{
"NDC": [
{
"NDCCode": "60986-1024-7",
"PackageDescription": "236 mL in 1 BOTTLE, GLASS (60986-1024-7)",
"NDC11Code": "60986-1024-07",
"ProductNDC": "60986-1024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Female Tonic",
"NonProprietaryName": "Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimi",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ALCHEMILLA XANTHOCHLORA FLOWERING TOP; GALIUM ODORATUM; MATRICARIA RECUTITA; VIOLA ODORATA; CINCHONA OFFICINALIS BARK; MENTHA PIPERITA; ROSMARINUS OFFICINALIS FLOWERING TOP; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; AMBERGRIS; BLACK COHOSH; CONVALLARIA MAJALIS; SAFFRON; CYCLAMEN PURPURASCENS TUBER; TURNERA DIFFUSA LEAFY TWIG; GOLDENSEAL; CAULOPHYLLUM THALICTROIDES ROOT; LILIUM LANCIFOLIUM FLOWERING TOP; PACKERA AUREA; DELPHINIUM STAPHISAGRIA SEED; NAJA NAJA VENOM",
"StrengthNumber": "1; 1; 1; 1; 2; 1; 1; 1; 2; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age."
},
{
"NDCCode": "71335-1024-7",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71335-1024-7) ",
"NDC11Code": "71335-1024-07",
"ProductNDC": "71335-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211228",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "60986-1014-7",
"PackageDescription": "236 mL in 1 BOTTLE, GLASS (60986-1014-7) ",
"NDC11Code": "60986-1014-07",
"ProductNDC": "60986-1014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Contessa",
"NonProprietaryName": "Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ALCHEMILLA XANTHOCHLORA FLOWERING TOP; GALIUM ODORATUM; MATRICARIA RECUTITA; VIOLA ODORATA; CINCHONA OFFICINALIS BARK; MENTHA PIPERITA; ROSMARINUS OFFICINALIS FLOWERING TOP; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; AMBERGRIS; BLACK COHOSH; CONVALLARIA MAJALIS; SAFFRON; CYCLAMEN PURPURASCENS TUBER; TURNERA DIFFUSA LEAFY TWIG; GOLDENSEAL; CAULOPHYLLUM THALICTROIDES ROOT; LILIUM LANCIFOLIUM FLOWERING TOP; PACKERA AUREA; DELPHINIUM STAPHISAGRIA SEED; NAJA NAJA VENOM",
"StrengthNumber": "1; 1; 1; 1; 2; 1; 1; 1; 2; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111206",
"SamplePackage": "N",
"IndicationAndUsage": "Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age."
},
{
"NDCCode": "60986-1033-7",
"PackageDescription": "236 mL in 1 BOTTLE, GLASS (60986-1033-7) ",
"NDC11Code": "60986-1033-07",
"ProductNDC": "60986-1033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Female Tonic",
"NonProprietaryName": "Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ALCHEMILLA XANTHOCHLORA FLOWERING TOP; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; GALIUM ODORATUM; GOLDENSEAL; LILIUM LANCIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; MENTHA PIPERITA; NAJA NAJA VENOM; PACKERA AUREA; ROSMARINUS OFFICINALIS FLOWERING TOP; SAFFRON; TURNERA DIFFUSA LEAFY TWIG; VALERIAN; VIOLA ODORATA",
"StrengthNumber": "1; 3; 4; 2; 3; 2; 3; 3; 4; 1; 3; 4; 1; 1; 8; 4; 1; 3; 3; 1; 1",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age."
