{
"NDC": [
{
"NDCCode": "67296-0485-3",
"PackageDescription": "1 INHALER in 1 CARTON (67296-0485-3) / 8 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "67296-0485-03",
"ProductNDC": "67296-0485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ventolin",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20060609",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020983",
"LabelerName": "Redpharm Drug",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20060609",
"SamplePackage": "N",
"IndicationAndUsage": "VENTOLIN HFA is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2) .",
"Description": "The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure:. Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. VENTOLIN HFA is a blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes."
},
{
"NDCCode": "67296-0485-1",
"PackageDescription": "1 INHALER in 1 CARTON (67296-0485-1) / 18 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "67296-0485-01",
"ProductNDC": "67296-0485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ventolin",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20060609",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020983",
"LabelerName": "Redpharm Drug",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20060609",
"SamplePackage": "N",
"IndicationAndUsage": "VENTOLIN HFA is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2) .",
"Description": "The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure:. Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. VENTOLIN HFA is a blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes."
},
{
"NDCCode": "37662-0485-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-0485-3) ",
"NDC11Code": "37662-0485-03",
"ProductNDC": "37662-0485",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Collinsonia Canadensis",
"NonProprietaryName": "Collinsonia Canadensis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220610",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "COLLINSONIA CANADENSIS ROOT",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220610",
"SamplePackage": "N"
},
{
"NDCCode": "49288-0485-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0485-3)",
"NDC11Code": "49288-0485-03",
"ProductNDC": "49288-0485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "American Sycamore",
"NonProprietaryName": "American Sycamore",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920413",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "PLATANUS OCCIDENTALIS POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "71335-0485-3",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-0485-3) ",
"NDC11Code": "71335-0485-03",
"ProductNDC": "71335-0485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079088",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130620",
"SamplePackage": "N"
},
{
"NDCCode": "0406-0485-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0406-0485-01) ",
"NDC11Code": "00406-0485-01",
"ProductNDC": "0406-0485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040419",
"LabelerName": "SpecGx LLC",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010531",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mgCodeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
},
{
"NDCCode": "0406-0485-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0406-0485-05) ",
"NDC11Code": "00406-0485-05",
"ProductNDC": "0406-0485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040419",
"LabelerName": "SpecGx LLC",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 60",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010531",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mgCodeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
},
{
"NDCCode": "0485-0080-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0080-01) ",
"NDC11Code": "00485-0080-01",
"ProductNDC": "0485-0080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rymed",
"NonProprietaryName": "Dexchlorpheniramine Maleate And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "2; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111115",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passages."
},
{
"NDCCode": "0485-0098-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0485-0098-16) ",
"NDC11Code": "00485-0098-16",
"ProductNDC": "0485-0098",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ed Chlorped Jr",
"NonProprietaryName": "Chlorpheniramine Maleate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110304",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110304",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes."
},
{
"NDCCode": "0485-0171-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0485-0171-16) ",
"NDC11Code": "00485-0171-16",
"ProductNDC": "0485-0171",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ed A-hist Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120911",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "15; 4; 10",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120911",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 cough due to minor throat and bronchial irritation, 6 nasal congestion, 7 reduces swelling of nasal passages."
},
{
"NDCCode": "0485-0202-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0485-0202-16) ",
"NDC11Code": "00485-0202-16",
"ProductNDC": "0485-0202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rynex Pe",
"NonProprietaryName": "Brompheniramine Maleate And Phenylephrine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110307",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "1; 2.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110307",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passage."
},
{
"NDCCode": "0485-0206-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0485-0206-16) ",
"NDC11Code": "00485-0206-16",
"ProductNDC": "0485-0206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rynex Pse",
"NonProprietaryName": "Brompheniramine Maleate And Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110307",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110307",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion 'reduces swelling of nasal passages."
},
{
"NDCCode": "0485-0208-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0485-0208-16) ",
"NDC11Code": "00485-0208-16",
"ProductNDC": "0485-0208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ed Bron Gp",
"NonProprietaryName": "Guaifenesin And Phenylephrine",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "100; 5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passages, 7 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive."
