{
"NDC": [
{
"NDCCode": "68071-2404-2",
"PackageDescription": "2 TABLET, COATED in 1 BOTTLE (68071-2404-2) ",
"NDC11Code": "68071-2404-02",
"ProductNDC": "68071-2404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208921",
"LabelerName": "NuCare 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": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin 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. Skin and Skin Structure Infections ( 1.1). Bone and Joint Infections ( 1.2). Complicated Intra-Abdominal Infections ( 1.3). Infectious Diarrhea ( 1.4). Typhoid Fever (Enteric Fever) ( 1.5). Uncomplicated Cervical and Urethral Gonorrhea ( 1.6). Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7). Plague in adult and pediatric patients ( 1.8). Chronic Bacterial Prostatitis ( 1.9). Lower Respiratory Tract Infections ( 1.10). Acute Exacerbation of Chronic Bronchitis. Urinary Tract Infections ( 1.11). Urinary Tract Infections (UTI). Acute Uncomplicated Cystitis. Complicated UTI and Pyelonephritis in Pediatric Patients. Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).",
"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 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 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG."
},
{
"NDCCode": "68071-2404-4",
"PackageDescription": "4 TABLET, COATED in 1 BOTTLE (68071-2404-4) ",
"NDC11Code": "68071-2404-04",
"ProductNDC": "68071-2404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208921",
"LabelerName": "NuCare 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": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin 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. Skin and Skin Structure Infections ( 1.1). Bone and Joint Infections ( 1.2). Complicated Intra-Abdominal Infections ( 1.3). Infectious Diarrhea ( 1.4). Typhoid Fever (Enteric Fever) ( 1.5). Uncomplicated Cervical and Urethral Gonorrhea ( 1.6). Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7). Plague in adult and pediatric patients ( 1.8). Chronic Bacterial Prostatitis ( 1.9). Lower Respiratory Tract Infections ( 1.10). Acute Exacerbation of Chronic Bronchitis. Urinary Tract Infections ( 1.11). Urinary Tract Infections (UTI). Acute Uncomplicated Cystitis. Complicated UTI and Pyelonephritis in Pediatric Patients. Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).",
"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 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 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG."
},
{
"NDCCode": "68071-2404-6",
"PackageDescription": "6 TABLET, COATED in 1 BOTTLE (68071-2404-6) ",
"NDC11Code": "68071-2404-06",
"ProductNDC": "68071-2404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208921",
"LabelerName": "NuCare 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": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin 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. Skin and Skin Structure Infections ( 1.1). Bone and Joint Infections ( 1.2). Complicated Intra-Abdominal Infections ( 1.3). Infectious Diarrhea ( 1.4). Typhoid Fever (Enteric Fever) ( 1.5). Uncomplicated Cervical and Urethral Gonorrhea ( 1.6). Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7). Plague in adult and pediatric patients ( 1.8). Chronic Bacterial Prostatitis ( 1.9). Lower Respiratory Tract Infections ( 1.10). Acute Exacerbation of Chronic Bronchitis. Urinary Tract Infections ( 1.11). Urinary Tract Infections (UTI). Acute Uncomplicated Cystitis. Complicated UTI and Pyelonephritis in Pediatric Patients. Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).",
"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 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 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG."