},
{
"NDCCode": "53808-1024-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1024-1)",
"NDC11Code": "53808-1024-01",
"ProductNDC": "53808-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078384",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).",
"Description": "Carvedilol Tablet is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "71335-1024-1",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (71335-1024-1) ",
"NDC11Code": "71335-1024-01",
"ProductNDC": "71335-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181228",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "71335-1024-2",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (71335-1024-2) ",
"NDC11Code": "71335-1024-02",
"ProductNDC": "71335-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211228",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "71335-1024-3",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (71335-1024-3) ",
"NDC11Code": "71335-1024-03",
"ProductNDC": "71335-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181210",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "71335-1024-4",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71335-1024-4) ",
"NDC11Code": "71335-1024-04",
"ProductNDC": "71335-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211228",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "71335-1024-5",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71335-1024-5) ",
"NDC11Code": "71335-1024-05",
"ProductNDC": "71335-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211228",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "71335-1024-6",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (71335-1024-6) ",
"NDC11Code": "71335-1024-06",
"ProductNDC": "71335-1024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181211",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "60986-1003-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1003-3) ",
"NDC11Code": "60986-1003-03",
"ProductNDC": "60986-1003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allernest",
"NonProprietaryName": "Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP",
"StrengthNumber": "12; 8; 6; 6; 6; 4; 4; 4; 4; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180227",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: in acute disorders, take 10 drops every 15 minutes on the tongue or with water until improvement if felt, then take 10 drops less frequently. To maintain balance, take 15 drops three times daily. Children receive 1/2 of the adult amount."
},
{
"NDCCode": "60986-1003-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1003-4) ",
"NDC11Code": "60986-1003-04",
"ProductNDC": "60986-1003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allernest",
"NonProprietaryName": "Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP",
"StrengthNumber": "12; 8; 6; 6; 6; 4; 4; 4; 4; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180227",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: in acute disorders, take 10 drops every 15 minutes on the tongue or with water until improvement if felt, then take 10 drops less frequently. To maintain balance, take 15 drops three times daily. Children receive 1/2 of the adult amount."
},
{
"NDCCode": "60986-1004-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1004-3) ",
"NDC11Code": "60986-1004-03",
"ProductNDC": "60986-1004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lymphonest",
"NonProprietaryName": "Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT",
"StrengthNumber": "1; 1; 3; 3; 1; 12; 10; 10; 8; 6",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "30 drops in water 3 times daily. In acute stages, take 50 drops at once followed by 30 drops 4 times daily. Children receive one half or less of the adult amount."
},
{
"NDCCode": "60986-1004-4",
"PackageDescription": "100 mL in 1 PACKAGE (60986-1004-4) ",
"NDC11Code": "60986-1004-04",
"ProductNDC": "60986-1004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lymphonest",
"NonProprietaryName": "Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT",
"StrengthNumber": "1; 1; 3; 3; 1; 12; 10; 10; 8; 6",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "30 drops in water 3 times daily. In acute stages, take 50 drops at once followed by 30 drops 4 times daily. Children receive one half or less of the adult amount."
},
{
"NDCCode": "60986-1008-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1008-3) ",
"NDC11Code": "60986-1008-03",
"ProductNDC": "60986-1008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cholenest",
"NonProprietaryName": "Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER",
"StrengthNumber": "1; 1; 1; 1; 2; 2; 2; 6; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180227",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals."
},
{
"NDCCode": "60986-1008-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1008-4) ",
"NDC11Code": "60986-1008-04",
"ProductNDC": "60986-1008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cholenest",
"NonProprietaryName": "Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER",
"StrengthNumber": "1; 1; 1; 1; 2; 2; 2; 6; 8; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180227",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals."
},
{
"NDCCode": "60986-1009-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1009-3) ",
"NDC11Code": "60986-1009-03",
"ProductNDC": "60986-1009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sabal Serrulatum",
"NonProprietaryName": "Sabal Serulatum, Lycopodium Clavatum, Pareira Brava",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "SAW PALMETTO; LYCOPODIUM CLAVATUM SPORE; CHONDRODENDRON TOMENTOSUM ROOT",
"StrengthNumber": "1; 4; 4",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "In acute disorders, take 10 drops in pure water every hour until improvement is felt. Then take 25 drops in pure water three times daily after or between meals."