},
{
"NDCCode": "0485-0210-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0210-01) ",
"NDC11Code": "00485-0210-01",
"ProductNDC": "0485-0210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ed-a-hist Pse",
"NonProprietaryName": "Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111008",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE",
"StrengthNumber": "60; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20111008",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passages."
},
{
"NDCCode": "0485-0240-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0240-01) ",
"NDC11Code": "00485-0240-01",
"ProductNDC": "0485-0240",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ed-a-hist Dm",
"NonProprietaryName": "Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141027",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "4; 10; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141027",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 cough due to minor throat and bronchial irritation, 6 nasal congestion, 7 reduces swelling of nasal passages."
},
{
"NDCCode": "0485-0254-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0254-01) ",
"NDC11Code": "00485-0254-01",
"ProductNDC": "0485-0254",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ed A-hist",
"NonProprietaryName": "Chlorpheniramine Maleate And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111008",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "4; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111008",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passages."
},
{
"NDCCode": "0597-0485-20",
"PackageDescription": "2 KIT in 1 CARTON (0597-0485-20) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0480-12) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET",
"NDC11Code": "00597-0485-20",
"ProductNDC": "0597-0485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyltezo",
"NonProprietaryName": "Adalimumab-adbm",
"DosageFormName": "KIT",
"StartMarketingDate": "20240430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761058",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "CYLTEZO is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. CYLTEZO (adalimumab-adbm) injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (CYLTEZO Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of CYLTEZO is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of CYLTEZO contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of CYLTEZO contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of CYLTEZO contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of CYLTEZO contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP."
},
{
"NDCCode": "13668-485-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13668-485-01) ",
"NDC11Code": "13668-0485-01",
"ProductNDC": "13668-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065156",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150402",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride tablets, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.Respiratory tract infections caused by Mycoplasma pneumoniae.Lymphogranuloma venereum caused by Chlamydia trachomatis.Psittacosis (Ornithosis) due to Chlamydophila psittaci.Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by Chlamydia trachomatis.Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis.Relapsing fever due to Borrelia recurrentis.Chancroid caused by Haemophilus ducreyi.Plague due to Yersinia pestis.Tularemia due to Francisella tularensis.Cholera caused by Vibrio cholerae.Campylobacter fetus infections caused by Campylobacter fetus.Brucellosis due to Brucella species (in conjunction with streptomycin).Bartonellosis due to Bartonella bacilliformis.Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli.Klebsiella aerogenes Shigella species.Acinetobacter species.Respiratory tract infections caused by Haemophilus influenzae.Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride tablets, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae.Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.Infections in women caused by Neisseria gonorrhoeae.Syphilis caused by Treponema pallidum subspecies pallidum.Yaws caused by Treponema pallidum subspecies pertenue.Listeriosis due to Listeria monocytogenes.Anthrax due to Bacillus anthracis.Vincent’s infection caused by Fusobacterium fusiforme.Actinomycosis caused by Actinomyces israelii.Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseriameningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets, USP and other antibacterial drugs, minocycline hydrochloride tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7- Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. Minocycline hydrochloride tablets, USP for oral administration, contains minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol 6000, silicified microcrystalline cellulose, stearic acid, and titanium dioxide."
},
{
"NDCCode": "16714-485-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-485-01) ",
"NDC11Code": "16714-0485-01",
"ProductNDC": "16714-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202419",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140602",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium extended-release tablets are indicated for: : 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis (2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release tablets USP 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid. Inactive Ingredients: FD&C Blue #1, FD&C Blue #2, hypromellose, mannitol, polyacrylate dispersion 40 percent, polyethylene glycol, pregelatinised starch (maize), propylene glycol, shellac glaze in ethanol, silicified microcrystalline cellulose, silicon dioxide, titanium dioxide, and triacetin. In addition, 500 mg tablets contain iron oxide black, iron oxide yellow, and polydextrose.Meets USP dissolution test 7."
