{
"NDC": [
{
"NDCCode": "63304-768-04",
"PackageDescription": "100 mL in 1 BOTTLE (63304-768-04)",
"NDC11Code": "63304-0768-04",
"ProductNDC": "63304-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065207",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49967-768-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (49967-768-04) > 75 mL in 1 BOTTLE",
"NDC11Code": "49967-0768-04",
"ProductNDC": "49967-768",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Renergie Lift Multiaction Ultra Firming And Dark Spot Correcting Moisturizer Broad Spectrum Spf 30 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 50; 50; 70",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N"
},
{
"NDCCode": "63545-768-04",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (63545-768-04) ",
"NDC11Code": "63545-0768-04",
"ProductNDC": "63545-768",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Agaricus Muscarius",
"NonProprietaryName": "Agaricus Muscarius",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191227",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "AMANITA MUSCARIA FRUITING BODY",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191227",
"SamplePackage": "N"
},
{
"NDCCode": "71070-768-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (71070-768-04) / 113 g in 1 BOTTLE",
"NDC11Code": "71070-0768-04",
"ProductNDC": "71070-768",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jacket Spf 50",
"NonProprietaryName": "Zinc Oxide, Octinoxate, Octisalate, Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Balshi MD Dermaceuticals",
"SubstanceName": "ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "75; 75; 50; 50",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161118",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn: 1 If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "63304-768-01",
"PackageDescription": "75 mL in 1 BOTTLE (63304-768-01)",
"NDC11Code": "63304-0768-01",
"ProductNDC": "63304-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065207",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-768-02",
"PackageDescription": "200 mL in 1 BOTTLE (63304-768-02)",
"NDC11Code": "63304-0768-02",
"ProductNDC": "63304-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065207",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-768-03",
"PackageDescription": "50 mL in 1 BOTTLE (63304-768-03)",
"NDC11Code": "63304-0768-03",
"ProductNDC": "63304-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065207",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-768-07",
"PackageDescription": "125 mL in 1 BOTTLE (63304-768-07)",
"NDC11Code": "63304-0768-07",
"ProductNDC": "63304-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065207",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-768-50",
"PackageDescription": "150 mL in 1 BOTTLE (63304-768-50)",
"NDC11Code": "63304-0768-50",
"ProductNDC": "63304-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065207",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-132-04",
"PackageDescription": "250 TABLET, FILM COATED in 1 BOTTLE (63304-132-04) ",
"NDC11Code": "63304-0132-04",
"ProductNDC": "63304-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065356",
"LabelerName": "Sun Pharmaceutical Industries Inc.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2018-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180806",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline tablets are indicated for the treatment of the following infections. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline tablets are also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline tablets are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline tablets are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline tablets are an alternative drug in the treatment of the following infections:. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline tablets may be a useful adjunct to amebicides. In severe acne, doxycycline tablets may be useful adjunctive therapy.",
"Description": "Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg, 75 mg, and 50 mg tablets contain doxycycline monohydrate, USP equivalent to 150 mg, 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium starch glycolate, and titanium dioxide. In addition, doxycycline 50 mg tablets contain: FD&C Blue #1 Aluminum lake and polyethylene glycol, 75 mg tablets contain: D&C Yellow #10 Aluminum lake, FD&C Blue #1 Aluminum lake, FD&C Yellow #6 Aluminum lake and triacetin, 100 mg tablets contain: polyethylene glycol and FD&C Blue #1 Aluminum lake and 150 mg tablets contain: polyethylene glycol. Its molecular weight is 462.46. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8H2O. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form."
