{
"NDC": [
{
"NDCCode": "71919-749-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-749-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0749-36",
"ProductNDC": "71919-749",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Fluorica",
"NonProprietaryName": "Calcium Fluoride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-741-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-741-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0741-36",
"ProductNDC": "71919-741",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Phosphoricum",
"NonProprietaryName": "Sodium Phosphate, Dibasic, Heptahydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-742-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-742-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0742-36",
"ProductNDC": "71919-742",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Sulphuricum",
"NonProprietaryName": "Sodium Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM SULFATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-743-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-743-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0743-36",
"ProductNDC": "71919-743",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Muriaticum",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-744-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-744-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0744-36",
"ProductNDC": "71919-744",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesia Phosphorica",
"NonProprietaryName": "Magnesium Phosphate, Dibasic Trihydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-745-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-745-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0745-36",
"ProductNDC": "71919-745",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kali Sulphuricum",
"NonProprietaryName": "Potassium Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "POTASSIUM SULFATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-746-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-746-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0746-36",
"ProductNDC": "71919-746",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kali Phosphoricum",
"NonProprietaryName": "Dibasic Potassium Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-747-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-747-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0747-36",
"ProductNDC": "71919-747",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kali Muriaticum",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-748-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-748-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0748-36",
"ProductNDC": "71919-748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Phosphoricum",
"NonProprietaryName": "Ferrosoferric Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERROSOFERRIC PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-750-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-750-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0750-36",
"ProductNDC": "71919-750",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Phosphorica",
"NonProprietaryName": "Tribasic Calcium Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-751-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-751-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0751-36",
"ProductNDC": "71919-751",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Sulphurica",
"NonProprietaryName": "Calcium Sulfate Anhydrous",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM SULFATE ANHYDROUS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-752-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-752-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0752-36",
"ProductNDC": "71919-752",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Silicea",
"NonProprietaryName": "Silicon Dioxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SILICON DIOXIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "71919-753-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (71919-753-36) > 300 TABLET in 1 BOTTLE, GLASS",
"NDC11Code": "71919-0753-36",
"ProductNDC": "71919-753",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cell Salts Combination",
"NonProprietaryName": "Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Dibasic Potassium Phosphate, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, Silicon Dioxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; CALCIUM FLUORIDE; SILICON DIOXIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180531",
"SamplePackage": "N"
},
{
"NDCCode": "70436-222-36",
"PackageDescription": "1 BOTTLE in 1 CARTON (70436-222-36) / 30 mL in 1 BOTTLE",
"NDC11Code": "70436-0222-36",
"ProductNDC": "70436-222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Dihydrate",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217036",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2025-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration ( 2)].",
"Description": "Azithromycin for Oral Suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0069-0400-10",
"PackageDescription": "10 VIAL in 1 CARTON (0069-0400-10) / 5 mL in 1 VIAL (0069-0400-01) ",
"NDC11Code": "00069-0400-10",
"ProductNDC": "0069-0400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140307",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050733",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140307",
"SamplePackage": "N",
"Description": "ZITHROMAX for injection (azithromycin for injection, USP) contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13- [(2,6-dideoxy-3-C-methyl-3-O -methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl- 11- [[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa- 6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785. ZITHROMAX for injection (azithromycin for injection, USP) consists of azithromycin dihydrate and the following inactive ingredients: anhydrous citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. ZITHROMAX for injection (azithromycin for injection, USP) is supplied as white to off-white lyophilized powder in a single-dose vial for intravenous administration. Each vial contains azithromycin dihydrate equivalent to 500 mg of azithromycin, 384.6 mg anhydrous citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of ZITHROMAX for intravenous injection with each mL containing azithromycin dihydrate equivalent to 100 mg of azithromycin, 76.9 mg anhydrous citric acid, and sodium hydroxide."