},
{
"NDCCode": "16714-485-02",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-485-02) ",
"NDC11Code": "16714-0485-02",
"ProductNDC": "16714-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202419",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140602",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium extended-release tablets are indicated for: : 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis (2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release tablets USP 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid. Inactive Ingredients: FD&C Blue #1, FD&C Blue #2, hypromellose, mannitol, polyacrylate dispersion 40 percent, polyethylene glycol, pregelatinised starch (maize), propylene glycol, shellac glaze in ethanol, silicified microcrystalline cellulose, silicon dioxide, titanium dioxide, and triacetin. In addition, 500 mg tablets contain iron oxide black, iron oxide yellow, and polydextrose.Meets USP dissolution test 7."
},
{
"NDCCode": "16729-485-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16729-485-01) ",
"NDC11Code": "16729-0485-01",
"ProductNDC": "16729-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213342",
"LabelerName": "Accord Healthcare, Inc.,",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210126",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. ( 1.1) , 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1) , 3 Treatment of rheumatoid arthritis in adults. ( 1.2) , 4 >Treatment of systemic lupus erythematosus in adults. ( 1.3) , 5 Treatment of chronic discoid lupus erythematosus in adults. ( 1.4) .",
"Description": "Hydroxychloroquine sulfate USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino]ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether. Hydroxychloroquine sulfate tablets, USP 100 mg for oral administration contain 100 mg hydroxychloroquine sulfate (equivalent to 77.5 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 200 mg for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 300 mg for oral administration contain 300 mg hydroxychloroquine sulfate (equivalent to 232.5 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 400 mg for oral administration contain 400 mg hydroxychloroquine sulfate (equivalent to 310 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "16729-485-16",
"PackageDescription": "500 TABLET in 1 BOTTLE (16729-485-16) ",
"NDC11Code": "16729-0485-16",
"ProductNDC": "16729-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213342",
"LabelerName": "Accord Healthcare, Inc.,",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. ( 1.1) , 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1) , 3 Treatment of rheumatoid arthritis in adults. ( 1.2) , 4 >Treatment of systemic lupus erythematosus in adults. ( 1.3) , 5 Treatment of chronic discoid lupus erythematosus in adults. ( 1.4) .",
"Description": "Hydroxychloroquine sulfate USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino]ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether. Hydroxychloroquine sulfate tablets, USP 100 mg for oral administration contain 100 mg hydroxychloroquine sulfate (equivalent to 77.5 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 200 mg for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 300 mg for oral administration contain 300 mg hydroxychloroquine sulfate (equivalent to 232.5 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 400 mg for oral administration contain 400 mg hydroxychloroquine sulfate (equivalent to 310 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "21695-485-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-485-30)",
"NDC11Code": "21695-0485-30",
"ProductNDC": "21695-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072750",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Symptomatic Gastroesophageal Reflux: Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.",
"Description": "Metoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform, practically insoluble in ether. Chemically, it is 4-amino-5-chloro- N-[2-(diethylamino) ethyl]-2-methoxybenzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22CIN3O2HClH2O Molecular Weight: 354.3. Each tablet for oral administration contains metoclopramide hydrochloride, equivalent to either 5 mg or 10 mg metoclopramide. Tablets also contain as inactive ingredients anhydrous lactose, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate and (5 mg only) D&C Yellow #10 and FD&C Blue #1."
},
{
"NDCCode": "21695-485-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (21695-485-90)",
"NDC11Code": "21695-0485-90",
"ProductNDC": "21695-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072750",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Symptomatic Gastroesophageal Reflux: Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.",
"Description": "Metoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform, practically insoluble in ether. Chemically, it is 4-amino-5-chloro- N-[2-(diethylamino) ethyl]-2-methoxybenzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22CIN3O2HClH2O Molecular Weight: 354.3. Each tablet for oral administration contains metoclopramide hydrochloride, equivalent to either 5 mg or 10 mg metoclopramide. Tablets also contain as inactive ingredients anhydrous lactose, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate and (5 mg only) D&C Yellow #10 and FD&C Blue #1."
