{
"NDC": [
{
"NDCCode": "72789-302-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-302-20) ",
"NDC11Code": "72789-0302-20",
"ProductNDC": "72789-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230814",
"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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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": "72789-302-06",
"PackageDescription": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-302-06) ",
"NDC11Code": "72789-0302-06",
"ProductNDC": "72789-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230327",
"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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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": "72789-302-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-302-10) ",
"NDC11Code": "72789-0302-10",
"ProductNDC": "72789-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230301",
"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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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": "72789-302-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-302-12) ",
"NDC11Code": "72789-0302-12",
"ProductNDC": "72789-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230410",
"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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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": "72789-302-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-302-14) ",
"NDC11Code": "72789-0302-14",
"ProductNDC": "72789-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230516",
"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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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": "17089-302-20",
"PackageDescription": "2 TUBE in 1 BOX (17089-302-20) > 4 g in 1 TUBE",
"NDC11Code": "17089-0302-20",
"ProductNDC": "17089-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-stomach",
"NonProprietaryName": "Activated Charcoal - Antimony Trisulfide - Bismuth Subnitrate - Dioscorea Villosa Root - Dopamine - Human Epidermal Growth Factor - Ipecac - Oregano - Picea Mariana Resin - Robinia Pseudoacacia Bark - Semecarpus Anacardium Juice - Silver Nitrate - Sus Scrofa Stomach - Sus Scrofa Sympathetic Nerve - Momordica Balsamina Immature Fruit -",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180515",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "PICEA MARIANA RESIN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; IPECAC; DIOSCOREA VILLOSA ROOT; DOPAMINE; HUMAN EPIDERMAL GROWTH FACTOR; MOMORDICA BALSAMINA IMMATURE FRUIT; OREGANO; ROBINIA PSEUDOACACIA BARK; SUS SCROFA STOMACH; SUS SCROFA SYMPATHETIC NERVE",
"StrengthNumber": "3; 30; 30; 30; 6; 6; 30; 3; 6; 4; 3; 10; 2; 30; 6",
"StrengthUnit": "[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g",
"Pharm_Classes": "Allergens [CS], Bismuth [CS], Bismuth [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180515",
"SamplePackage": "N",
"IndicationAndUsage": "Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals."
},
{
"NDCCode": "43063-302-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (43063-302-20)",
"NDC11Code": "43063-0302-20",
"ProductNDC": "43063-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040245",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55037-302-20",
"PackageDescription": "7300 L in 1 CYLINDER (55037-302-20) ",
"NDC11Code": "55037-0302-20",
"ProductNDC": "55037-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Air",
"NonProprietaryName": "Air",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19870101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205890",
"LabelerName": "Matheson Tri-Gas, Inc.",
"SubstanceName": "AIR",
"StrengthNumber": "1000",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870101",
"SamplePackage": "N"
},
{
"NDCCode": "57297-302-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (57297-302-20) ",
"NDC11Code": "57297-0302-20",
"ProductNDC": "57297-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030725",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065135",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030725",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime axetil tablets USP are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).",
"Description": "Cefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1- azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime axetil tablets USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets USP contain the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, propylene glycol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "58602-302-20",
"PackageDescription": "236 mL in 1 BOTTLE (58602-302-20) ",
"NDC11Code": "58602-0302-20",
"ProductNDC": "58602-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stomach Relief",
"NonProprietaryName": "Stomach Relief",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170401",
"EndMarketingDate": "20220901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2022-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170401",
"EndMarketingDatePackage": "20220901",
"SamplePackage": "N"
},
{
"NDCCode": "63541-302-10",
"PackageDescription": "1 BAG in 1 BOX (63541-302-10) > 20 kg in 1 BAG",
"NDC11Code": "63541-0302-10",
"ProductNDC": "63541-302",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oxybenzone",
"DosageFormName": "CRYSTAL",
"StartMarketingDate": "20130110",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "3V Inc.",
"SubstanceName": "OXYBENZONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "65841-302-04",
"PackageDescription": "1 POUCH in 1 DRUM (65841-302-04) / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 20 kg in 1 BAG",
"NDC11Code": "65841-0302-04",
"ProductNDC": "65841-302",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Phenylbutazone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250927",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PHENYLBUTAZONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-09-30",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "27-SEP-25"