},
{
"NDCCode": "0069-3051-07",
"PackageDescription": "10 PACKET in 1 BOX (0069-3051-07) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0069-3051-01) ",
"NDC11Code": "00069-3051-07",
"ProductNDC": "0069-3051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19940928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050693",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19940928",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.",
"Description": "ZITHROMAX (azithromycin tablets and oral suspension) contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl- 3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.0. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets contain azithromycin dihydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, and an aqueous film coat consisting of hypromellose, titanium dioxide, lactose, and triacetin. ZITHROMAX for oral suspension is supplied in a single-dose packet containing azithromycin dihydrate equivalent to 1 g azithromycin. It also contains the following inactive ingredients: colloidal silicon dioxide, sodium phosphate tribasic, anhydrous; spray dried artificial banana flavor, spray dried artificial cherry flavor, and sucrose."
},
{
"NDCCode": "0069-3051-75",
"PackageDescription": "3 PACKET in 1 BOX (0069-3051-75) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0069-3051-01) ",
"NDC11Code": "00069-3051-75",
"ProductNDC": "0069-3051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19940928",
"EndMarketingDate": "20251026",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050693",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19940928",
"EndMarketingDatePackage": "20251026",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.",
"Description": "ZITHROMAX (azithromycin tablets and oral suspension) contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl- 3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.0. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets contain azithromycin dihydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, and an aqueous film coat consisting of hypromellose, titanium dioxide, lactose, and triacetin. ZITHROMAX for oral suspension is supplied in a single-dose packet containing azithromycin dihydrate equivalent to 1 g azithromycin. It also contains the following inactive ingredients: colloidal silicon dioxide, sodium phosphate tribasic, anhydrous; spray dried artificial banana flavor, spray dried artificial cherry flavor, and sucrose."
},
{
"NDCCode": "0069-3060-75",
"PackageDescription": "3 BLISTER PACK in 1 BOX (0069-3060-75) / 6 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00069-3060-75",
"ProductNDC": "0069-3060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050711",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960718",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-3070-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-3070-30) ",
"NDC11Code": "00069-3070-30",
"ProductNDC": "0069-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020524",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050784",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020524",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-3070-75",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0069-3070-75) / 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00069-3070-75",
"ProductNDC": "0069-3070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020524",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050784",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020524",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-3110-19",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-3110-19) / 15 mL in 1 BOTTLE",
"NDC11Code": "00069-3110-19",
"ProductNDC": "0069-3110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19951019",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050710",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19951019",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake. ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-3120-19",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-3120-19) / 15 mL in 1 BOTTLE",
"NDC11Code": "00069-3120-19",
"ProductNDC": "0069-3120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19951019",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050710",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951019",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-3130-19",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-3130-19) / 22.5 mL in 1 BOTTLE",
"NDC11Code": "00069-3130-19",
"ProductNDC": "0069-3130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19951019",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050710",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951019",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-3140-19",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-3140-19) / 30 mL in 1 BOTTLE",
"NDC11Code": "00069-3140-19",
"ProductNDC": "0069-3140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19951019",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050710",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951019",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-3150-83",
"PackageDescription": "10 VIAL in 1 CARTON (0069-3150-83) / 5 mL in 1 VIAL (0069-3150-84) ",
"NDC11Code": "00069-3150-83",
"ProductNDC": "0069-3150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19970130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050733",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19970130",
"SamplePackage": "N",
"Description": "ZITHROMAX for injection (azithromycin for injection, USP) contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13- [(2,6-dideoxy-3-C-methyl-3-O -methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl- 11- [[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa- 6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙ 2H2O and a molecular weight of 785. ZITHROMAX for injection (azithromycin for injection, USP) consists of azithromycin dihydrate and the following inactive ingredients: anhydrous citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. ZITHROMAX for injection (azithromycin for injection, USP) is supplied as white to off-white lyophilized powder in a single-dose vial for intravenous administration. Each vial contains azithromycin dihydrate equivalent to 500 mg of azithromycin, 384.6 mg anhydrous citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of ZITHROMAX for intravenous injection with each mL containing azithromycin dihydrate equivalent to 100 mg of azithromycin, 76.9 mg anhydrous citric acid, and sodium hydroxide."
},
{
"NDCCode": "0069-4061-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-4061-01) ",
"NDC11Code": "00069-4061-01",
"ProductNDC": "0069-4061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190517",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050711",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200504",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).",
"Description": "ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-4061-89",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (0069-4061-89) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00069-4061-89",
"ProductNDC": "0069-4061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190517",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050711",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190718",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake. ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0069-9500-01",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0069-9500-01) ",
"NDC11Code": "00069-9500-01",
"ProductNDC": "0069-9500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zithromax",
"NonProprietaryName": "Azithromycin Dihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake. ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin."
