{
"NDC": [
{
"NDCCode": "66312-181-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-181-16) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0181-16",
"ProductNDC": "66312-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xylocaine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "19850122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088389",
"LabelerName": "Dentsply Pharmaceutical",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; 20",
"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": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090414",
"SamplePackage": "N",
"IndicationAndUsage": "2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). 2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N2O HCI H2O M.W. 288.8. Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s.to adjust pH."
},
{
"NDCCode": "66312-176-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-176-16) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0176-16",
"ProductNDC": "66312-176",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xylocaine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "19850122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088390",
"LabelerName": "Dentsply Pharmaceutical",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"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": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090414",
"SamplePackage": "N",
"IndicationAndUsage": "2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). 2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N2O HCI H2O M.W. 288.8. Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s.to adjust pH."
},
{
"NDCCode": "66312-441-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-441-16) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0441-16",
"ProductNDC": "66312-441",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polocaine",
"NonProprietaryName": "Mepivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "19841010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088387",
"LabelerName": "Dentsply Pharmaceutical",
"SubstanceName": "MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-02-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19841010",
"SamplePackage": "N",
"IndicationAndUsage": "Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.",
"Description": "Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2,' 6' - pipecoloxylidide monohydrochloride with the following structural formula. It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)-α-(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula. It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water. DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED. 3% (30 mg/mL) Polocaine® DENTAL (mepivacaine hydrochloride injection 3% (30 mg/mL)) and 2% (20 mg/mL) Polocaine® DENTAL with Levonordefrin 1:20,000 (mepivacaine hydrochloride 2% (20 mg/mL) with levonordefrin 1:20,000 injection) are sterile solutions for injection."
},
{
"NDCCode": "66312-461-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-461-16) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0461-16",
"ProductNDC": "66312-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polocaine",
"NonProprietaryName": "Mepivacaine Hydrochloride And Levonordefrin",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19841010",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA088388",
"LabelerName": "Dentsply Pharmaceutical",
"SubstanceName": "LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE",
"StrengthNumber": ".05; 20",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-05-28"
},
{
"NDCCode": "66312-540-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-540-16) > 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0540-16",
"ProductNDC": "66312-540",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citanest Forte",
"NonProprietaryName": "Prilocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "19651118",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021383",
"LabelerName": "Dentsply Pharmaceutical Inc.",
"SubstanceName": "PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .005",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "4% Citanest Plain Dental (prilocaine HCl) and 4% Citanest Forte Dental Injections are indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "Citanest Dental (prilocaine HCl) Injection is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent with or without epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition of each available injection is shown in Table 1. Citanest Dental injections contain prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. C 13H 20N 2o ∙ HCl molecular wt = 256.77. Epinephrine is (-) -3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl alcohol and has the following structural formula. C 9H 13NO 3 molecular wt = 183.21. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition of each available injection is shown in Table 1. Note: Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH of Citanest Dental Injections. Filled under nitrogen."
},
{
"NDCCode": "66312-580-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0580-16",
"ProductNDC": "66312-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citanest Forte Dental",
"NonProprietaryName": "Prilocaine Hcl And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20171204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078959",
"LabelerName": "Dentsply Pharmaceutical Inc.",
"SubstanceName": "PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .005",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171204",
"SamplePackage": "N",
"IndicationAndUsage": "Citanest Forte is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "4% Citanest® Forte DENTAL with Epinephrine 1:200,000 (Citanest Forte), Prilocaine HCl 4% (72 mg/1.8 mL) (40 mg/mL) with Epinephrine 1:200,000 Injection, is a sterile, non-pyrogenic isotonic solution that contains a local anesthetic agent with epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1. Citanest Forte contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. and epinephrine, which is (-) -3, 4-Dihydroxy- ∝ -[(methylamino) methyl] benzyl alcohol and has the following structural formula. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition is shown in Table 1."
},
{
"NDCCode": "66312-601-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-601-16) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0601-16",
"ProductNDC": "66312-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articadent",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Dentsply Pharmaceutical",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .01",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "66312-602-16",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-602-16) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0602-16",
"ProductNDC": "66312-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Articadent",
"NonProprietaryName": "Articaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020971",
"LabelerName": "Dentsply Pharmaceutical",
"SubstanceName": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "40; .005",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.",
"Description": "ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide."