},
{
"NDCCode": "60986-1009-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1009-4) ",
"NDC11Code": "60986-1009-04",
"ProductNDC": "60986-1009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sabal Serrulatum",
"NonProprietaryName": "Sabal Serulatum, Lycopodium Clavatum, Pareira Brava",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "SAW PALMETTO; LYCOPODIUM CLAVATUM SPORE; CHONDRODENDRON TOMENTOSUM ROOT",
"StrengthNumber": "1; 4; 4",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "In acute disorders, take 10 drops in pure water every hour until improvement is felt. Then take 25 drops in pure water three times daily after or between meals."
},
{
"NDCCode": "60986-1011-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1011-3) ",
"NDC11Code": "60986-1011-03",
"ProductNDC": "60986-1011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rubus",
"NonProprietaryName": "Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "BLACKBERRY; IRIS X GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK",
"StrengthNumber": "2; 4; 3; 3; 6",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920301",
"SamplePackage": "N",
"IndicationAndUsage": "Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening."
},
{
"NDCCode": "60986-1011-4",
"PackageDescription": "100 mL in 1 PACKAGE (60986-1011-4) ",
"NDC11Code": "60986-1011-04",
"ProductNDC": "60986-1011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rubus",
"NonProprietaryName": "Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "BLACKBERRY; IRIS X GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK",
"StrengthNumber": "2; 4; 3; 3; 6",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920301",
"SamplePackage": "N",
"IndicationAndUsage": "Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening."
},
{
"NDCCode": "60986-1013-3",
"PackageDescription": "10 mL in 1 BOTTLE, SPRAY (60986-1013-3) ",
"NDC11Code": "60986-1013-03",
"ProductNDC": "60986-1013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrastis",
"NonProprietaryName": "Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; EPHEDRA DISTACHYA FLOWERING TWIG; DAPHNE MEZEREUM BARK; KEROSENE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "4; 3; 3; 3; 8; 3; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N"
},
{
"NDCCode": "60986-1013-4",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (60986-1013-4) ",
"NDC11Code": "60986-1013-04",
"ProductNDC": "60986-1013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrastis",
"NonProprietaryName": "Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; EPHEDRA DISTACHYA FLOWERING TWIG; DAPHNE MEZEREUM BARK; KEROSENE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "4; 3; 3; 3; 8; 3; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N"
},
{
"NDCCode": "60986-1013-5",
"PackageDescription": "20 mL in 1 BOTTLE, SPRAY (60986-1013-5) ",
"NDC11Code": "60986-1013-05",
"ProductNDC": "60986-1013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrastis",
"NonProprietaryName": "Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "DAPHNE MEZEREUM BARK; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; KEROSENE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "3; 3; 4; 8; 3; 3; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211210",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children."
},
{
"NDCCode": "60986-1015-5",
"PackageDescription": "20 mL in 1 BOTTLE, SPRAY (60986-1015-5) ",
"NDC11Code": "60986-1015-05",
"ProductNDC": "60986-1015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrastis",
"NonProprietaryName": "Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20230102",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC",
"SubstanceName": "DAPHNE MEZEREUM BARK; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; KEROSENE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "3; 3; 4; 8; 3; 3; 10",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230102",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness."
},
{
"NDCCode": "60986-1016-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1016-3) ",
"NDC11Code": "60986-1016-03",
"ProductNDC": "60986-1016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trillium",
"NonProprietaryName": "Calendula Officinalis, Chamomilla, Crocus Sativus, Equisetum Arvense, Hamamelis Virginiana, Lamium Album, Millefolium, Plantago Major, Quercus Robur, Thlaspi Bursa-pastoris, Trillium Pendulum, Urtica Dioica, Viscum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; SAFFRON; EQUISETUM ARVENSE TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LAMIUM ALBUM; ACHILLEA MILLEFOLIUM; PLANTAGO MAJOR; QUERCUS ROBUR FLOWER; CAPSELLA BURSA-PASTORIS; TRILLIUM ERECTUM WHOLE; URTICA DIOICA; VISCUM ALBUM WHOLE",
"StrengthNumber": "1; 1; 3; 1; 1; 1; 1; 1; 1; 1; 2; 1; 3",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N"
},
{
"NDCCode": "60986-1017-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1017-3) ",
"NDC11Code": "60986-1017-03",
"ProductNDC": "60986-1017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trillium",
"NonProprietaryName": "Calendula Officinalis, Chamomilla, Crocus Sativus, Hamamelis Virginiana, Millefolium, Thlaspi Bursa-pastoris, Trillium Pendulum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20201230",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "ACHILLEA MILLEFOLIUM; CALENDULA OFFICINALIS FLOWERING TOP; CAPSELLA BURSA-PASTORIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MATRICARIA RECUTITA; SAFFRON; TRILLIUM ERECTUM WHOLE",
"StrengthNumber": "1; 1; 1; 1; 1; 3; 2",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201230",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals."