},
{
"NDCCode": "0093-2026-23",
"PackageDescription": "15 mL in 1 BOTTLE (0093-2026-23) ",
"NDC11Code": "00093-2026-23",
"ProductNDC": "0093-2026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20101217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065246",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"Description": "Azithromycin for oral suspension, USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C38H72N2O12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: amino methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP."
},
{
"NDCCode": "0093-2026-31",
"PackageDescription": "30 mL in 1 BOTTLE (0093-2026-31) ",
"NDC11Code": "00093-2026-31",
"ProductNDC": "0093-2026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20101217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065246",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20271231",
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"Description": "Azithromycin for oral suspension, USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C38H72N2O12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: amino methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP."
}
]
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<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-747-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-747-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0747-36</NDC11Code>
<ProductNDC>71919-747</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kali Muriaticum</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-748-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-748-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0748-36</NDC11Code>
<ProductNDC>71919-748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Phosphoricum</ProprietaryName>
<NonProprietaryName>Ferrosoferric Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERROSOFERRIC PHOSPHATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-750-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-750-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0750-36</NDC11Code>
<ProductNDC>71919-750</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Phosphorica</ProprietaryName>
<NonProprietaryName>Tribasic Calcium Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-751-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-751-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0751-36</NDC11Code>
<ProductNDC>71919-751</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Sulphurica</ProprietaryName>
<NonProprietaryName>Calcium Sulfate Anhydrous</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM SULFATE ANHYDROUS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-752-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-752-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0752-36</NDC11Code>
<ProductNDC>71919-752</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Silicea</ProprietaryName>
<NonProprietaryName>Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SILICON DIOXIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-753-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (71919-753-36) > 300 TABLET in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>71919-0753-36</NDC11Code>
<ProductNDC>71919-753</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cell Salts Combination</ProprietaryName>
<NonProprietaryName>Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Dibasic Potassium Phosphate, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180531</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; CALCIUM FLUORIDE; SILICON DIOXIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70436-222-36</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70436-222-36) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70436-0222-36</NDC11Code>
<ProductNDC>70436-222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Dihydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217036</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration ( 2)].</IndicationAndUsage>
<Description>Azithromycin for Oral Suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.0. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin dihydrate USP powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin USP. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0069-0400-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0069-0400-10) / 5 mL in 1 VIAL (0069-0400-01) </PackageDescription>
<NDC11Code>00069-0400-10</NDC11Code>
<ProductNDC>0069-0400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zithromax</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140307</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050733</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>ZITHROMAX for injection (azithromycin for injection, USP) contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13- [(2,6-dideoxy-3-C-methyl-3-O -methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl- 11- [[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa- 6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785. ZITHROMAX for injection (azithromycin for injection, USP) consists of azithromycin dihydrate and the following inactive ingredients: anhydrous citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. ZITHROMAX for injection (azithromycin for injection, USP) is supplied as white to off-white lyophilized powder in a single-dose vial for intravenous administration. Each vial contains azithromycin dihydrate equivalent to 500 mg of azithromycin, 384.6 mg anhydrous citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of ZITHROMAX for intravenous injection with each mL containing azithromycin dihydrate equivalent to 100 mg of azithromycin, 76.9 mg anhydrous citric acid, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0069-3051-07</NDCCode>
<PackageDescription>10 PACKET in 1 BOX (0069-3051-07) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0069-3051-01) </PackageDescription>
<NDC11Code>00069-3051-07</NDC11Code>
<ProductNDC>0069-3051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zithromax</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940928</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050693</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19940928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets and oral suspension) contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl- 3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.0. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets contain azithromycin dihydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, and an aqueous film coat consisting of hypromellose, titanium dioxide, lactose, and triacetin. ZITHROMAX for oral suspension is supplied in a single-dose packet containing azithromycin dihydrate equivalent to 1 g azithromycin. It also contains the following inactive ingredients: colloidal silicon dioxide, sodium phosphate tribasic, anhydrous; spray dried artificial banana flavor, spray dried artificial cherry flavor, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>0069-3051-75</NDCCode>
<PackageDescription>3 PACKET in 1 BOX (0069-3051-75) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0069-3051-01) </PackageDescription>
<NDC11Code>00069-3051-75</NDC11Code>