},
{
"NDCCode": "24208-485-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (24208-485-10) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "24208-0485-10",
"ProductNDC": "24208-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dorzolamide Hcl",
"NonProprietaryName": "Dorzolamide Hcl",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20090625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090143",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090625",
"SamplePackage": "N",
"IndicationAndUsage": "Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Dorzolamide hydrochloride ophthalmic solution, USP is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride USP is described chemically as: (4 S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4 H-thieno[2,3- b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is:. Its empirical formula is C 10H 16N 2O 4S 3∙HCl and its structural formula is:. Dorzolamide hydrochloride USP has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide hydrochloride ophthalmic solution, USP is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride USP. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of dorzolamide hydrochloride ophthalmic solution USP, 2% contains 20 mg dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride USP). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative."
},
{
"NDCCode": "29300-485-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (29300-485-01) ",
"NDC11Code": "29300-0485-01",
"ProductNDC": "29300-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040907",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3, 4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3, 4-dihydro-2H-1, 2, 4- benzothiadiazine-7-sulfonamide 1, 1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate."
},
{
"NDCCode": "29300-485-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (29300-485-10) ",
"NDC11Code": "29300-0485-10",
"ProductNDC": "29300-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040907",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3, 4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3, 4-dihydro-2H-1, 2, 4- benzothiadiazine-7-sulfonamide 1, 1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate."
},
{
"NDCCode": "31722-485-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-485-01) ",
"NDC11Code": "31722-0485-01",
"ProductNDC": "31722-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207418",
"LabelerName": "Camber Pharmaceuticals Inc",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251114",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride tablets USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the following inactive ingredients: lactose monohydrate; sodium starch glycolate; microcrystalline cellulose; colloidal silicon dioxide; magnesium stearate; FD&C Red no. 40 powder (10 mg only) and D&C Yellow No. 10 (15 mg, 20 mg and 30 mg only). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg respectively, of oxycodone free base."
},
{
"NDCCode": "31722-485-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (31722-485-05) ",
"NDC11Code": "31722-0485-05",
"ProductNDC": "31722-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207418",
"LabelerName": "Camber Pharmaceuticals Inc",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251114",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride tablets USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the following inactive ingredients: lactose monohydrate; sodium starch glycolate; microcrystalline cellulose; colloidal silicon dioxide; magnesium stearate; FD&C Red no. 40 powder (10 mg only) and D&C Yellow No. 10 (15 mg, 20 mg and 30 mg only). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg respectively, of oxycodone free base."
},
{
"NDCCode": "33261-485-01",
"PackageDescription": "100 mL in 1 BOTTLE (33261-485-01)",
"NDC11Code": "33261-0485-01",
"ProductNDC": "33261-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20060111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065234",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by S. pneumoniae and S. pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis. Skin and skin structure infections caused by staphylococci and/or streptococci. Bone infections caused by staphylococci and/or P. mirabilis. Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin for oral suspension and other antibacterial drugs, cephalexin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S H2O and the molecular weight is 365.41. Cephalexin has the following structural formula."
}
]
}
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<NDCList>
<NDC>
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<PackageDescription>1 INHALER in 1 CARTON (67296-0485-3) / 8 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>67296-0485-03</NDC11Code>
<ProductNDC>67296-0485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ventolin</ProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Redpharm Drug</LabelerName>
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<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VENTOLIN HFA is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2) .</IndicationAndUsage>
<Description>The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure:. Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. VENTOLIN HFA is a blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes.</Description>
</NDC>
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<PackageDescription>1 INHALER in 1 CARTON (67296-0485-1) / 18 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>67296-0485-01</NDC11Code>
<ProductNDC>67296-0485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ventolin</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
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<LabelerName>Redpharm Drug</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VENTOLIN HFA is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2) .</IndicationAndUsage>
<Description>The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure:. Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. VENTOLIN HFA is a blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray. Avoid spraying in eyes.</Description>
</NDC>
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<NDCCode>37662-0485-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-0485-3) </PackageDescription>
<NDC11Code>37662-0485-03</NDC11Code>
<ProductNDC>37662-0485</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Collinsonia Canadensis</ProprietaryName>