},
{
"NDCCode": "60986-1019-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1019-3) ",
"NDC11Code": "60986-1019-03",
"ProductNDC": "60986-1019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lithium",
"NonProprietaryName": "Lithium Bromatum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "LITHIUM BROMIDE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/mL",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: Take 20 drops on the toungue or in water two to three times daily. Children receive 1/2 of the adult amount."
},
{
"NDCCode": "60986-1019-4",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (60986-1019-4) ",
"NDC11Code": "60986-1019-04",
"ProductNDC": "60986-1019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lithium",
"NonProprietaryName": "Lithium Bromatum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "LITHIUM BROMIDE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/mL",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: Take 20 drops on the toungue or in water two to three times daily. Children receive 1/2 of the adult amount."
},
{
"NDCCode": "60986-1020-3",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (60986-1020-3) ",
"NDC11Code": "60986-1020-03",
"ProductNDC": "60986-1020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Solidago",
"NonProprietaryName": "Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19920301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Marco Pharma International LLC.",
"SubstanceName": "SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; POPULUS TREMULOIDES BARK; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; LARIX DECIDUA RESIN; SODIUM BORATE",
"StrengthNumber": "1; 1; 3; 1; 2; 3; 4; 6; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180228",
"SamplePackage": "N",
"IndicationAndUsage": "Adults: Take 40 drops in tepid water three times daily. For severe symptoms, take 40 drops four to five time daily. After improvement is felt, take 40 drops three times daily. Children receive 1/2 or less of the adult amount."
}
]
}
{"NDC":[{"NDCCode":"60986-1024-7","ProprietaryName":"Female Tonic","NonProprietaryName":"Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimi"},{"NDCCode":"71335-1024-7","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"60986-1014-7","ProprietaryName":"Contessa","NonProprietaryName":"Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians"},{"NDCCode":"60986-1033-7","ProprietaryName":"Female Tonic","NonProprietaryName":"Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians"},{"NDCCode":"53808-1024-1","ProprietaryName":"Carvedilol","NonProprietaryName":"Carvedilol"},{"NDCCode":"71335-1024-1","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"71335-1024-2","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"71335-1024-3","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"71335-1024-4","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"71335-1024-5","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"71335-1024-6","ProprietaryName":"Ciprofloxacin","NonProprietaryName":"Ciprofloxacin Hydrochloride"},{"NDCCode":"60986-1003-3","ProprietaryName":"Allernest","NonProprietaryName":"Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum"},{"NDCCode":"60986-1003-4","ProprietaryName":"Allernest","NonProprietaryName":"Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum"},{"NDCCode":"60986-1004-3","ProprietaryName":"Lymphonest","NonProprietaryName":"Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis"},{"NDCCode":"60986-1004-4","ProprietaryName":"Lymphonest","NonProprietaryName":"Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis"},{"NDCCode":"60986-1008-3","ProprietaryName":"Cholenest","NonProprietaryName":"Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum"},{"NDCCode":"60986-1008-4","ProprietaryName":"Cholenest","NonProprietaryName":"Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum"},{"NDCCode":"60986-1009-3","ProprietaryName":"Sabal Serrulatum","NonProprietaryName":"Sabal Serulatum, Lycopodium Clavatum, Pareira Brava"},{"NDCCode":"60986-1009-4","ProprietaryName":"Sabal Serrulatum","NonProprietaryName":"Sabal Serulatum, Lycopodium Clavatum, Pareira Brava"},{"NDCCode":"60986-1011-3","ProprietaryName":"Rubus","NonProprietaryName":"Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei"},{"NDCCode":"60986-1011-4","ProprietaryName":"Rubus","NonProprietaryName":"Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei"},{"NDCCode":"60986-1013-3","ProprietaryName":"Hydrastis","NonProprietaryName":"Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,"},{"NDCCode":"60986-1013-4","ProprietaryName":"Hydrastis","NonProprietaryName":"Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,"},{"NDCCode":"60986-1013-5","ProprietaryName":"Hydrastis","NonProprietaryName":"Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,"},{"NDCCode":"60986-1015-5","ProprietaryName":"Hydrastis","NonProprietaryName":"Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis"},{"NDCCode":"60986-1016-3","ProprietaryName":"Trillium","NonProprietaryName":"Calendula