},
{
"NDCCode": "68180-302-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (68180-302-20) ",
"NDC11Code": "68180-0302-20",
"ProductNDC": "68180-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081008",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065135",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081008",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).",
"Description": "Cefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1- azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime axetil tablets USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets USP contain the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, propylene glycol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "70934-302-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (70934-302-20) ",
"NDC11Code": "70934-0302-20",
"ProductNDC": "70934-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190304",
"EndMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076817",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190304",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "N"
},
{
"NDCCode": "70979-302-01",
"PackageDescription": "20 kg in 1 BOX (70979-302-01) ",
"NDC11Code": "70979-0302-01",
"ProductNDC": "70979-302",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "K.S.PEARL CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "15.52",
"StrengthUnit": "kg/20kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-DEC-17"
},
{
"NDCCode": "74166-302-20",
"PackageDescription": "20 CLOTH in 1 POUCH (74166-302-20) ",
"NDC11Code": "74166-0302-20",
"ProductNDC": "74166-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sooae Hand Santizing Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200430",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "DKCOS CORP",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200430",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N"
},
{
"NDCCode": "76485-1060-1",
"PackageDescription": "30 mL in 1 BOTTLE (76485-1060-1) ",
"NDC11Code": "76485-1060-01",
"ProductNDC": "76485-1060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Match Perfection Foundation Spf 20 - Shade 302",
"ProprietaryNameSuffix": "Golden Honey ",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Rimmel Inc.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.278; 2.374",
"StrengthUnit": "g/30mL; g/30mL",
"Status": "Deprecated",
"LastUpdate": "2020-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N"
},
{
"NDCCode": "80159-302-03",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (80159-302-03) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "80159-0302-03",
"ProductNDC": "80159-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Picnic Nasal Decongestant",
"NonProprietaryName": "Pseudoephedrine Hcl",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075153",
"LabelerName": "30M One, Inc.",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220208",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "81362-302-20",
"PackageDescription": "220 CAPSULE, GELATIN COATED in 1 BOTTLE (81362-302-20) ",
"NDC11Code": "81362-0302-20",
"ProductNDC": "81362-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Simethicone Antigas",
"ProprietaryNameSuffix": "125 Mg",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210405",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "LLS HEALTH LLC",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210405",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief of pressure, bloating, and fullness, commonly referred to as gas."
},
{
"NDCCode": "82393-302-16",
"PackageDescription": "20 kg in 1 DRUM (82393-302-16) ",
"NDC11Code": "82393-0302-16",
"ProductNDC": "82393-302",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pharma Source Direct, Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-05-21",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-MAY-24"
},
{
"NDCCode": "85786-302-40",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (85786-302-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "85786-0302-40",
"ProductNDC": "85786-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr. Simi Mucus Relief",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213420",
"LabelerName": "Farmacias De Similares TX LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260408",
"SamplePackage": "N",
"IndicationAndUsage": "â– helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "72789-012-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-012-20) ",
"NDC11Code": "72789-0012-20",
"ProductNDC": "72789-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190920",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "72789-018-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (72789-018-20) ",
"NDC11Code": "72789-0018-20",
"ProductNDC": "72789-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191017",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "72789-035-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-20) ",
"NDC11Code": "72789-0035-20",
"ProductNDC": "72789-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065496",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191218",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.",
"Description": "Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is ( RS)-1 hydroxyethyl (6 R,7 R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1 azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-( Z)-( O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C 20H 22N 4O 10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime axetil tablets, USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets, USP contain the inactive ingredients microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, colloidal silicon dioxide, calcium stearate, calcium carbonate, crospovidone, hypromellose, titanium dioxide, propylene glycol, FD &C blue no.1 Aluminium lake."