},
{
"NDCCode": "63304-821-04",
"PackageDescription": "100 mL in 1 BOTTLE (63304-821-04)",
"NDC11Code": "63304-0821-04",
"ProductNDC": "63304-821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "GRANULE, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20071003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065382",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clarithromycin tablets, USP and clarithromycin for oral suspension, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below. Adults (clarithromycin immediate-release tablets and clarithromycin for oral suspension). Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present). Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Community-Acquired Pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae (TWAR). Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage). Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare. Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules or TRITEC (ranitidine bismuth citrate) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. However, regimens which contain clarithromycin as the single antimicrobial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (For information on development of resistance see Microbiology section.) The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence. Children (clarithromycin immediate-release tablets and clarithromycin for oral suspension). Pharyngitis/Tonsillitis due to Streptococcus pyogenes. Community-Acquired Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae (TWAR). Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: For information on otitis media, see CLINICAL STUDIES - Otitis Media. Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.). Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare. Prophylaxis. Clarithromycin immediate-release tablets and clarithromycin for oral suspension are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin is available as immediate-release tablets, USP and granules for oral suspension, USP. Each light yellow capsule-shaped film-coated immediate-release clarithromycin tablet contains 250 mg or 500 mg of clarithromycin, USP and the following inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 lake, iron-oxide black, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, shellac glaze, stearic acid, talc, and titanium dioxide. After constitution, each 5 mL of clarithromycin for oral suspension contains 125 mg or 250 mg of clarithromycin, USP. Each bottle of clarithromycin for oral suspension, contains 1250 mg (50 mL size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of clarithromycin and the following inactive ingredients: alginic acid, aspartame*, castor oil, citric acid anhydrous, colloidal silicon dioxide, croscarmellose sodium, tutti fruitti flavor, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, maltodextrin, povidone, peppermint flavor, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose, titanium dioxide, xanthan gum. *See PRECAUTIONS – Information for Patient/ Phenylketonurics."
},
{
"NDCCode": "63304-822-04",
"PackageDescription": "100 mL in 1 BOTTLE (63304-822-04)",
"NDC11Code": "63304-0822-04",
"ProductNDC": "63304-822",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "GRANULE, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20071003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065382",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clarithromycin tablets, USP and clarithromycin for oral suspension, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below. Adults (clarithromycin immediate-release tablets and clarithromycin for oral suspension). Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present). Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Community-Acquired Pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae (TWAR). Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage). Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare. Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules or TRITEC (ranitidine bismuth citrate) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. However, regimens which contain clarithromycin as the single antimicrobial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (For information on development of resistance see Microbiology section.) The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence. Children (clarithromycin immediate-release tablets and clarithromycin for oral suspension). Pharyngitis/Tonsillitis due to Streptococcus pyogenes. Community-Acquired Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae (TWAR). Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: For information on otitis media, see CLINICAL STUDIES - Otitis Media. Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.). Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare. Prophylaxis. Clarithromycin immediate-release tablets and clarithromycin for oral suspension are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin is available as immediate-release tablets, USP and granules for oral suspension, USP. Each light yellow capsule-shaped film-coated immediate-release clarithromycin tablet contains 250 mg or 500 mg of clarithromycin, USP and the following inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 lake, iron-oxide black, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, shellac glaze, stearic acid, talc, and titanium dioxide. After constitution, each 5 mL of clarithromycin for oral suspension contains 125 mg or 250 mg of clarithromycin, USP. Each bottle of clarithromycin for oral suspension, contains 1250 mg (50 mL size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of clarithromycin and the following inactive ingredients: alginic acid, aspartame*, castor oil, citric acid anhydrous, colloidal silicon dioxide, croscarmellose sodium, tutti fruitti flavor, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, maltodextrin, povidone, peppermint flavor, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose, titanium dioxide, xanthan gum. *See PRECAUTIONS – Information for Patient/ Phenylketonurics."
},
{
"NDCCode": "63304-963-04",
"PackageDescription": "100 mL in 1 BOTTLE (63304-963-04)",
"NDC11Code": "63304-0963-04",
"ProductNDC": "63304-963",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil For Oral Suspension",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20080208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065323",
"LabelerName": "Ranbaxy Pharmaceuticals Inc",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-964-04",
"PackageDescription": "100 mL in 1 BOTTLE (63304-964-04)",
"NDC11Code": "63304-0964-04",
"ProductNDC": "63304-964",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil For Oral Suspension",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20080208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065323",
"LabelerName": "Ranbaxy Pharmaceuticals Inc",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-972-04",
"PackageDescription": "100 mL in 1 BOTTLE (63304-972-04)",
"NDC11Code": "63304-0972-04",
"ProductNDC": "63304-972",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefadroxil",
"NonProprietaryName": "Cefadroxil Monohydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20050830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065115",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "CEFADROXIL",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-973-04",