},
{
"NDCCode": "46708-181-16",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (46708-181-16) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "46708-0181-16",
"ProductNDC": "46708-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolmitriptan",
"NonProprietaryName": "Zolmitriptan",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205074",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "ZOLMITRIPTAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Zolmitriptan is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use : 1 Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. , 2 Zolmitriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of zolmitriptan have not been established for cluster headache.",
"Description": "Zolmitriptan orally disintegrating tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure. The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to off-white crystalline powder that is freely soluble in N,N-dimethyl formamide, dimethyl sulfoxide and practically insoluble in water. Zolmitriptan orally disintegrating tablets are available as 2.5 mg and 5 mg white to off-white uncoated tablets. The orally disintegrating tablets contain mannitol, microcrystalline cellulose, crospovidone, aspartame [see Warnings and Precautions (5.9)], sodium stearyl fumarate, colloidal silicon dioxide, magnesium stearate, orange flavor, modified food starch and triacetin."
},
{
"NDCCode": "62332-181-16",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (62332-181-16) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "62332-0181-16",
"ProductNDC": "62332-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolmitriptan",
"NonProprietaryName": "Zolmitriptan",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20240110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205074",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "ZOLMITRIPTAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240110",
"SamplePackage": "N",
"IndicationAndUsage": "Zolmitriptan is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use : 1 Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. , 2 Zolmitriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of zolmitriptan have not been established for cluster headache.",
"Description": "Zolmitriptan orally disintegrating tablets, USP contain zolmitriptan, which is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure. The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to off-white crystalline powder that is freely soluble in N,N-dimethyl formamide, dimethyl sulfoxide and practically insoluble in water. Zolmitriptan orally disintegrating tablets are available as 2.5 mg and 5 mg white to off-white uncoated tablets. The orally disintegrating tablets contain mannitol, microcrystalline cellulose, crospovidone, aspartame [see Warnings and Precautions (5.9)], sodium stearyl fumarate, colloidal silicon dioxide, magnesium stearate, orange flavor, modified food starch (corn starch) and triacetin."
},
{
"NDCCode": "67618-181-16",
"PackageDescription": "2 BOTTLE in 1 PACKAGE (67618-181-16) / 237 mL in 1 BOTTLE",
"NDC11Code": "67618-0181-16",
"ProductNDC": "67618-181",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Betadine Gargle",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Atlantis Consumer Healthcare, Inc.",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231228",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of occasional sore throat."
},
{
"NDCCode": "72578-181-16",
"PackageDescription": "90 TABLET in 1 BOTTLE (72578-181-16) ",
"NDC11Code": "72578-0181-16",
"ProductNDC": "72578-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202761",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14).",
"Description": "Doxepin is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, USP equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white or almost white crystalline powder, that is readily soluble in water, in alcohol and in methylene chloride. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet contains the following inactive ingredients: FD&C Blue No.1 aluminium lake, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. In addition 6 mg tablet also contains D&C Yellow No. 10 aluminium lake."
},
{
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"PackageDescription": "473 mL in 1 BOTTLE (72937-181-16) ",
"NDC11Code": "72937-0181-16",
"ProductNDC": "72937-181",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunset Pain Relief Heating",
"ProprietaryNameSuffix": "Camphor And Amino Acids",
"NonProprietaryName": "Methyl Salicylate, Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220909",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "SUNSET NOVELTIES, INC",
"SubstanceName": "MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "9.8; 17.6",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220909",
"SamplePackage": "N",
"IndicationAndUsage": "Aid for temporary local relief of minor pain in muscles or joints."
},
{
"NDCCode": "77368-181-16",
"PackageDescription": "473 mL in 1 BOTTLE (77368-181-16) ",
"NDC11Code": "77368-0181-16",
"ProductNDC": "77368-181",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nurinse",
"NonProprietaryName": "Ethyl Alcohol Lemon",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NuGenTec",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N"
},
{
"NDCCode": "66312-630-14",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (66312-630-14) > 1.8 mL in 1 CARTRIDGE",
"NDC11Code": "66312-0630-14",
"ProductNDC": "66312-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citanest Plain",
"NonProprietaryName": "Prilocaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "19651118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079235",
"LabelerName": "Dentsply Pharmaceutical Inc.",
"SubstanceName": "PRILOCAINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19651118",
"SamplePackage": "N",
"IndicationAndUsage": "4% Citanest Plain Dental Injection, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), (prilocaine HCl Injection, USP), is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1. 4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. C13H20N2O ∙ HCl molecular wt = 256.77. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition is shown in Table 1."