},
{
"NDCCode": "72789-041-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-041-20) ",
"NDC11Code": "72789-0041-20",
"ProductNDC": "72789-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200213",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "72789-046-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-20) ",
"NDC11Code": "72789-0046-20",
"ProductNDC": "72789-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077797",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine Hydrochloride Tablets, USP are supplied as 5 mg and 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40 and 10 mg tablets contain D&C Yellow #10 and polysorbate."
},
{
"NDCCode": "72789-054-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (72789-054-20) ",
"NDC11Code": "72789-0054-20",
"ProductNDC": "72789-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065434",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CEFDINIR",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200221",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules, USP are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir capsules, USP contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir USP is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C 14H 13N 5O 5S 2and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules, USP contain 300 mg cefdinir USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "72789-061-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (72789-061-20) ",
"NDC11Code": "72789-0061-20",
"ProductNDC": "72789-061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefdinir",
"NonProprietaryName": "Cefdinir",
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"RouteName": "ORAL",
"StartMarketingDate": "20080107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065434",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CEFDINIR",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-03",
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"StartMarketingDatePackage": "20200311",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules, USP are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefdinir capsules, USP contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir USP is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C 14H 13N 5O 5S 2and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules, USP contain 300 mg cefdinir USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac."
},
{
"NDCCode": "72789-064-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (72789-064-20) ",
"NDC11Code": "72789-0064-20",
"ProductNDC": "72789-064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200323",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "72789-065-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-065-20) ",
"NDC11Code": "72789-0065-20",
"ProductNDC": "72789-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076126",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-05-01",
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"StartMarketingDatePackage": "20200323",
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"IndicationAndUsage": "Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone antibacterial indicated in adults (≥18 years of age) 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 (Ciprofloxacin hydrochloride) Tablets 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 empirical formula is C 17H 18FN 3O 3HClH 2O 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 empirical formula is C 17H 18FN 3O 3and 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. Ciprofloxacin tablets are white to slightly yellowish. The inactive ingredients are Lactose Monohydrate, Magnesium Stearate, Sodium Starch Gylcolate, and Starch 1500 (Modified Corn Starch)."
}
]
}
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<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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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>
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<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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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>
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<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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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>
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<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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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>72789-302-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-302-14) </PackageDescription>
<NDC11Code>72789-0302-14</NDC11Code>
<ProductNDC>72789-302</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>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230516</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 C 17H 18FN 3O 3HClH 2O 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 C 17H 18FN 3O 3and 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>17089-302-20</NDCCode>
<PackageDescription>2 TUBE in 1 BOX (17089-302-20) > 4 g in 1 TUBE</PackageDescription>
<NDC11Code>17089-0302-20</NDC11Code>
<ProductNDC>17089-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-stomach</ProprietaryName>
<NonProprietaryName>Activated Charcoal - Antimony Trisulfide - Bismuth Subnitrate - Dioscorea Villosa Root - Dopamine - Human Epidermal Growth Factor - Ipecac - Oregano - Picea Mariana Resin - Robinia Pseudoacacia Bark - Semecarpus Anacardium Juice - Silver Nitrate - Sus Scrofa Stomach - Sus Scrofa Sympathetic Nerve - Momordica Balsamina Immature Fruit -</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180515</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>PICEA MARIANA RESIN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; IPECAC; DIOSCOREA VILLOSA ROOT; DOPAMINE; HUMAN EPIDERMAL GROWTH FACTOR; MOMORDICA BALSAMINA IMMATURE FRUIT; OREGANO; ROBINIA PSEUDOACACIA BARK; SUS SCROFA STOMACH; SUS SCROFA SYMPATHETIC NERVE</SubstanceName>
<StrengthNumber>3; 30; 30; 30; 6; 6; 30; 3; 6; 4; 3; 10; 2; 30; 6</StrengthNumber>
<StrengthUnit>[hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bismuth [CS], Bismuth [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve. Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-302-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (43063-302-20)</PackageDescription>