"PackageDescription": "100 mL in 1 BOTTLE (63304-973-04)",
"NDC11Code": "63304-0973-04",
"ProductNDC": "63304-973",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefadroxil",
"NonProprietaryName": "Cefadroxil Monohydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20050830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065115",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "CEFADROXIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63304-974-04",
"PackageDescription": "100 mL in 1 BOTTLE (63304-974-04)",
"NDC11Code": "63304-0974-04",
"ProductNDC": "63304-974",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefadroxil",
"NonProprietaryName": "Cefadroxil Monohydrate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20050830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065115",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "CEFADROXIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "31722-768-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (31722-768-01) ",
"NDC11Code": "31722-0768-01",
"ProductNDC": "31722-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204316",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240423",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "31722-768-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (31722-768-05) ",
"NDC11Code": "31722-0768-05",
"ProductNDC": "31722-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204316",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "31722-768-32",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (31722-768-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-768-31) ",
"NDC11Code": "31722-0768-32",
"ProductNDC": "31722-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204316",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "31722-768-34",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (31722-768-34) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-768-33) ",
"NDC11Code": "31722-0768-34",
"ProductNDC": "31722-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204316",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "31722-768-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (31722-768-60) ",
"NDC11Code": "31722-0768-60",
"ProductNDC": "31722-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204316",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "37000-768-06",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (37000-768-06) ",
"NDC11Code": "37000-0768-06",
"ProductNDC": "37000-768",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks",
"ProprietaryNameSuffix": "Cough And Cold Severe",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190423",
"EndMarketingDate": "20230203",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M012",
"LabelerName": "Procter & Gamble Manufacturing Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190423",
"EndMarketingDatePackage": "20230203",
"SamplePackage": "N"
},
{
"NDCCode": "46122-768-36",
"PackageDescription": "1 TUBE in 1 CARTON (46122-768-36) / 15 g in 1 TUBE",
"NDC11Code": "46122-0768-36",
"ProductNDC": "46122-768",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215940",
"LabelerName": "AMERISOURCE BERGEN",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240226",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
},
{
"NDCCode": "46708-768-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-768-30) ",
"NDC11Code": "46708-0768-30",
"ProductNDC": "46708-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217280",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine extended-release tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Paroxetine extended-release tablets USP, contains paroxetine hydrochloride, USP an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4’-fluorophenyl)-3S-[(3’,4’ methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride, USP is. Paroxetine hydrochloride, USP is white or almost white crystalline powder, having a melting point range of 120oC to 138oC and soluble in methanol and in alcohol, slightly soluble in water. Paroxetine extended-release tablets, USP are intended for oral administration. Each extended-release tablet contains 12.5 mg, 25 mg or 37.5 mg paroxetine equivalent to 14.22 mg, 28.51 mg or 42.76 mg of paroxetine hydrochloride USP, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of colloidal silicon dioxide, glyceryl dibehenate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, povidone K-30, talc and triethyl citrate. The film-coating material contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000 and titanium dioxide. Additionally, 12.5 mg tablets contain D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Aluminium Lake and polysorbate 80, 25 mg tablets contain D&C Red No. 30 Lake and polysorbate 80 and 37.5 mg tablets contain FD&C Blue No. 2 Aluminium Lake and talc. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "46708-768-91",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-768-91) ",
"NDC11Code": "46708-0768-91",
"ProductNDC": "46708-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217280",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine extended-release tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Paroxetine extended-release tablets USP, contains paroxetine hydrochloride, USP an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4’-fluorophenyl)-3S-[(3’,4’ methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride, USP is. Paroxetine hydrochloride, USP is white or almost white crystalline powder, having a melting point range of 120oC to 138oC and soluble in methanol and in alcohol, slightly soluble in water. Paroxetine extended-release tablets, USP are intended for oral administration. Each extended-release tablet contains 12.5 mg, 25 mg or 37.5 mg paroxetine equivalent to 14.22 mg, 28.51 mg or 42.76 mg of paroxetine hydrochloride USP, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of colloidal silicon dioxide, glyceryl dibehenate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, povidone K-30, talc and triethyl citrate. The film-coating material contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000 and titanium dioxide. Additionally, 12.5 mg tablets contain D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Aluminium Lake and polysorbate 80, 25 mg tablets contain D&C Red No. 30 Lake and polysorbate 80 and 37.5 mg tablets contain FD&C Blue No. 2 Aluminium Lake and talc. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "50419-344-05",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50419-344-05) / 50 mL in 1 VIAL, GLASS",
"NDC11Code": "50419-0344-05",
"ProductNDC": "50419-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravist",
"NonProprietaryName": "Iopromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
"StartMarketingDate": "20091230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020220",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "IOPROMIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091230",
"SamplePackage": "N",
"IndicationAndUsage": "ULTRAVIST® Injection is an iodinated contrast agent indicated for.",
"Description": "ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water)."