},
{
"NDCCode": "0135-0130-03",
"PackageDescription": "1 CAN in 1 CARTON (0135-0130-03) > 181.4 g in 1 CAN",
"NDC11Code": "00135-0130-03",
"ProductNDC": "0135-0130",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquafresh",
"ProprietaryNameSuffix": "Cavity Protection",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20110128",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "GlaxoSmithKline Consumer Healthcare Holdings (US) LLC",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110128",
"SamplePackage": "N"
},
{
"NDCCode": "0186-0370-20",
"PackageDescription": "1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER",
"NDC11Code": "00186-0370-20",
"ProductNDC": "0186-0370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbicort",
"NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
"DosageFormName": "AEROSOL",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20070529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021929",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "160; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070529",
"SamplePackage": "N",
"IndicationAndUsage": "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
"Description": "SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
},
{
"NDCCode": "0186-0370-28",
"PackageDescription": "1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER",
"NDC11Code": "00186-0370-28",
"ProductNDC": "0186-0370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbicort",
"NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
"DosageFormName": "AEROSOL",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20070529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021929",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "160; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070906",
"SamplePackage": "N",
"IndicationAndUsage": "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
"Description": "SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
},
{
"NDCCode": "0186-0372-20",
"PackageDescription": "1 POUCH in 1 CARTON (0186-0372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER",
"NDC11Code": "00186-0372-20",
"ProductNDC": "0186-0372",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbicort",
"NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
"DosageFormName": "AEROSOL",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20070529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021929",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "80; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070529",
"SamplePackage": "N",
"IndicationAndUsage": "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
"Description": "SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
},
{
"NDCCode": "0186-0372-28",
"PackageDescription": "1 POUCH in 1 CARTON (0186-0372-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER",
"NDC11Code": "00186-0372-28",
"ProductNDC": "0186-0372",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbicort",
"NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
"DosageFormName": "AEROSOL",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20070529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021929",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "80; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070906",
"SamplePackage": "N",
"IndicationAndUsage": "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
"Description": "SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
},
{
"NDCCode": "0310-7370-20",
"PackageDescription": "1 POUCH in 1 CARTON (0310-7370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER",
"NDC11Code": "00310-7370-20",
"ProductNDC": "0310-7370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
"NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
"DosageFormName": "AEROSOL",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200103",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021929",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "160; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200103",
"SamplePackage": "N",
"IndicationAndUsage": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
"Description": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
},
{
"NDCCode": "0310-7372-20",
"PackageDescription": "1 POUCH in 1 CARTON (0310-7372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER",
"NDC11Code": "00310-7372-20",
"ProductNDC": "0310-7372",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
"NonProprietaryName": "Budesonide And Formoterol Fumarate Dihydrate",
"DosageFormName": "AEROSOL",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200103",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021929",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "80; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200103",
"SamplePackage": "N",
"IndicationAndUsage": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
"Description": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
},
{
"NDCCode": "0378-7502-32",
"PackageDescription": "1 POUCH in 1 CARTON (0378-7502-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "00378-7502-32",
"ProductNDC": "0378-7502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breyna",
"NonProprietaryName": "Budesonide And Formoterol Fumarate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211699",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "80; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230731",
"SamplePackage": "N",
"IndicationAndUsage": "BREYNA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
"Description": "BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREYNA also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BREYNA should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BREYNA is budesonide, a corticosteroid designated chemically as (RS)‑11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BREYNA is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
},
{
"NDCCode": "0378-7503-32",
"PackageDescription": "1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER",
"NDC11Code": "00378-7503-32",
"ProductNDC": "0378-7503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Breyna",
"NonProprietaryName": "Budesonide And Formoterol Fumarate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20230731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211699",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUDESONIDE; FORMOTEROL FUMARATE",
"StrengthNumber": "160; 4.5",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230731",
"SamplePackage": "N",
"IndicationAndUsage": "BREYNA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).",
"Description": "BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREYNA also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BREYNA should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BREYNA is budesonide, a corticosteroid designated chemically as (RS)‑11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BREYNA is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group."