},
{
"NDCCode": "22840-2404-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-2404-2) ",
"NDC11Code": "22840-2404-02",
"ProductNDC": "22840-2404",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Bluegum Eucalyptus Pollen",
"NonProprietaryName": "Eucalyptus Globulus",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "EUCALYPTUS GLOBULUS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "36987-2404-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2404-2)",
"NDC11Code": "36987-2404-02",
"ProductNDC": "36987-2404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Velvet Grass",
"NonProprietaryName": "Velvet Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "DISTICHLIS SPICATA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2404-2",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-2404-2) ",
"NDC11Code": "37662-2404-02",
"ProductNDC": "37662-2404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xanthoxylum Fraxineum",
"NonProprietaryName": "Xanthoxylum Fraxineum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ZANTHOXYLUM AMERICANUM BARK",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230118",
"SamplePackage": "N"
},
{
"NDCCode": "57955-2404-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-2404-2)",
"NDC11Code": "57955-2404-02",
"ProductNDC": "57955-2404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aller Detox Outdoor Pollution Control",
"NonProprietaryName": "Benzinum, Calcarea Carbonica, Carbo Vegetabilis, Carboneum Oxygenisatum, Chlorinum, Chloroforum, Chromium Oxydatum, Formalinum, Hekla Lava, Hydrastis Canadensis, Lycopodium Clavatum, Manganum Aceticum, Manganum Carbonicum, Mercurius Vivus, Nitricum Acidum, Phosphoricum Acidum, Phytolacca Decandra, Plumbum Iodatum, Plumbum Metallicum, Sulphur, Taraxacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130610",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BENZENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CARBON MONOXIDE; CHLORINE; CHLOROFORM; CHROMIC OXIDE; FORMALDEHYDE; HEKLA LAVA; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; LEAD IODIDE; LEAD; SULFUR; TARAXACUM OFFICINALE",
"StrengthNumber": "12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for relief of symptoms from outdoor air pollutants: headaches, eye, throat and lung irritation, nausea, breathing difficulties, fatigue, body aches and pains, mild depression."
},
{
"NDCCode": "64942-2404-2",
"PackageDescription": "1 CONTAINER in 1 CARTON (64942-2404-2) / 48 g in 1 CONTAINER (64942-2404-1) ",
"NDC11Code": "64942-2404-02",
"ProductNDC": "64942-2404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dove Clinical Care",
"NonProprietaryName": "Original Clean Soft Solid Antiperspirant Deodorant",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Conopco Inc. d/b/a/ Unilever",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces underarm wetness. Extra effective.",
"Description": "Dove Clinical + Care Original Clean Soft Solid Antiperspirant Deodorant."
},
{
"NDCCode": "70518-2404-2",
"PackageDescription": "30 POUCH in 1 BOX (70518-2404-2) / 1 CAPSULE in 1 POUCH (70518-2404-3) ",
"NDC11Code": "70518-2404-02",
"ProductNDC": "70518-2404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090034",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin Capsules USP for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, crospovidone, D & C Red no. 28, FD & C Blue no. 1, FD & C Red no. 40, gelatin, magnesium stearate, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C 43H 58N 4O 12. The chemical name for rifampin is either:. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "71335-2404-2",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-2404-2) ",
"NDC11Code": "71335-2404-02",
"ProductNDC": "71335-2404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium, Film Coated",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209912",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240613",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.",
"Description": "Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5."
},
{
"NDCCode": "72162-2404-2",
"PackageDescription": "473 mL in 1 BOTTLE (72162-2404-2) ",
"NDC11Code": "72162-2404-02",
"ProductNDC": "72162-2404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "M-pap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "reduces fever. temporarily relieves minor aches and pains due to: Headachemuscular achesbackachearthritisthe common coldtoothachemenstrual crampsreduces fever."
},
{
"NDCCode": "0206-2404-02",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0206-2404-02) > 10 mL in 1 VIAL, SINGLE-USE (0206-2404-01)",
"NDC11Code": "00206-2404-02",
"ProductNDC": "0206-2404",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zosyn",
"NonProprietaryName": "Piperacillin Sodium And Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19931101",
"EndMarketingDate": "20170831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050684",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
"StrengthNumber": ".25; 2",
"StrengthUnit": "g/10mL; g/10mL",
"Pharm_Classes": "beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-09-01"
},
{
"NDCCode": "0456-2404-00",
"PackageDescription": "2565 BLISTER PACK in 1 DRUM (0456-2404-00) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00456-2404-00",
"ProductNDC": "0456-2404",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Asenapine Maleate",
"DosageFormName": "TABLET",
"StartMarketingDate": "20141230",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "ASENAPINE MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "30-DEC-14"
},
{
"NDCCode": "22840-2404-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-2404-4) ",
"NDC11Code": "22840-2404-04",
"ProductNDC": "22840-2404",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Bluegum Eucalyptus Pollen",
"NonProprietaryName": "Eucalyptus Globulus",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "EUCALYPTUS GLOBULUS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "68071-1026-2",
"PackageDescription": "120 TABLET, COATED in 1 BOTTLE (68071-1026-2) ",
"NDC11Code": "68071-1026-02",
"ProductNDC": "68071-1026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076118",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2."