Officinalis, Chamomilla, Crocus Sativus, Equisetum Arvense, Hamamelis Virginiana, Lamium Album, Millefolium, Plantago Major, Quercus Robur, Thlaspi Bursa-pastoris, Trillium Pendulum, Urtica Dioica, Viscum Album"},{"NDCCode":"60986-1017-3","ProprietaryName":"Trillium","NonProprietaryName":"Calendula Officinalis, Chamomilla, Crocus Sativus, Hamamelis Virginiana, Millefolium, Thlaspi Bursa-pastoris, Trillium Pendulum"},{"NDCCode":"60986-1019-3","ProprietaryName":"Lithium","NonProprietaryName":"Lithium Bromatum"},{"NDCCode":"60986-1019-4","ProprietaryName":"Lithium","NonProprietaryName":"Lithium Bromatum"},{"NDCCode":"60986-1020-3","ProprietaryName":"Solidago","NonProprietaryName":"Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax"}]}
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<NDCList>
<NDC>
<NDCCode>60986-1024-7</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, GLASS (60986-1024-7)</PackageDescription>
<NDC11Code>60986-1024-07</NDC11Code>
<ProductNDC>60986-1024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Female Tonic</ProprietaryName>
<NonProprietaryName>Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimi</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ALCHEMILLA XANTHOCHLORA FLOWERING TOP; GALIUM ODORATUM; MATRICARIA RECUTITA; VIOLA ODORATA; CINCHONA OFFICINALIS BARK; MENTHA PIPERITA; ROSMARINUS OFFICINALIS FLOWERING TOP; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; AMBERGRIS; BLACK COHOSH; CONVALLARIA MAJALIS; SAFFRON; CYCLAMEN PURPURASCENS TUBER; TURNERA DIFFUSA LEAFY TWIG; GOLDENSEAL; CAULOPHYLLUM THALICTROIDES ROOT; LILIUM LANCIFOLIUM FLOWERING TOP; PACKERA AUREA; DELPHINIUM STAPHISAGRIA SEED; NAJA NAJA VENOM</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 2; 1; 1; 1; 2; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-1024-7</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71335-1024-7) </PackageDescription>
<NDC11Code>71335-1024-07</NDC11Code>
<ProductNDC>71335-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211228</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60986-1014-7</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, GLASS (60986-1014-7) </PackageDescription>
<NDC11Code>60986-1014-07</NDC11Code>
<ProductNDC>60986-1014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Contessa</ProprietaryName>
<NonProprietaryName>Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ALCHEMILLA XANTHOCHLORA FLOWERING TOP; GALIUM ODORATUM; MATRICARIA RECUTITA; VIOLA ODORATA; CINCHONA OFFICINALIS BARK; MENTHA PIPERITA; ROSMARINUS OFFICINALIS FLOWERING TOP; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; AMBERGRIS; BLACK COHOSH; CONVALLARIA MAJALIS; SAFFRON; CYCLAMEN PURPURASCENS TUBER; TURNERA DIFFUSA LEAFY TWIG; GOLDENSEAL; CAULOPHYLLUM THALICTROIDES ROOT; LILIUM LANCIFOLIUM FLOWERING TOP; PACKERA AUREA; DELPHINIUM STAPHISAGRIA SEED; NAJA NAJA VENOM</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 2; 1; 1; 1; 2; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age.</IndicationAndUsage>
</NDC>
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<NDCCode>60986-1033-7</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, GLASS (60986-1033-7) </PackageDescription>
<NDC11Code>60986-1033-07</NDC11Code>
<ProductNDC>60986-1033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Female Tonic</ProprietaryName>
<NonProprietaryName>Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ALCHEMILLA XANTHOCHLORA FLOWERING TOP; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; GALIUM ODORATUM; GOLDENSEAL; LILIUM LANCIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; MENTHA PIPERITA; NAJA NAJA VENOM; PACKERA AUREA; ROSMARINUS OFFICINALIS FLOWERING TOP; SAFFRON; TURNERA DIFFUSA LEAFY TWIG; VALERIAN; VIOLA ODORATA</SubstanceName>
<StrengthNumber>1; 3; 4; 2; 3; 2; 3; 3; 4; 1; 3; 4; 1; 1; 8; 4; 1; 3; 3; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53808-1024-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (53808-1024-1)</PackageDescription>
<NDC11Code>53808-1024-01</NDC11Code>
<ProductNDC>53808-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078384</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2), 2 Hypertension (1.3).</IndicationAndUsage>