<NonProprietaryName>Collinsonia Canadensis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>COLLINSONIA CANADENSIS ROOT</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49288-0485-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0485-3)</PackageDescription>
<NDC11Code>49288-0485-03</NDC11Code>
<ProductNDC>49288-0485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>American Sycamore</ProprietaryName>
<NonProprietaryName>American Sycamore</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920413</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>PLATANUS OCCIDENTALIS POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>71335-0485-3</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-0485-3) </PackageDescription>
<NDC11Code>71335-0485-03</NDC11Code>
<ProductNDC>71335-0485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079088</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0406-0485-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0406-0485-01) </PackageDescription>
<NDC11Code>00406-0485-01</NDC11Code>
<ProductNDC>0406-0485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040419</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mgCodeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0406-0485-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0406-0485-05) </PackageDescription>
<NDC11Code>00406-0485-05</NDC11Code>
<ProductNDC>0406-0485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040419</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mgCodeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mgCodeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0485-0080-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0080-01) </PackageDescription>
<NDC11Code>00485-0080-01</NDC11Code>
<ProductNDC>0485-0080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rymed</ProprietaryName>
<NonProprietaryName>Dexchlorpheniramine Maleate And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0485-0098-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0485-0098-16) </PackageDescription>
<NDC11Code>00485-0098-16</NDC11Code>
<ProductNDC>0485-0098</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ed Chlorped Jr</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110304</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0485-0171-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0485-0171-16) </PackageDescription>
<NDC11Code>00485-0171-16</NDC11Code>
<ProductNDC>0485-0171</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ed A-hist Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 4; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 cough due to minor throat and bronchial irritation, 6 nasal congestion, 7 reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0485-0202-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0485-0202-16) </PackageDescription>
<NDC11Code>00485-0202-16</NDC11Code>
<ProductNDC>0485-0202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rynex Pe</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate And Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110307</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 2.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0485-0206-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0485-0206-16) </PackageDescription>
<NDC11Code>00485-0206-16</NDC11Code>
<ProductNDC>0485-0206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rynex Pse</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110307</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 15</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion 'reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0485-0208-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0485-0208-16) </PackageDescription>
<NDC11Code>00485-0208-16</NDC11Code>
<ProductNDC>0485-0208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ed Bron Gp</ProprietaryName>
<NonProprietaryName>Guaifenesin And Phenylephrine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100; 5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passages, 7 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0485-0210-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0210-01) </PackageDescription>
<NDC11Code>00485-0210-01</NDC11Code>
<ProductNDC>0485-0210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ed-a-hist Pse</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111008</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0485-0240-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0240-01) </PackageDescription>
<NDC11Code>00485-0240-01</NDC11Code>
<ProductNDC>0485-0240</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ed-a-hist Dm</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141027</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4; 10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 cough due to minor throat and bronchial irritation, 6 nasal congestion, 7 reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0485-0254-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0254-01) </PackageDescription>
<NDC11Code>00485-0254-01</NDC11Code>
<ProductNDC>0485-0254</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ed A-hist</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111008</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0597-0485-20</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0597-0485-20) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0480-12) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00597-0485-20</NDC11Code>
<ProductNDC>0597-0485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyltezo</ProprietaryName>
<NonProprietaryName>Adalimumab-adbm</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761058</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CYLTEZO is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. CYLTEZO (adalimumab-adbm) injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (CYLTEZO Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of CYLTEZO is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of CYLTEZO contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of CYLTEZO contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of CYLTEZO contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of CYLTEZO contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>13668-485-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13668-485-01) </PackageDescription>
<NDC11Code>13668-0485-01</NDC11Code>