},
{
"NDCCode": "68071-1146-2",
"PackageDescription": "120 TABLET in 1 BOTTLE (68071-1146-2) ",
"NDC11Code": "68071-1146-02",
"ProductNDC": "68071-1146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076820",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170517",
"SamplePackage": "N",
"IndicationAndUsage": "Benazepril hydrochloride (HCl) tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.",
"Description": "Benazepril HCl, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril HCl tablets, USP are supplied as white, round, biconvex tablets containing either 5 mg, 10 mg, 20 mg, or 40 mg of benazepril hydrochloride, USP for oral administration. The inactive ingredients are crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and talc."
},
{
"NDCCode": "68071-1212-2",
"PackageDescription": "270 CAPSULE in 1 BOTTLE (68071-1212-2) ",
"NDC11Code": "68071-1212-02",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1230-2",
"PackageDescription": "28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-1230-2) ",
"NDC11Code": "68071-1230-02",
"ProductNDC": "68071-1230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141031",
"EndMarketingDate": "20180801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091672",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180222",
"EndMarketingDatePackage": "20180801",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1292-2",
"PackageDescription": "120 TABLET in 1 BOTTLE (68071-1292-2) ",
"NDC11Code": "68071-1292-02",
"ProductNDC": "68071-1292",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077662",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170222",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets USP are indicated for: 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
"Description": "The active ingredient in gabapentin tablets USP is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water."
},
{
"NDCCode": "68071-1392-2",
"PackageDescription": "2 TABLET, FILM COATED in 1 BOTTLE (68071-1392-2)",
"NDC11Code": "68071-1392-02",
"ProductNDC": "68071-1392",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065153",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-08",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68071-1419-2",
"PackageDescription": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2) ",
"NDC11Code": "68071-1419-02",
"ProductNDC": "68071-1419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201991",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170329",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended release tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended release tablets USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-dimethylimidodicar- bonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended release tablets USP contain 500 mg of metformin hydrochloride USP as the active ingredient. Metformin hydrochloride extended release tablets USP 500 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose and magnesium stearate. Metformin hydrochloride extended release tablets USP 500 mg meets USP dissolution Test 3. System Components and Performance- Metformin hydrochloride extended release tablets USP comprises a swellable matrix system. In the aqueous gastrointestinal (GI) environment, the dosage form swells remarkably thereby increasing in size and geometry from where drug is released slowly by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "68071-1550-6",
"PackageDescription": "2.5 mL in 1 VIAL (68071-1550-6) ",
"NDC11Code": "68071-1550-06",
"ProductNDC": "68071-1550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171227",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1598-2",
"PackageDescription": "1 TUBE in 1 CARTON (68071-1598-2) / 20 g in 1 TUBE",
"NDC11Code": "68071-1598-02",
"ProductNDC": "68071-1598",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085027",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230419",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.",
"Description": "Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C 21H 3O0 5) and is represented by the following structural formula:. Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "68071-1616-3",
"PackageDescription": "2.5 mL in 1 BOX (68071-1616-3) ",
"NDC11Code": "68071-1616-03",
"ProductNDC": "68071-1616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20080320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077689",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170712",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1626-2",
"PackageDescription": "20 g in 1 BOX (68071-1626-2) ",
"NDC11Code": "68071-1626-02",
"ProductNDC": "68071-1626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terconazole",
"NonProprietaryName": "Terconazole",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "20040406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075953",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "TERCONAZOLE",
"StrengthNumber": "8",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180724",
"SamplePackage": "N",
"IndicationAndUsage": "Terconazole vaginal cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.",
"Description": "Terconazole Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[ p-[[2-(2,4-Dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, and stearyl alcohol. The structural formula of terconazole is as follows. Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol."