},
{
"NDCCode": "15592-3656-1",
"PackageDescription": "181 kg in 1 DRUM (15592-3656-1) ",
"NDC11Code": "15592-3656-01",
"ProductNDC": "15592-3656",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral Oil",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sonneborn, LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JAN-22"
},
{
"NDCCode": "15592-3691-1",
"PackageDescription": "181 kg in 1 DRUM (15592-3691-1) ",
"NDC11Code": "15592-3691-01",
"ProductNDC": "15592-3691",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral Oil",
"DosageFormName": "OIL",
"StartMarketingDate": "20220103",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sonneborn, LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "03-JAN-22"
},
{
"NDCCode": "21130-181-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-181-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "21130-0181-01",
"ProductNDC": "21130-181",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Acid Reducer",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202319",
"LabelerName": "Safeway",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150927",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "21130-181-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-181-03) > 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "21130-0181-03",
"ProductNDC": "21130-181",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Acid Reducer",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202319",
"LabelerName": "Safeway",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150927",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "34666-181-01",
"PackageDescription": "1 TUBE in 1 CARTON (34666-181-01) > 28.35 g in 1 TUBE",
"NDC11Code": "34666-0181-01",
"ProductNDC": "34666-181",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calendulax",
"NonProprietaryName": "Calendula Officinalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nartex Laboratorios Homeopaticos SA DE CV",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "2.973",
"StrengthUnit": "g/28.35g",
"Status": "Deprecated",
"LastUpdate": "2023-01-16",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
},
{
"NDCCode": "34666-181-02",
"PackageDescription": "1 JAR in 1 CARTON (34666-181-02) > 28 g in 1 JAR",
"NDC11Code": "34666-0181-02",
"ProductNDC": "34666-181",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calendulax",
"NonProprietaryName": "Calendula Officinalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nartex Laboratorios Homeopaticos SA DE CV",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "2.973",
"StrengthUnit": "g/28.35g",
"Status": "Deprecated",
"LastUpdate": "2023-01-16",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>66312-181-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-181-16) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0181-16</NDC11Code>
<ProductNDC>66312-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xylocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>19850122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088389</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; 20</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>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). 2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N2O HCI H2O M.W. 288.8. Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s.to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>66312-176-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-176-16) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0176-16</NDC11Code>
<ProductNDC>66312-176</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xylocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>19850122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088390</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</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>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>2% Xylocaine DENTAL Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). 2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N2O HCI H2O M.W. 288.8. Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s.to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>66312-441-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-441-16) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0441-16</NDC11Code>
<ProductNDC>66312-441</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polocaine</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>19841010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088387</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical</LabelerName>
<SubstanceName>MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19841010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.</IndicationAndUsage>
<Description>Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2,' 6' - pipecoloxylidide monohydrochloride with the following structural formula. It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)-α-(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula. It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water. DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED. 3% (30 mg/mL) Polocaine® DENTAL (mepivacaine hydrochloride injection 3% (30 mg/mL)) and 2% (20 mg/mL) Polocaine® DENTAL with Levonordefrin 1:20,000 (mepivacaine hydrochloride 2% (20 mg/mL) with levonordefrin 1:20,000 injection) are sterile solutions for injection.</Description>
</NDC>
<NDC>
<NDCCode>66312-461-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-461-16) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0461-16</NDC11Code>
<ProductNDC>66312-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polocaine</ProprietaryName>
<NonProprietaryName>Mepivacaine Hydrochloride And Levonordefrin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19841010</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA088388</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical</LabelerName>
<SubstanceName>LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-05-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>66312-540-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-540-16) > 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0540-16</NDC11Code>
<ProductNDC>66312-540</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citanest Forte</ProprietaryName>
<NonProprietaryName>Prilocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>19651118</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021383</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical Inc.</LabelerName>
<SubstanceName>PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>4% Citanest Plain Dental (prilocaine HCl) and 4% Citanest Forte Dental Injections are indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>Citanest Dental (prilocaine HCl) Injection is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent with or without epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition of each available injection is shown in Table 1. Citanest Dental injections contain prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. C 13H 20N 2o ∙ HCl molecular wt = 256.77. Epinephrine is (-) -3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl alcohol and has the following structural formula. C 9H 13NO 3 molecular wt = 183.21. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition of each available injection is shown in Table 1. Note: Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH of Citanest Dental Injections. Filled under nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>66312-580-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0580-16</NDC11Code>
<ProductNDC>66312-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citanest Forte Dental</ProprietaryName>
<NonProprietaryName>Prilocaine Hcl And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20171204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078959</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical Inc.</LabelerName>