<ProductNDC>13668-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065156</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride tablets, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.Respiratory tract infections caused by Mycoplasma pneumoniae.Lymphogranuloma venereum caused by Chlamydia trachomatis.Psittacosis (Ornithosis) due to Chlamydophila psittaci.Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by Chlamydia trachomatis.Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis.Relapsing fever due to Borrelia recurrentis.Chancroid caused by Haemophilus ducreyi.Plague due to Yersinia pestis.Tularemia due to Francisella tularensis.Cholera caused by Vibrio cholerae.Campylobacter fetus infections caused by Campylobacter fetus.Brucellosis due to Brucella species (in conjunction with streptomycin).Bartonellosis due to Bartonella bacilliformis.Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli.Klebsiella aerogenes Shigella species.Acinetobacter species.Respiratory tract infections caused by Haemophilus influenzae.Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride tablets, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory tract infections caused by Streptococcus pneumoniae.Skin and skin structure infections caused by Staphylococcus aureus. (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.Infections in women caused by Neisseria gonorrhoeae.Syphilis caused by Treponema pallidum subspecies pallidum.Yaws caused by Treponema pallidum subspecies pertenue.Listeriosis due to Listeria monocytogenes.Anthrax due to Bacillus anthracis.Vincent’s infection caused by Fusobacterium fusiforme.Actinomycosis caused by Actinomyces israelii.Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseriameningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets, USP and other antibacterial drugs, minocycline hydrochloride tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7- Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. Minocycline hydrochloride tablets, USP for oral administration, contains minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol 6000, silicified microcrystalline cellulose, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16714-485-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-485-01) </PackageDescription>
<NDC11Code>16714-0485-01</NDC11Code>
<ProductNDC>16714-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202419</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium extended-release tablets are indicated for: : 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis (2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release tablets USP 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid. Inactive Ingredients: FD&C Blue #1, FD&C Blue #2, hypromellose, mannitol, polyacrylate dispersion 40 percent, polyethylene glycol, pregelatinised starch (maize), propylene glycol, shellac glaze in ethanol, silicified microcrystalline cellulose, silicon dioxide, titanium dioxide, and triacetin. In addition, 500 mg tablets contain iron oxide black, iron oxide yellow, and polydextrose.Meets USP dissolution test 7.</Description>
</NDC>
<NDC>
<NDCCode>16714-485-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-485-02) </PackageDescription>
<NDC11Code>16714-0485-02</NDC11Code>
<ProductNDC>16714-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202419</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium extended-release tablets are indicated for: : 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis (2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release tablets USP 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid. Inactive Ingredients: FD&C Blue #1, FD&C Blue #2, hypromellose, mannitol, polyacrylate dispersion 40 percent, polyethylene glycol, pregelatinised starch (maize), propylene glycol, shellac glaze in ethanol, silicified microcrystalline cellulose, silicon dioxide, titanium dioxide, and triacetin. In addition, 500 mg tablets contain iron oxide black, iron oxide yellow, and polydextrose.Meets USP dissolution test 7.</Description>
</NDC>
<NDC>
<NDCCode>16729-485-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16729-485-01) </PackageDescription>
<NDC11Code>16729-0485-01</NDC11Code>
<ProductNDC>16729-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213342</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.,</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. ( 1.1) , 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1) , 3 Treatment of rheumatoid arthritis in adults. ( 1.2) , 4 >Treatment of systemic lupus erythematosus in adults. ( 1.3) , 5 Treatment of chronic discoid lupus erythematosus in adults. ( 1.4) .</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino]ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether. Hydroxychloroquine sulfate tablets, USP 100 mg for oral administration contain 100 mg hydroxychloroquine sulfate (equivalent to 77.5 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 200 mg for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 300 mg for oral administration contain 300 mg hydroxychloroquine sulfate (equivalent to 232.5 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 400 mg for oral administration contain 400 mg hydroxychloroquine sulfate (equivalent to 310 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16729-485-16</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (16729-485-16) </PackageDescription>
<NDC11Code>16729-0485-16</NDC11Code>
<ProductNDC>16729-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213342</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.,</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate is an antimalarial and antirheumatic indicated for the: 1 Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. ( 1.1) , 2 Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1) , 3 Treatment of rheumatoid arthritis in adults. ( 1.2) , 4 >Treatment of systemic lupus erythematosus in adults. ( 1.3) , 5 Treatment of chronic discoid lupus erythematosus in adults. ( 1.4) .</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino]ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether. Hydroxychloroquine sulfate tablets, USP 100 mg for oral administration contain 100 mg hydroxychloroquine sulfate (equivalent to 77.5 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 200 mg for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 300 mg for oral administration contain 300 mg hydroxychloroquine sulfate (equivalent to 232.5 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Hydroxychloroquine sulfate tablets, USP 400 mg for oral administration contain 400 mg hydroxychloroquine sulfate (equivalent to 310 mg base) and the following inactive ingredients: Lactose monohydrate, maize starch, magnesium stearate, povidone K30, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-485-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-485-30)</PackageDescription>