},
{
"NDCCode": "68071-1637-2",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (68071-1637-2) ",
"NDC11Code": "68071-1637-02",
"ProductNDC": "68071-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065496",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1) : 1 Acute bacterial otitis media (pediatric patients) ( 1.2) , 2 Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3) , 3 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4) , 4 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5) , 5 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6) , 6 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) ( 1.7) , 7 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 (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": "68071-1670-2",
"PackageDescription": "200 AEROSOL, METERED in 1 BOX (68071-1670-2) ",
"NDC11Code": "68071-1670-02",
"ProductNDC": "68071-1670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ventolin",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20060609",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020983",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170721",
"SamplePackage": "N",
"IndicationAndUsage": "VENTOLIN HFA is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in patients aged 4 years and older. (1.2) .",
"Description": "The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure:. Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. VENTOLIN HFA is a blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray."
},
{
"NDCCode": "68071-1683-2",
"PackageDescription": "2.5 mL in 1 BOTTLE (68071-1683-2)",
"NDC11Code": "68071-1683-02",
"ProductNDC": "68071-1683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Latanoprost",
"NonProprietaryName": "Latanoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20110322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201006",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "LATANOPROST",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC],Prostaglandins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68071-1737-2",
"PackageDescription": "2.5 mL in 1 VIAL (68071-1737-2) ",
"NDC11Code": "68071-1737-02",
"ProductNDC": "68071-1737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180813",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.",
"Description": "The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, ( +)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C 20H 30BrNO 3H 2O Mol.Wt. 430.4. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid."
},
{
"NDCCode": "68071-1762-2",
"PackageDescription": "120 TABLET in 1 BOTTLE (68071-1762-2)",
"NDC11Code": "68071-1762-02",
"ProductNDC": "68071-1762",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspir Low",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110524",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "Y",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68071-2404-2</NDCCode>
<PackageDescription>2 TABLET, COATED in 1 BOTTLE (68071-2404-2) </PackageDescription>
<NDC11Code>68071-2404-02</NDC11Code>
<ProductNDC>68071-2404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208921</ApplicationNumber>
<LabelerName>NuCare 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>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin 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. Skin and Skin Structure Infections ( 1.1). Bone and Joint Infections ( 1.2). Complicated Intra-Abdominal Infections ( 1.3). Infectious Diarrhea ( 1.4). Typhoid Fever (Enteric Fever) ( 1.5). Uncomplicated Cervical and Urethral Gonorrhea ( 1.6). Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7). Plague in adult and pediatric patients ( 1.8). Chronic Bacterial Prostatitis ( 1.9). Lower Respiratory Tract Infections ( 1.10). Acute Exacerbation of Chronic Bronchitis. Urinary Tract Infections ( 1.11). Urinary Tract Infections (UTI). Acute Uncomplicated Cystitis. Complicated UTI and Pyelonephritis in Pediatric Patients. Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).</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 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 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
</NDC>
<NDC>
<NDCCode>68071-2404-4</NDCCode>
<PackageDescription>4 TABLET, COATED in 1 BOTTLE (68071-2404-4) </PackageDescription>
<NDC11Code>68071-2404-04</NDC11Code>
<ProductNDC>68071-2404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208921</ApplicationNumber>
<LabelerName>NuCare 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>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin 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. Skin and Skin Structure Infections ( 1.1). Bone and Joint Infections ( 1.2). Complicated Intra-Abdominal Infections ( 1.3). Infectious Diarrhea ( 1.4). Typhoid Fever (Enteric Fever) ( 1.5). Uncomplicated Cervical and Urethral Gonorrhea ( 1.6). Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7). Plague in adult and pediatric patients ( 1.8). Chronic Bacterial Prostatitis ( 1.9). Lower Respiratory Tract Infections ( 1.10). Acute Exacerbation of Chronic Bronchitis. Urinary Tract Infections ( 1.11). Urinary Tract Infections (UTI). Acute Uncomplicated Cystitis. Complicated UTI and Pyelonephritis in Pediatric Patients. Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).</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 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 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
</NDC>
<NDC>
<NDCCode>68071-2404-6</NDCCode>
<PackageDescription>6 TABLET, COATED in 1 BOTTLE (68071-2404-6) </PackageDescription>