<SubstanceName>PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citanest Forte is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>4% Citanest® Forte DENTAL with Epinephrine 1:200,000 (Citanest Forte), Prilocaine HCl 4% (72 mg/1.8 mL) (40 mg/mL) with Epinephrine 1:200,000 Injection, is a sterile, non-pyrogenic isotonic solution that contains a local anesthetic agent with epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1. Citanest Forte contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. and epinephrine, which is (-) -3, 4-Dihydroxy- ∝ -[(methylamino) methyl] benzyl alcohol and has the following structural formula. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition is shown in Table 1.</Description>
</NDC>
<NDC>
<NDCCode>66312-601-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-601-16) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0601-16</NDC11Code>
<ProductNDC>66312-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articadent</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>66312-602-16</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-602-16) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0602-16</NDC11Code>
<ProductNDC>66312-602</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Articadent</ProprietaryName>
<NonProprietaryName>Articaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020971</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical</LabelerName>
<SubstanceName>ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>40; .005</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.</IndicationAndUsage>
<Description>ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula. Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8. Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula. ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>46708-181-16</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (46708-181-16) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46708-0181-16</NDC11Code>
<ProductNDC>46708-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolmitriptan</ProprietaryName>
<NonProprietaryName>Zolmitriptan</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205074</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>ZOLMITRIPTAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolmitriptan is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use : 1 Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. , 2 Zolmitriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of zolmitriptan have not been established for cluster headache.</IndicationAndUsage>
<Description>Zolmitriptan orally disintegrating tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure. The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to off-white crystalline powder that is freely soluble in N,N-dimethyl formamide, dimethyl sulfoxide and practically insoluble in water. Zolmitriptan orally disintegrating tablets are available as 2.5 mg and 5 mg white to off-white uncoated tablets. The orally disintegrating tablets contain mannitol, microcrystalline cellulose, crospovidone, aspartame [see Warnings and Precautions (5.9)], sodium stearyl fumarate, colloidal silicon dioxide, magnesium stearate, orange flavor, modified food starch and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>62332-181-16</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (62332-181-16) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62332-0181-16</NDC11Code>
<ProductNDC>62332-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolmitriptan</ProprietaryName>
<NonProprietaryName>Zolmitriptan</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205074</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZOLMITRIPTAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolmitriptan is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use : 1 Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. , 2 Zolmitriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of zolmitriptan have not been established for cluster headache.</IndicationAndUsage>
<Description>Zolmitriptan orally disintegrating tablets, USP contain zolmitriptan, which is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure. The empirical formula is C16H21N3O2, representing a molecular weight of 287.36. Zolmitriptan is a white to off-white crystalline powder that is freely soluble in N,N-dimethyl formamide, dimethyl sulfoxide and practically insoluble in water. Zolmitriptan orally disintegrating tablets are available as 2.5 mg and 5 mg white to off-white uncoated tablets. The orally disintegrating tablets contain mannitol, microcrystalline cellulose, crospovidone, aspartame [see Warnings and Precautions (5.9)], sodium stearyl fumarate, colloidal silicon dioxide, magnesium stearate, orange flavor, modified food starch (corn starch) and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>67618-181-16</NDCCode>
<PackageDescription>2 BOTTLE in 1 PACKAGE (67618-181-16) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>67618-0181-16</NDC11Code>
<ProductNDC>67618-181</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Betadine Gargle</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Atlantis Consumer Healthcare, Inc.</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of occasional sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72578-181-16</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72578-181-16) </PackageDescription>
<NDC11Code>72578-0181-16</NDC11Code>
<ProductNDC>72578-181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
<NonProprietaryName>Doxepin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202761</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14).</IndicationAndUsage>
<Description>Doxepin is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, USP equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride, USP is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white or almost white crystalline powder, that is readily soluble in water, in alcohol and in methylene chloride. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each doxepin tablet contains the following inactive ingredients: FD&C Blue No.1 aluminium lake, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. In addition 6 mg tablet also contains D&C Yellow No. 10 aluminium lake.</Description>
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<NDCCode>72937-181-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (72937-181-16) </PackageDescription>
<NDC11Code>72937-0181-16</NDC11Code>
<ProductNDC>72937-181</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunset Pain Relief Heating</ProprietaryName>
<ProprietaryNameSuffix>Camphor And Amino Acids</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate, Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220909</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>SUNSET NOVELTIES, INC</LabelerName>
<SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>9.8; 17.6</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aid for temporary local relief of minor pain in muscles or joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77368-181-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (77368-181-16) </PackageDescription>
<NDC11Code>77368-0181-16</NDC11Code>
<ProductNDC>77368-181</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nurinse</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol Lemon</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NuGenTec</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66312-630-14</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (66312-630-14) > 1.8 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>66312-0630-14</NDC11Code>
<ProductNDC>66312-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citanest Plain</ProprietaryName>
<NonProprietaryName>Prilocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>19651118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079235</ApplicationNumber>
<LabelerName>Dentsply Pharmaceutical Inc.</LabelerName>