<Description>Carvedilol Tablet is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol Tablet is a racemic mixture with the following structure. Carvedilol Tablet is a white, oval-shaped, biconvex film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of Carvedilol Tablet. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate dihydrate, sucrose, and titanium dioxide. Carvedilol Tablet is a white to off-white powder with a molecular weight of 406.5 and molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>71335-1024-1</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (71335-1024-1) </PackageDescription>
<NDC11Code>71335-1024-01</NDC11Code>
<ProductNDC>71335-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181228</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-1024-2</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (71335-1024-2) </PackageDescription>
<NDC11Code>71335-1024-02</NDC11Code>
<ProductNDC>71335-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211228</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-1024-3</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (71335-1024-3) </PackageDescription>
<NDC11Code>71335-1024-03</NDC11Code>
<ProductNDC>71335-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-1024-4</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71335-1024-4) </PackageDescription>
<NDC11Code>71335-1024-04</NDC11Code>
<ProductNDC>71335-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211228</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-1024-5</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71335-1024-5) </PackageDescription>
<NDC11Code>71335-1024-05</NDC11Code>
<ProductNDC>71335-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211228</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71335-1024-6</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (71335-1024-6) </PackageDescription>
<NDC11Code>71335-1024-06</NDC11Code>
<ProductNDC>71335-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181211</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60986-1003-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1003-3) </PackageDescription>
<NDC11Code>60986-1003-03</NDC11Code>
<ProductNDC>60986-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allernest</ProprietaryName>
<NonProprietaryName>Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP</SubstanceName>
<StrengthNumber>12; 8; 6; 6; 6; 4; 4; 4; 4; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: in acute disorders, take 10 drops every 15 minutes on the tongue or with water until improvement if felt, then take 10 drops less frequently. To maintain balance, take 15 drops three times daily. Children receive 1/2 of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1003-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1003-4) </PackageDescription>
<NDC11Code>60986-1003-04</NDC11Code>
<ProductNDC>60986-1003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allernest</ProprietaryName>
<NonProprietaryName>Formicum Acidum, Lachesis Mutus, Luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai Racemosa,galphimia Glauca, Thuja Occidentalis, Urtica Dicica And Cardiospermum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP</SubstanceName>
<StrengthNumber>12; 8; 6; 6; 6; 4; 4; 4; 4; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: in acute disorders, take 10 drops every 15 minutes on the tongue or with water until improvement if felt, then take 10 drops less frequently. To maintain balance, take 15 drops three times daily. Children receive 1/2 of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1004-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1004-3) </PackageDescription>
<NDC11Code>60986-1004-03</NDC11Code>
<ProductNDC>60986-1004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lymphonest</ProprietaryName>
<NonProprietaryName>Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT</SubstanceName>
<StrengthNumber>1; 1; 3; 3; 1; 12; 10; 10; 8; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>30 drops in water 3 times daily. In acute stages, take 50 drops at once followed by 30 drops 4 times daily. Children receive one half or less of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1004-4</NDCCode>
<PackageDescription>100 mL in 1 PACKAGE (60986-1004-4) </PackageDescription>
<NDC11Code>60986-1004-04</NDC11Code>
<ProductNDC>60986-1004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lymphonest</ProprietaryName>
<NonProprietaryName>Echinacea Augustifolia, Scrophularia Nodosa, Abrotanum, Petroleum, Aloe Socotrina, Mercurius Solubilis, Crotalus Horiidus, Thuja Occidentalis, Lachesis Mutus, Aristolochia Clematitis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT</SubstanceName>