<NDC11Code>68071-2404-06</NDC11Code>
<ProductNDC>68071-2404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208921</ApplicationNumber>
<LabelerName>NuCare 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>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin 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. Skin and Skin Structure Infections ( 1.1). Bone and Joint Infections ( 1.2). Complicated Intra-Abdominal Infections ( 1.3). Infectious Diarrhea ( 1.4). Typhoid Fever (Enteric Fever) ( 1.5). Uncomplicated Cervical and Urethral Gonorrhea ( 1.6). Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7). Plague in adult and pediatric patients ( 1.8). Chronic Bacterial Prostatitis ( 1.9). Lower Respiratory Tract Infections ( 1.10). Acute Exacerbation of Chronic Bronchitis. Urinary Tract Infections ( 1.11). Urinary Tract Infections (UTI). Acute Uncomplicated Cystitis. Complicated UTI and Pyelonephritis in Pediatric Patients. Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).</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 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 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
</NDC>
<NDC>
<NDCCode>22840-2404-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-2404-2) </PackageDescription>
<NDC11Code>22840-2404-02</NDC11Code>
<ProductNDC>22840-2404</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Bluegum Eucalyptus Pollen</ProprietaryName>
<NonProprietaryName>Eucalyptus Globulus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>EUCALYPTUS GLOBULUS POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>36987-2404-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2404-2)</PackageDescription>
<NDC11Code>36987-2404-02</NDC11Code>
<ProductNDC>36987-2404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Velvet Grass</ProprietaryName>
<NonProprietaryName>Velvet Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>DISTICHLIS SPICATA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2404-2</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-2404-2) </PackageDescription>
<NDC11Code>37662-2404-02</NDC11Code>
<ProductNDC>37662-2404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xanthoxylum Fraxineum</ProprietaryName>
<NonProprietaryName>Xanthoxylum Fraxineum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ZANTHOXYLUM AMERICANUM BARK</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57955-2404-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-2404-2)</PackageDescription>
<NDC11Code>57955-2404-02</NDC11Code>
<ProductNDC>57955-2404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aller Detox Outdoor Pollution Control</ProprietaryName>
<NonProprietaryName>Benzinum, Calcarea Carbonica, Carbo Vegetabilis, Carboneum Oxygenisatum, Chlorinum, Chloroforum, Chromium Oxydatum, Formalinum, Hekla Lava, Hydrastis Canadensis, Lycopodium Clavatum, Manganum Aceticum, Manganum Carbonicum, Mercurius Vivus, Nitricum Acidum, Phosphoricum Acidum, Phytolacca Decandra, Plumbum Iodatum, Plumbum Metallicum, Sulphur, Taraxacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BENZENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CARBON MONOXIDE; CHLORINE; CHLOROFORM; CHROMIC OXIDE; FORMALDEHYDE; HEKLA LAVA; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; LEAD IODIDE; LEAD; SULFUR; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for relief of symptoms from outdoor air pollutants: headaches, eye, throat and lung irritation, nausea, breathing difficulties, fatigue, body aches and pains, mild depression.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64942-2404-2</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (64942-2404-2) / 48 g in 1 CONTAINER (64942-2404-1) </PackageDescription>
<NDC11Code>64942-2404-02</NDC11Code>
<ProductNDC>64942-2404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dove Clinical Care</ProprietaryName>
<NonProprietaryName>Original Clean Soft Solid Antiperspirant Deodorant</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces underarm wetness. Extra effective.</IndicationAndUsage>
<Description>Dove Clinical + Care Original Clean Soft Solid Antiperspirant Deodorant.</Description>
</NDC>
<NDC>
<NDCCode>70518-2404-2</NDCCode>
<PackageDescription>30 POUCH in 1 BOX (70518-2404-2) / 1 CAPSULE in 1 POUCH (70518-2404-3) </PackageDescription>
<NDC11Code>70518-2404-02</NDC11Code>
<ProductNDC>70518-2404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090034</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin Capsules USP for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, crospovidone, D & C Red no. 28, FD & C Blue no. 1, FD & C Red no. 40, gelatin, magnesium stearate, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C 43H 58N 4O 12. The chemical name for rifampin is either:. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>71335-2404-2</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-2404-2) </PackageDescription>
<NDC11Code>71335-2404-02</NDC11Code>
<ProductNDC>71335-2404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium, Film Coated</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209912</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of. ○ Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. ○ MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. ○ Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in. ○ Adults with primary hyperlipidemia. ○ Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with. ○ Primary dysbetalipoproteinemia. ○ Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium USP is [R-(R*, R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Atorvastatin Calcium Tablets, USP meets the requirements of USP dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>72162-2404-2</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (72162-2404-2) </PackageDescription>