},
{
"NDCCode": "50419-344-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50419-344-10) / 100 mL in 1 VIAL, GLASS",
"NDC11Code": "50419-0344-10",
"ProductNDC": "50419-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravist",
"NonProprietaryName": "Iopromide",
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"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020220",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "IOPROMIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091230",
"SamplePackage": "N",
"IndicationAndUsage": "ULTRAVIST® Injection is an iodinated contrast agent indicated for.",
"Description": "ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water)."
},
{
"NDCCode": "50419-344-12",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50419-344-12) / 125 mL in 1 VIAL, GLASS",
"NDC11Code": "50419-0344-12",
"ProductNDC": "50419-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravist",
"NonProprietaryName": "Iopromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
"StartMarketingDate": "20091230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020220",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "IOPROMIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091230",
"SamplePackage": "N",
"IndicationAndUsage": "ULTRAVIST® Injection is an iodinated contrast agent indicated for.",
"Description": "ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water)."
},
{
"NDCCode": "50419-344-15",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (50419-344-15) / 150 mL in 1 VIAL, GLASS",
"NDC11Code": "50419-0344-15",
"ProductNDC": "50419-344",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultravist",
"NonProprietaryName": "Iopromide",
"DosageFormName": "INJECTION",
"RouteName": "INTRA-ARTERIAL; INTRAVENOUS",
"StartMarketingDate": "20091230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020220",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "IOPROMIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091230",
"SamplePackage": "N",
"IndicationAndUsage": "ULTRAVIST® Injection is an iodinated contrast agent indicated for.",
"Description": "ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water)."
}
]
}
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<ProductNDC>49967-768</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Renergie Lift Multiaction Ultra Firming And Dark Spot Correcting Moisturizer Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate And Octocrylene</NonProprietaryName>
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<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (63545-768-04) </PackageDescription>
<NDC11Code>63545-0768-04</NDC11Code>
<ProductNDC>63545-768</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Agaricus Muscarius</ProprietaryName>
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<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>71070-768-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (71070-768-04) / 113 g in 1 BOTTLE</PackageDescription>
<NDC11Code>71070-0768-04</NDC11Code>
<ProductNDC>71070-768</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jacket Spf 50</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Octinoxate, Octisalate, Octisalate</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Balshi MD Dermaceuticals</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 75; 50; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn: 1 If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
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<NDC>
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<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<ProductNDC>63304-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
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<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63304-768-07</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
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<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63304-768-50</NDCCode>
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<ProductNDC>63304-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
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<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63304-132-04</NDCCode>
<PackageDescription>250 TABLET, FILM COATED in 1 BOTTLE (63304-132-04) </PackageDescription>
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<ProductNDC>63304-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065356</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline tablets are indicated for the treatment of the following infections. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline tablets are also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline tablets are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline tablets are indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline tablets are an alternative drug in the treatment of the following infections:. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline tablets may be a useful adjunct to amebicides. In severe acne, doxycycline tablets may be useful adjunctive therapy.</IndicationAndUsage>
<Description>Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg, 75 mg, and 50 mg tablets contain doxycycline monohydrate, USP equivalent to 150 mg, 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium starch glycolate, and titanium dioxide. In addition, doxycycline 50 mg tablets contain: FD&C Blue #1 Aluminum lake and polyethylene glycol, 75 mg tablets contain: D&C Yellow #10 Aluminum lake, FD&C Blue #1 Aluminum lake, FD&C Yellow #6 Aluminum lake and triacetin, 100 mg tablets contain: polyethylene glycol and FD&C Blue #1 Aluminum lake and 150 mg tablets contain: polyethylene glycol. Its molecular weight is 462.46. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8H2O. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.</Description>
</NDC>
<NDC>
<NDCCode>63304-821-04</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63304-821-04)</PackageDescription>
<NDC11Code>63304-0821-04</NDC11Code>