<SubstanceName>PRILOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19651118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>4% Citanest Plain Dental Injection, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), (prilocaine HCl Injection, USP), is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1. 4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula. C13H20N2O ∙ HCl molecular wt = 256.77. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition is shown in Table 1.</Description>
</NDC>
<NDC>
<NDCCode>0135-0130-03</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (0135-0130-03) > 181.4 g in 1 CAN</PackageDescription>
<NDC11Code>00135-0130-03</NDC11Code>
<ProductNDC>0135-0130</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquafresh</ProprietaryName>
<ProprietaryNameSuffix>Cavity Protection</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20110128</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare Holdings (US) LLC</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0186-0370-20</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER</PackageDescription>
<NDC11Code>00186-0370-20</NDC11Code>
<ProductNDC>0186-0370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbicort</ProprietaryName>
<NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>AEROSOL</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20070529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021929</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>160; 4.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).</IndicationAndUsage>
<Description>SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.</Description>
</NDC>
<NDC>
<NDCCode>0186-0370-28</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER</PackageDescription>
<NDC11Code>00186-0370-28</NDC11Code>
<ProductNDC>0186-0370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbicort</ProprietaryName>
<NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>AEROSOL</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20070529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021929</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>160; 4.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).</IndicationAndUsage>
<Description>SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.</Description>
</NDC>
<NDC>
<NDCCode>0186-0372-20</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0186-0372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER</PackageDescription>
<NDC11Code>00186-0372-20</NDC11Code>
<ProductNDC>0186-0372</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbicort</ProprietaryName>
<NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>AEROSOL</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20070529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021929</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>80; 4.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).</IndicationAndUsage>
<Description>SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.</Description>
</NDC>
<NDC>
<NDCCode>0186-0372-28</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0186-0372-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER</PackageDescription>
<NDC11Code>00186-0372-28</NDC11Code>
<ProductNDC>0186-0372</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbicort</ProprietaryName>
<NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>AEROSOL</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20070529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021929</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; FORMOTEROL FUMARATE</SubstanceName>
<StrengthNumber>80; 4.5</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).</IndicationAndUsage>
<Description>SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each SYMBICORT 80/4.5 and SYMBICORT 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing either 60 or 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. SYMBICORT also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. SYMBICORT should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of SYMBICORT is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of SYMBICORT is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.</Description>
</NDC>
<NDC>
<NDCCode>0310-7370-20</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0310-7370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER</PackageDescription>
<NDC11Code>00310-7370-20</NDC11Code>
<ProductNDC>0310-7370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</ProprietaryName>
<NonProprietaryName>Budesonide And Formoterol Fumarate Dihydrate</NonProprietaryName>
<DosageFormName>AEROSOL</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200103</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021929</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BUDESONIDE; FORMOTEROL FUMARATE</SubstanceName>
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<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
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<StartMarketingDatePackage>20200103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).</IndicationAndUsage>
<Description>BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.</Description>
</NDC>
<NDC>
<NDCCode>0310-7372-20</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0310-7372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER</PackageDescription>
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<ProductNDC>0310-7372</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).</IndicationAndUsage>
<Description>BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 and BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is budesonide, a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.</Description>
</NDC>
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<PackageDescription>1 POUCH in 1 CARTON (0378-7502-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
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<IndicationAndUsage>BREYNA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).</IndicationAndUsage>
<Description>BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREYNA also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BREYNA should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BREYNA is budesonide, a corticosteroid designated chemically as (RS)‑11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BREYNA is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.</Description>
</NDC>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
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<IndicationAndUsage>BREYNA is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: 1 Treatment of asthma in patients 6 years of age and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2).</IndicationAndUsage>
<Description>BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16)]. After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREYNA also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BREYNA should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BREYNA is budesonide, a corticosteroid designated chemically as (RS)‑11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. The other active component of BREYNA is formoterol fumarate dihydrate, a selective beta2-agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C42H56N4O14 and its molecular weight is 840.9. Its structural formula is. Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
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<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
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<LastUpdate>2023-01-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<StartMarketingDate>20150417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nartex Laboratorios Homeopaticos SA DE CV</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>2.973</StrengthNumber>
<StrengthUnit>g/28.35g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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