<NDC11Code>43063-0302-20</NDC11Code>
<ProductNDC>43063-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040245</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55037-302-20</NDCCode>
<PackageDescription>7300 L in 1 CYLINDER (55037-302-20) </PackageDescription>
<NDC11Code>55037-0302-20</NDC11Code>
<ProductNDC>55037-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19870101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205890</ApplicationNumber>
<LabelerName>Matheson Tri-Gas, Inc.</LabelerName>
<SubstanceName>AIR</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57297-302-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (57297-302-20) </PackageDescription>
<NDC11Code>57297-0302-20</NDC11Code>
<ProductNDC>57297-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Axetil</ProprietaryName>
<NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030725</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065135</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>CEFUROXIME AXETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030725</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime axetil tablets USP are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).</IndicationAndUsage>
<Description>Cefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1- azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime axetil tablets USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets USP contain the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, propylene glycol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>58602-302-20</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (58602-302-20) </PackageDescription>
<NDC11Code>58602-0302-20</NDC11Code>
<ProductNDC>58602-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stomach Relief</ProprietaryName>
<NonProprietaryName>Stomach Relief</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170401</StartMarketingDate>
<EndMarketingDate>20220901</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>525</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170401</StartMarketingDatePackage>
<EndMarketingDatePackage>20220901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63541-302-10</NDCCode>
<PackageDescription>1 BAG in 1 BOX (63541-302-10) > 20 kg in 1 BAG</PackageDescription>
<NDC11Code>63541-0302-10</NDC11Code>
<ProductNDC>63541-302</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxybenzone</NonProprietaryName>
<DosageFormName>CRYSTAL</DosageFormName>
<StartMarketingDate>20130110</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>3V Inc.</LabelerName>
<SubstanceName>OXYBENZONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65841-302-04</NDCCode>
<PackageDescription>1 POUCH in 1 DRUM (65841-302-04) / 1 BAG in 1 POUCH / 1 BAG in 1 BAG / 20 kg in 1 BAG</PackageDescription>
<NDC11Code>65841-0302-04</NDC11Code>
<ProductNDC>65841-302</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Phenylbutazone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250927</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PHENYLBUTAZONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-30</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-SEP-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68180-302-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (68180-302-20) </PackageDescription>
<NDC11Code>68180-0302-20</NDC11Code>
<ProductNDC>68180-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Axetil</ProprietaryName>
<NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081008</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065135</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEFUROXIME AXETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081008</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1): 1 Pharyngitis/tonsillitis (adults and pediatric patients) (1.1), 2 Acute bacterial otitis media (pediatric patients) (1.2), 3 Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3), 4 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4), 5 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5), 6 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6), 7 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7), 8 Early Lyme disease (adults and pediatric patients 13 years and older) (1.8).</IndicationAndUsage>
<Description>Cefuroxime axetil tablets USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1- azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime axetil tablets USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets USP contain the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, propylene glycol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70934-302-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (70934-302-20) </PackageDescription>
<NDC11Code>70934-0302-20</NDC11Code>
<ProductNDC>70934-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190304</StartMarketingDate>
<EndMarketingDate>20230228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076817</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70979-302-01</NDCCode>
<PackageDescription>20 kg in 1 BOX (70979-302-01) </PackageDescription>
<NDC11Code>70979-0302-01</NDC11Code>
<ProductNDC>70979-302</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>K.S.PEARL CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>15.52</StrengthNumber>
<StrengthUnit>kg/20kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-DEC-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>74166-302-20</NDCCode>
<PackageDescription>20 CLOTH in 1 POUCH (74166-302-20) </PackageDescription>
<NDC11Code>74166-0302-20</NDC11Code>
<ProductNDC>74166-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sooae Hand Santizing Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200430</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>DKCOS CORP</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76485-1060-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (76485-1060-1) </PackageDescription>
<NDC11Code>76485-1060-01</NDC11Code>
<ProductNDC>76485-1060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Match Perfection Foundation Spf 20 - Shade 302</ProprietaryName>
<ProprietaryNameSuffix>Golden Honey </ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Rimmel Inc.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.278; 2.374</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80159-302-03</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (80159-302-03) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>80159-0302-03</NDC11Code>