<NDC11Code>21695-0485-30</NDC11Code>
<ProductNDC>21695-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072750</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Symptomatic Gastroesophageal Reflux: Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform, practically insoluble in ether. Chemically, it is 4-amino-5-chloro- N-[2-(diethylamino) ethyl]-2-methoxybenzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22CIN3O2HClH2O Molecular Weight: 354.3. Each tablet for oral administration contains metoclopramide hydrochloride, equivalent to either 5 mg or 10 mg metoclopramide. Tablets also contain as inactive ingredients anhydrous lactose, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate and (5 mg only) D&C Yellow #10 and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>21695-485-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (21695-485-90)</PackageDescription>
<NDC11Code>21695-0485-90</NDC11Code>
<ProductNDC>21695-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072750</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Symptomatic Gastroesophageal Reflux: Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis): Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform, practically insoluble in ether. Chemically, it is 4-amino-5-chloro- N-[2-(diethylamino) ethyl]-2-methoxybenzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22CIN3O2HClH2O Molecular Weight: 354.3. Each tablet for oral administration contains metoclopramide hydrochloride, equivalent to either 5 mg or 10 mg metoclopramide. Tablets also contain as inactive ingredients anhydrous lactose, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate and (5 mg only) D&C Yellow #10 and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>24208-485-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (24208-485-10) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>24208-0485-10</NDC11Code>
<ProductNDC>24208-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dorzolamide Hcl</ProprietaryName>
<NonProprietaryName>Dorzolamide Hcl</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20090625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090143</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>DORZOLAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Dorzolamide hydrochloride ophthalmic solution, USP is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride USP is described chemically as: (4 S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4 H-thieno[2,3- b]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is:. Its empirical formula is C 10H 16N 2O 4S 3∙HCl and its structural formula is:. Dorzolamide hydrochloride USP has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide hydrochloride ophthalmic solution, USP is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride USP. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of dorzolamide hydrochloride ophthalmic solution USP, 2% contains 20 mg dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride USP). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>29300-485-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (29300-485-01) </PackageDescription>
<NDC11Code>29300-0485-01</NDC11Code>
<ProductNDC>29300-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040907</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3, 4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3, 4-dihydro-2H-1, 2, 4- benzothiadiazine-7-sulfonamide 1, 1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>29300-485-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (29300-485-10) </PackageDescription>
<NDC11Code>29300-0485-10</NDC11Code>
<ProductNDC>29300-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040907</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3, 4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3, 4-dihydro-2H-1, 2, 4- benzothiadiazine-7-sulfonamide 1, 1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>31722-485-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-485-01) </PackageDescription>
<NDC11Code>31722-0485-01</NDC11Code>
<ProductNDC>31722-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207418</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals Inc</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the following inactive ingredients: lactose monohydrate; sodium starch glycolate; microcrystalline cellulose; colloidal silicon dioxide; magnesium stearate; FD&C Red no. 40 powder (10 mg only) and D&C Yellow No. 10 (15 mg, 20 mg and 30 mg only). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>31722-485-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (31722-485-05) </PackageDescription>
<NDC11Code>31722-0485-05</NDC11Code>
<ProductNDC>31722-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207418</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals Inc</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the following inactive ingredients: lactose monohydrate; sodium starch glycolate; microcrystalline cellulose; colloidal silicon dioxide; magnesium stearate; FD&C Red no. 40 powder (10 mg only) and D&C Yellow No. 10 (15 mg, 20 mg and 30 mg only). The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9.0 mg, 13.5 mg, 18.0 mg and 27.0 mg respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>33261-485-01</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (33261-485-01)</PackageDescription>
<NDC11Code>33261-0485-01</NDC11Code>
<ProductNDC>33261-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065234</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by S. pneumoniae and S. pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis. Skin and skin structure infections caused by staphylococci and/or streptococci. Bone infections caused by staphylococci and/or P. mirabilis. Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin for oral suspension and other antibacterial drugs, cephalexin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S H2O and the molecular weight is 365.41. Cephalexin has the following structural formula.</Description>
</NDC>
</NDCList>