack",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "500; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2015-03-27"
},
{
"NDCCode": "68071-3178-0",
"PackageDescription": "200 TABLET in 1 BOTTLE (68071-3178-0) ",
"NDC11Code": "68071-3178-00",
"ProductNDC": "68071-3178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260611",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "70518-3178-0",
"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (70518-3178-0) ",
"NDC11Code": "70518-3178-00",
"ProductNDC": "70518-3178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091625",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210802",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74 to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide."
},
{
"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": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"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": "Deprecated",
"LastUpdate": "2026-10-01",
"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",
"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": "0404-9896-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9896-20) / 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00404-9896-20",
"ProductNDC": "0404-9896",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20220112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089646",
"LabelerName": "Henry Schein, Inc.",
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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, 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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"LabelerName": "Hospira, 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]",
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"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20050916",
"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": "0409-3178-02",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-3178-02) / 30 mL in 1 VIAL, MULTI-DOSE (0409-3178-17) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Hospira, 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": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050927",
"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": "0409-3178-03",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-3178-03) / 50 mL in 1 VIAL, MULTI-DOSE (0409-3178-18) ",
"NDC11Code": "00409-3178-03",
"ProductNDC": "0409-3178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20050916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Hospira, 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": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050919",
"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": "0409-3181-01",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (0409-3181-01) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-3181-11) ",
"NDC11Code": "00409-3181-01",
"ProductNDC": "0409-3181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20050131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089645",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "15; 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": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050131",
"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": "0409-3182-01",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-01) / 20 mL in 1 VIAL, MULTI-DOSE (0409-3182-11) ",
"NDC11Code": "00409-3182-01",
"ProductNDC": "0409-3182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20050623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089646",
"LabelerName": "Hospira, 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": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050915",
"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": "0409-3182-02",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-02) / 30 mL in 1 VIAL, MULTI-DOSE (0409-3182-21) ",
"NDC11Code": "00409-3182-02",
"ProductNDC": "0409-3182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20050623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089646",
"LabelerName": "Hospira, 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": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20051229",
"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": "0409-3182-03",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-03) / 50 mL in 1 VIAL, MULTI-DOSE (0409-3182-31) ",
"NDC11Code": "00409-3182-03",
"ProductNDC": "0409-3182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION; PERINEURAL",
"StartMarketingDate": "20050623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089646",
"LabelerName": "Hospira, 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": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050623",
"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": "0409-3183-01",
"PackageDescription": "5 VIAL, SINGLE-DOSE in 1 CARTON (0409-3183-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-3183-11) ",
"NDC11Code": "00409-3183-01",
"ProductNDC": "0409-3183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20050706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089651",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "20; 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": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050706",
"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": "36987-3178-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-3178-1)",
"NDC11Code": "36987-3178-01",
"ProductNDC": "36987-3178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yellow Dock",
"NonProprietaryName": "Yellow Dock",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "RUMEX CRISPUS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"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": "36987-3178-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-3178-2)",
"NDC11Code": "36987-3178-02",
"ProductNDC": "36987-3178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yellow Dock",
"NonProprietaryName": "Yellow Dock",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "RUMEX CRISPUS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"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."
}
]
}
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<PackageDescription>1 kg in 1 CONTAINER (51927-3178-0)</PackageDescription>
<NDC11Code>51927-3178-00</NDC11Code>
<ProductNDC>51927-3178</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tranilast</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20020719</StartMarketingDate>
<EndMarketingDate>20201130</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Professional Compounding Centers of America dba PCCA</LabelerName>
<SubstanceName>TRANILAST</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
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<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (50090-3178-0) </PackageDescription>
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<ProductNDC>50090-3178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>56 TABLET in 1 BOTTLE (63629-3178-0)</PackageDescription>
<NDC11Code>63629-3178-00</NDC11Code>
<ProductNDC>63629-3178</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>20090801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040748</ApplicationNumber>
<LabelerName>bryant ranch prepack</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>500; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-03-27</LastUpdate>
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<NDC>
<NDCCode>68071-3178-0</NDCCode>
<PackageDescription>200 TABLET in 1 BOTTLE (68071-3178-0) </PackageDescription>
<NDC11Code>68071-3178-00</NDC11Code>
<ProductNDC>68071-3178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
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<NDC>
<NDCCode>70518-3178-0</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BLISTER PACK (70518-3178-0) </PackageDescription>
<NDC11Code>70518-3178-00</NDC11Code>
<ProductNDC>70518-3178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091625</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74 to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
</NDC>
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<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>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>Deprecated</Status>
<LastUpdate>2026-10-01</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>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION</RouteName>
<StartMarketingDate>20220112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089644</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE; LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>ug/mL; mg/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>Deprecated</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220112</StartMarketingDatePackage>
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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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<StartMarketingDatePackage>20051229</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>
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<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (0409-3182-03) / 50 mL in 1 VIAL, MULTI-DOSE (0409-3182-31) </PackageDescription>
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<RouteName>INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20050623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089646</ApplicationNumber>
<LabelerName>Hospira, 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>
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<LastUpdate>2026-09-29</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050623</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>0409-3183-01</NDCCode>
<PackageDescription>5 VIAL, SINGLE-DOSE in 1 CARTON (0409-3183-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-3183-11) </PackageDescription>
<NDC11Code>00409-3183-01</NDC11Code>
<ProductNDC>0409-3183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20050706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089651</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<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>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050706</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>36987-3178-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-3178-1)</PackageDescription>
<NDC11Code>36987-3178-01</NDC11Code>
<ProductNDC>36987-3178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yellow Dock</ProprietaryName>
<NonProprietaryName>Yellow 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>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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>36987-3178-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-3178-2)</PackageDescription>
<NDC11Code>36987-3178-02</NDC11Code>
<ProductNDC>36987-3178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yellow Dock</ProprietaryName>
<NonProprietaryName>Yellow 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>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<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>
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