<ProductNDC>0069-3051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zithromax</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940928</StartMarketingDate>
<EndMarketingDate>20251026</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050693</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19940928</StartMarketingDatePackage>
<EndMarketingDatePackage>20251026</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets and oral suspension) contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl- 3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6- trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.0. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets contain azithromycin dihydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, and an aqueous film coat consisting of hypromellose, titanium dioxide, lactose, and triacetin. ZITHROMAX for oral suspension is supplied in a single-dose packet containing azithromycin dihydrate equivalent to 1 g azithromycin. It also contains the following inactive ingredients: colloidal silicon dioxide, sodium phosphate tribasic, anhydrous; spray dried artificial banana flavor, spray dried artificial cherry flavor, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>0069-3060-75</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX (0069-3060-75) / 6 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00069-3060-75</NDC11Code>
<ProductNDC>0069-3060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zithromax</ProprietaryName>
<NonProprietaryName>Azithromycin Dihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960718</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050711</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
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<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (0069-3070-75) / 3 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
<NDC>
<NDCCode>0069-3110-19</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0069-3110-19) / 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00069-3110-19</NDC11Code>
<ProductNDC>0069-3110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zithromax</ProprietaryName>
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<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951019</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050710</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake. ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
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<ProductNDC>0069-3120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
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<StartMarketingDate>19951019</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050710</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050710</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (0069-3140-19) / 30 mL in 1 BOTTLE</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
<NDC>
<NDCCode>0069-3150-83</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0069-3150-83) / 5 mL in 1 VIAL (0069-3150-84) </PackageDescription>
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<ProductNDC>0069-3150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19970130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050733</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
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<StartMarketingDatePackage>19970130</StartMarketingDatePackage>
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<Description>ZITHROMAX for injection (azithromycin for injection, USP) contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13- [(2,6-dideoxy-3-C-methyl-3-O -methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl- 11- [[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa- 6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙ 2H2O and a molecular weight of 785. ZITHROMAX for injection (azithromycin for injection, USP) consists of azithromycin dihydrate and the following inactive ingredients: anhydrous citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. ZITHROMAX for injection (azithromycin for injection, USP) is supplied as white to off-white lyophilized powder in a single-dose vial for intravenous administration. Each vial contains azithromycin dihydrate equivalent to 500 mg of azithromycin, 384.6 mg anhydrous citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of ZITHROMAX for intravenous injection with each mL containing azithromycin dihydrate equivalent to 100 mg of azithromycin, 76.9 mg anhydrous citric acid, and sodium hydroxide.</Description>
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<NDCCode>0069-4061-01</NDCCode>
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<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2026-07-28</LastUpdate>
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<IndicationAndUsage>ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 1 Acute bacterial exacerbations of chronic bronchitis in adults (1.1), 2 Acute bacterial sinusitis in adults (1.1), 3 Uncomplicated skin and skin structure infections in adults (1.1), 4 Urethritis and cervicitis in adults (1.1), 5 Genital ulcer disease in men (1.1), 6 Acute otitis media in pediatric patients (6 months of age and older) (1.2), 7 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2), 8 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2).</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin. ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
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<StartMarketingDatePackage>20190718</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake. ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
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<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
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<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake. ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.</Description>
</NDC>
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<NDCCode>0093-2026-23</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (0093-2026-23) </PackageDescription>
<NDC11Code>00093-2026-23</NDC11Code>
<ProductNDC>0093-2026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
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<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065246</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Azithromycin for oral suspension, USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C38H72N2O12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: amino methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP.</Description>
</NDC>
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<NDCCode>0093-2026-31</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (0093-2026-31) </PackageDescription>
<NDC11Code>00093-2026-31</NDC11Code>
<ProductNDC>0093-2026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<ApplicationNumber>ANDA065246</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Azithromycin for oral suspension, USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C38H72N2O12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: amino methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP.</Description>
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