<NDC11Code>72162-2404-02</NDC11Code>
<ProductNDC>72162-2404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>M-pap</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces fever. temporarily relieves minor aches and pains due to: Headachemuscular achesbackachearthritisthe common coldtoothachemenstrual crampsreduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0206-2404-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0206-2404-02) > 10 mL in 1 VIAL, SINGLE-USE (0206-2404-01)</PackageDescription>
<NDC11Code>00206-2404-02</NDC11Code>
<ProductNDC>0206-2404</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zosyn</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium And Tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19931101</StartMarketingDate>
<EndMarketingDate>20170831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050684</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
<StrengthNumber>.25; 2</StrengthNumber>
<StrengthUnit>g/10mL; g/10mL</StrengthUnit>
<Pharm_Classes>beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>0456-2404-00</NDCCode>
<PackageDescription>2565 BLISTER PACK in 1 DRUM (0456-2404-00) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00456-2404-00</NDC11Code>
<ProductNDC>0456-2404</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Asenapine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20141230</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>ASENAPINE MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-DEC-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>22840-2404-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-2404-4) </PackageDescription>
<NDC11Code>22840-2404-04</NDC11Code>
<ProductNDC>22840-2404</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Bluegum Eucalyptus Pollen</ProprietaryName>
<NonProprietaryName>Eucalyptus Globulus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>EUCALYPTUS GLOBULUS POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>68071-1026-2</NDCCode>
<PackageDescription>120 TABLET, COATED in 1 BOTTLE (68071-1026-2) </PackageDescription>
<NDC11Code>68071-1026-02</NDC11Code>
<ProductNDC>68071-1026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076118</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril hydrochloride is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68071-1146-2</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (68071-1146-2) </PackageDescription>
<NDC11Code>68071-1146-02</NDC11Code>
<ProductNDC>68071-1146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076820</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benazepril hydrochloride (HCl) tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Benazepril HCl, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril HCl tablets, USP are supplied as white, round, biconvex tablets containing either 5 mg, 10 mg, 20 mg, or 40 mg of benazepril hydrochloride, USP for oral administration. The inactive ingredients are crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and talc.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-2</NDCCode>
<PackageDescription>270 CAPSULE in 1 BOTTLE (68071-1212-2) </PackageDescription>
<NDC11Code>68071-1212-02</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1230-2</NDCCode>
<PackageDescription>28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-1230-2) </PackageDescription>
<NDC11Code>68071-1230-02</NDC11Code>
<ProductNDC>68071-1230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<EndMarketingDate>20180801</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091672</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180222</StartMarketingDatePackage>
<EndMarketingDatePackage>20180801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-1292-2</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (68071-1292-2) </PackageDescription>
<NDC11Code>68071-1292-02</NDC11Code>
<ProductNDC>68071-1292</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077662</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets USP are indicated for: 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets USP is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68071-1392-2</NDCCode>
<PackageDescription>2 TABLET, FILM COATED in 1 BOTTLE (68071-1392-2)</PackageDescription>
<NDC11Code>68071-1392-02</NDC11Code>
<ProductNDC>68071-1392</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065153</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-08</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68071-1419-2</NDCCode>
<PackageDescription>20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2) </PackageDescription>
<NDC11Code>68071-1419-02</NDC11Code>
<ProductNDC>68071-1419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201991</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended release tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended release tablets USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N-dimethylimidodicar- bonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended release tablets USP contain 500 mg of metformin hydrochloride USP as the active ingredient. Metformin hydrochloride extended release tablets USP 500 mg contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose and magnesium stearate. Metformin hydrochloride extended release tablets USP 500 mg meets USP dissolution Test 3. System Components and Performance- Metformin hydrochloride extended release tablets USP comprises a swellable matrix system. In the aqueous gastrointestinal (GI) environment, the dosage form swells remarkably thereby increasing in size and geometry from where drug is released slowly by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>68071-1550-6</NDCCode>