<ProductNDC>80159-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Picnic Nasal Decongestant</ProprietaryName>
<NonProprietaryName>Pseudoephedrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075153</ApplicationNumber>
<LabelerName>30M One, Inc.</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81362-302-20</NDCCode>
<PackageDescription>220 CAPSULE, GELATIN COATED in 1 BOTTLE (81362-302-20) </PackageDescription>
<NDC11Code>81362-0302-20</NDC11Code>
<ProductNDC>81362-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Simethicone Antigas</ProprietaryName>
<ProprietaryNameSuffix>125 Mg</ProprietaryNameSuffix>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>LLS HEALTH LLC</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief of pressure, bloating, and fullness, commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82393-302-16</NDCCode>
<PackageDescription>20 kg in 1 DRUM (82393-302-16) </PackageDescription>
<NDC11Code>82393-0302-16</NDC11Code>
<ProductNDC>82393-302</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pharma Source Direct, Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-05-21</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>85786-302-40</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (85786-302-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>85786-0302-40</NDC11Code>
<ProductNDC>85786-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr. Simi Mucus Relief</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213420</ApplicationNumber>
<LabelerName>Farmacias De Similares TX LLC</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>â– helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72789-012-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-012-20) </PackageDescription>
<NDC11Code>72789-0012-20</NDC11Code>
<ProductNDC>72789-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>72789-018-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (72789-018-20) </PackageDescription>
<NDC11Code>72789-0018-20</NDC11Code>
<ProductNDC>72789-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>72789-035-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-20) </PackageDescription>
<NDC11Code>72789-0035-20</NDC11Code>
<ProductNDC>72789-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Axetil</ProprietaryName>
<NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065496</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEFUROXIME AXETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.</IndicationAndUsage>
<Description>Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is ( RS)-1 hydroxyethyl (6 R,7 R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1 azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-( Z)-( O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C 20H 22N 4O 10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime axetil tablets, USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets, USP contain the inactive ingredients microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, colloidal silicon dioxide, calcium stearate, calcium carbonate, crospovidone, hypromellose, titanium dioxide, propylene glycol, FD &C blue no.1 Aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>72789-041-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-041-20) </PackageDescription>
<NDC11Code>72789-0041-20</NDC11Code>
<ProductNDC>72789-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>72789-046-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-20) </PackageDescription>
<NDC11Code>72789-0046-20</NDC11Code>
<ProductNDC>72789-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077797</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine Hydrochloride Tablets, USP are supplied as 5 mg and 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40 and 10 mg tablets contain D&C Yellow #10 and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>72789-054-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (72789-054-20) </PackageDescription>
<NDC11Code>72789-0054-20</NDC11Code>
<ProductNDC>72789-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065434</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEFDINIR</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules, USP are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir capsules, USP contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir USP is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C 14H 13N 5O 5S 2and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules, USP contain 300 mg cefdinir USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72789-061-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (72789-061-20) </PackageDescription>
<NDC11Code>72789-0061-20</NDC11Code>
<ProductNDC>72789-061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefdinir</ProprietaryName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065434</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEFDINIR</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules, USP are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefdinir capsules, USP contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir USP is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C 14H 13N 5O 5S 2and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules, USP contain 300 mg cefdinir USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72789-064-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (72789-064-20) </PackageDescription>
<NDC11Code>72789-0064-20</NDC11Code>
<ProductNDC>72789-064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>72789-065-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-065-20) </PackageDescription>
<NDC11Code>72789-0065-20</NDC11Code>
<ProductNDC>72789-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076126</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone antibacterial indicated in adults (≥18 years of age) 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 (Ciprofloxacin hydrochloride) Tablets 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 empirical formula is C 17H 18FN 3O 3HClH 2O 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 empirical formula is C 17H 18FN 3O 3and 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. Ciprofloxacin tablets are white to slightly yellowish. The inactive ingredients are Lactose Monohydrate, Magnesium Stearate, Sodium Starch Gylcolate, and Starch 1500 (Modified Corn Starch).</Description>
</NDC>
</NDCList>