<StrengthNumber>1; 1; 3; 3; 1; 12; 10; 10; 8; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>30 drops in water 3 times daily. In acute stages, take 50 drops at once followed by 30 drops 4 times daily. Children receive one half or less of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1008-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1008-3) </PackageDescription>
<NDC11Code>60986-1008-03</NDC11Code>
<ProductNDC>60986-1008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cholenest</ProprietaryName>
<NonProprietaryName>Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 2; 2; 2; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1008-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1008-4) </PackageDescription>
<NDC11Code>60986-1008-04</NDC11Code>
<ProductNDC>60986-1008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cholenest</ProprietaryName>
<NonProprietaryName>Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 2; 2; 2; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1009-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1009-3) </PackageDescription>
<NDC11Code>60986-1009-03</NDC11Code>
<ProductNDC>60986-1009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sabal Serrulatum</ProprietaryName>
<NonProprietaryName>Sabal Serulatum, Lycopodium Clavatum, Pareira Brava</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>SAW PALMETTO; LYCOPODIUM CLAVATUM SPORE; CHONDRODENDRON TOMENTOSUM ROOT</SubstanceName>
<StrengthNumber>1; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In acute disorders, take 10 drops in pure water every hour until improvement is felt. Then take 25 drops in pure water three times daily after or between meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1009-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1009-4) </PackageDescription>
<NDC11Code>60986-1009-04</NDC11Code>
<ProductNDC>60986-1009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sabal Serrulatum</ProprietaryName>
<NonProprietaryName>Sabal Serulatum, Lycopodium Clavatum, Pareira Brava</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>SAW PALMETTO; LYCOPODIUM CLAVATUM SPORE; CHONDRODENDRON TOMENTOSUM ROOT</SubstanceName>
<StrengthNumber>1; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In acute disorders, take 10 drops in pure water every hour until improvement is felt. Then take 25 drops in pure water three times daily after or between meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1011-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1011-3) </PackageDescription>
<NDC11Code>60986-1011-03</NDC11Code>
<ProductNDC>60986-1011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rubus</ProprietaryName>
<NonProprietaryName>Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>BLACKBERRY; IRIS X GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK</SubstanceName>
<StrengthNumber>2; 4; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1011-4</NDCCode>
<PackageDescription>100 mL in 1 PACKAGE (60986-1011-4) </PackageDescription>
<NDC11Code>60986-1011-04</NDC11Code>
<ProductNDC>60986-1011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rubus</ProprietaryName>
<NonProprietaryName>Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>BLACKBERRY; IRIS X GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK</SubstanceName>
<StrengthNumber>2; 4; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1013-3</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, SPRAY (60986-1013-3) </PackageDescription>
<NDC11Code>60986-1013-03</NDC11Code>
<ProductNDC>60986-1013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrastis</ProprietaryName>
<NonProprietaryName>Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; EPHEDRA DISTACHYA FLOWERING TWIG; DAPHNE MEZEREUM BARK; KEROSENE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>4; 3; 3; 3; 8; 3; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60986-1013-4</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (60986-1013-4) </PackageDescription>
<NDC11Code>60986-1013-04</NDC11Code>
<ProductNDC>60986-1013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrastis</ProprietaryName>
<NonProprietaryName>Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; EPHEDRA DISTACHYA FLOWERING TWIG; DAPHNE MEZEREUM BARK; KEROSENE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>4; 3; 3; 3; 8; 3; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60986-1013-5</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, SPRAY (60986-1013-5) </PackageDescription>
<NDC11Code>60986-1013-05</NDC11Code>
<ProductNDC>60986-1013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrastis</ProprietaryName>