<PackageDescription>2.5 mL in 1 VIAL (68071-1550-6) </PackageDescription>
<NDC11Code>68071-1550-06</NDC11Code>
<ProductNDC>68071-1550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-1598-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68071-1598-2) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>68071-1598-02</NDC11Code>
<ProductNDC>68071-1598</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085027</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.</IndicationAndUsage>
<Description>Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the molecular formula (C 21H 3O0 5) and is represented by the following structural formula:. Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>68071-1616-3</NDCCode>
<PackageDescription>2.5 mL in 1 BOX (68071-1616-3) </PackageDescription>
<NDC11Code>68071-1616-03</NDC11Code>
<ProductNDC>68071-1616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20080320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077689</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-1626-2</NDCCode>
<PackageDescription>20 g in 1 BOX (68071-1626-2) </PackageDescription>
<NDC11Code>68071-1626-02</NDC11Code>
<ProductNDC>68071-1626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terconazole</ProprietaryName>
<NonProprietaryName>Terconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20040406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075953</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>TERCONAZOLE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terconazole vaginal cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.</IndicationAndUsage>
<Description>Terconazole Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[ p-[[2-(2,4-Dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, and stearyl alcohol. The structural formula of terconazole is as follows. Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.</Description>
</NDC>
<NDC>
<NDCCode>68071-1637-2</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (68071-1637-2) </PackageDescription>
<NDC11Code>68071-1637-02</NDC11Code>
<ProductNDC>68071-1637</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>NuCare 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>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</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: Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1) : 1 Acute bacterial otitis media (pediatric patients) ( 1.2) , 2 Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3) , 3 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4) , 4 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5) , 5 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6) , 6 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) ( 1.7) , 7 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 (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>68071-1670-2</NDCCode>
<PackageDescription>200 AEROSOL, METERED in 1 BOX (68071-1670-2) </PackageDescription>
<NDC11Code>68071-1670-02</NDC11Code>
<ProductNDC>68071-1670</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ventolin</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20060609</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020983</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VENTOLIN HFA is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in patients aged 4 years and older. (1.2) .</IndicationAndUsage>
<Description>The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure:. Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. VENTOLIN HFA is a blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister fitted with a counter. Each canister contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients. After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray.</Description>
</NDC>
<NDC>
<NDCCode>68071-1683-2</NDCCode>
<PackageDescription>2.5 mL in 1 BOTTLE (68071-1683-2)</PackageDescription>
<NDC11Code>68071-1683-02</NDC11Code>
<ProductNDC>68071-1683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Latanoprost</ProprietaryName>
<NonProprietaryName>Latanoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20110322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201006</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>LATANOPROST</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC],Prostaglandins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68071-1737-2</NDCCode>
<PackageDescription>2.5 mL in 1 VIAL (68071-1737-2) </PackageDescription>
<NDC11Code>68071-1737-02</NDC11Code>
<ProductNDC>68071-1737</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.</IndicationAndUsage>
<Description>The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, ( +)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C 20H 30BrNO 3H 2O Mol.Wt. 430.4. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>68071-1762-2</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (68071-1762-2)</PackageDescription>
<NDC11Code>68071-1762-02</NDC11Code>
<ProductNDC>68071-1762</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspir Low</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>Y</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>