<NonProprietaryName>Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis,</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>DAPHNE MEZEREUM BARK; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; KEROSENE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>3; 3; 4; 8; 3; 3; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1015-5</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, SPRAY (60986-1015-5) </PackageDescription>
<NDC11Code>60986-1015-05</NDC11Code>
<ProductNDC>60986-1015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrastis</ProprietaryName>
<NonProprietaryName>Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20230102</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC</LabelerName>
<SubstanceName>DAPHNE MEZEREUM BARK; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; KEROSENE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>3; 3; 4; 8; 3; 3; 10</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1016-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1016-3) </PackageDescription>
<NDC11Code>60986-1016-03</NDC11Code>
<ProductNDC>60986-1016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trillium</ProprietaryName>
<NonProprietaryName>Calendula Officinalis, Chamomilla, Crocus Sativus, Equisetum Arvense, Hamamelis Virginiana, Lamium Album, Millefolium, Plantago Major, Quercus Robur, Thlaspi Bursa-pastoris, Trillium Pendulum, Urtica Dioica, Viscum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; SAFFRON; EQUISETUM ARVENSE TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LAMIUM ALBUM; ACHILLEA MILLEFOLIUM; PLANTAGO MAJOR; QUERCUS ROBUR FLOWER; CAPSELLA BURSA-PASTORIS; TRILLIUM ERECTUM WHOLE; URTICA DIOICA; VISCUM ALBUM WHOLE</SubstanceName>
<StrengthNumber>1; 1; 3; 1; 1; 1; 1; 1; 1; 1; 2; 1; 3</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60986-1017-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1017-3) </PackageDescription>
<NDC11Code>60986-1017-03</NDC11Code>
<ProductNDC>60986-1017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trillium</ProprietaryName>
<NonProprietaryName>Calendula Officinalis, Chamomilla, Crocus Sativus, Hamamelis Virginiana, Millefolium, Thlaspi Bursa-pastoris, Trillium Pendulum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201230</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM; CALENDULA OFFICINALIS FLOWERING TOP; CAPSELLA BURSA-PASTORIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MATRICARIA RECUTITA; SAFFRON; TRILLIUM ERECTUM WHOLE</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 1; 3; 2</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1019-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1019-3) </PackageDescription>
<NDC11Code>60986-1019-03</NDC11Code>
<ProductNDC>60986-1019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lithium</ProprietaryName>
<NonProprietaryName>Lithium Bromatum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>LITHIUM BROMIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: Take 20 drops on the toungue or in water two to three times daily. Children receive 1/2 of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1019-4</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (60986-1019-4) </PackageDescription>
<NDC11Code>60986-1019-04</NDC11Code>
<ProductNDC>60986-1019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lithium</ProprietaryName>
<NonProprietaryName>Lithium Bromatum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>LITHIUM BROMIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: Take 20 drops on the toungue or in water two to three times daily. Children receive 1/2 of the adult amount.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60986-1020-3</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (60986-1020-3) </PackageDescription>
<NDC11Code>60986-1020-03</NDC11Code>
<ProductNDC>60986-1020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Solidago</ProprietaryName>
<NonProprietaryName>Solidago Virgaurea, Uva-ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Marco Pharma International LLC.</LabelerName>
<SubstanceName>SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; POPULUS TREMULOIDES BARK; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; LARIX DECIDUA RESIN; SODIUM BORATE</SubstanceName>
<StrengthNumber>1; 1; 3; 1; 2; 3; 4; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults: Take 40 drops in tepid water three times daily. For severe symptoms, take 40 drops four to five time daily. After improvement is felt, take 40 drops three times daily. Children receive 1/2 or less of the adult amount.</IndicationAndUsage>
</NDC>
</NDCList>