<ProductNDC>63304-821</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>GRANULE, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065382</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clarithromycin tablets, USP and clarithromycin for oral suspension, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below. Adults (clarithromycin immediate-release tablets and clarithromycin for oral suspension). Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present). Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Community-Acquired Pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae (TWAR). Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage). Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare. Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules or TRITEC (ranitidine bismuth citrate) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. However, regimens which contain clarithromycin as the single antimicrobial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (For information on development of resistance see Microbiology section.) The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence. Children (clarithromycin immediate-release tablets and clarithromycin for oral suspension). Pharyngitis/Tonsillitis due to Streptococcus pyogenes. Community-Acquired Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae (TWAR). Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: For information on otitis media, see CLINICAL STUDIES - Otitis Media. Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.). Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare. Prophylaxis. Clarithromycin immediate-release tablets and clarithromycin for oral suspension are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin is available as immediate-release tablets, USP and granules for oral suspension, USP. Each light yellow capsule-shaped film-coated immediate-release clarithromycin tablet contains 250 mg or 500 mg of clarithromycin, USP and the following inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 lake, iron-oxide black, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, shellac glaze, stearic acid, talc, and titanium dioxide. After constitution, each 5 mL of clarithromycin for oral suspension contains 125 mg or 250 mg of clarithromycin, USP. Each bottle of clarithromycin for oral suspension, contains 1250 mg (50 mL size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of clarithromycin and the following inactive ingredients: alginic acid, aspartame*, castor oil, citric acid anhydrous, colloidal silicon dioxide, croscarmellose sodium, tutti fruitti flavor, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, maltodextrin, povidone, peppermint flavor, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose, titanium dioxide, xanthan gum. *See PRECAUTIONS – Information for Patient/ Phenylketonurics.</Description>
</NDC>
<NDC>
<NDCCode>63304-822-04</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63304-822-04)</PackageDescription>
<NDC11Code>63304-0822-04</NDC11Code>
<ProductNDC>63304-822</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>GRANULE, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065382</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clarithromycin tablets, USP and clarithromycin for oral suspension, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below. Adults (clarithromycin immediate-release tablets and clarithromycin for oral suspension). Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present). Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Community-Acquired Pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae (TWAR). Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage). Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare. Clarithromycin tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori. Clarithromycin tablets in combination with PRILOSEC (omeprazole) capsules or TRITEC (ranitidine bismuth citrate) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. However, regimens which contain clarithromycin as the single antimicrobial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (For information on development of resistance see Microbiology section.) The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence. Children (clarithromycin immediate-release tablets and clarithromycin for oral suspension). Pharyngitis/Tonsillitis due to Streptococcus pyogenes. Community-Acquired Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae (TWAR). Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. NOTE: For information on otitis media, see CLINICAL STUDIES - Otitis Media. Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.). Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare. Prophylaxis. Clarithromycin immediate-release tablets and clarithromycin for oral suspension are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.95. The structural formula is. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin is available as immediate-release tablets, USP and granules for oral suspension, USP. Each light yellow capsule-shaped film-coated immediate-release clarithromycin tablet contains 250 mg or 500 mg of clarithromycin, USP and the following inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 lake, iron-oxide black, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, shellac glaze, stearic acid, talc, and titanium dioxide. After constitution, each 5 mL of clarithromycin for oral suspension contains 125 mg or 250 mg of clarithromycin, USP. Each bottle of clarithromycin for oral suspension, contains 1250 mg (50 mL size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of clarithromycin and the following inactive ingredients: alginic acid, aspartame*, castor oil, citric acid anhydrous, colloidal silicon dioxide, croscarmellose sodium, tutti fruitti flavor, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, maltodextrin, povidone, peppermint flavor, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose, titanium dioxide, xanthan gum. *See PRECAUTIONS – Information for Patient/ Phenylketonurics.</Description>
</NDC>
<NDC>
<NDCCode>63304-963-04</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63304-963-04)</PackageDescription>
<NDC11Code>63304-0963-04</NDC11Code>
<ProductNDC>63304-963</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Axetil For Oral Suspension</ProprietaryName>
<NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065323</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc</LabelerName>
<SubstanceName>CEFUROXIME AXETIL</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63304-964-04</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63304-964-04)</PackageDescription>
<NDC11Code>63304-0964-04</NDC11Code>
<ProductNDC>63304-964</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Axetil For Oral Suspension</ProprietaryName>
<NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065323</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc</LabelerName>
<SubstanceName>CEFUROXIME AXETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63304-972-04</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63304-972-04)</PackageDescription>
<NDC11Code>63304-0972-04</NDC11Code>
<ProductNDC>63304-972</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefadroxil</ProprietaryName>
<NonProprietaryName>Cefadroxil Monohydrate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065115</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CEFADROXIL</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63304-973-04</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63304-973-04)</PackageDescription>
<NDC11Code>63304-0973-04</NDC11Code>
<ProductNDC>63304-973</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefadroxil</ProprietaryName>
<NonProprietaryName>Cefadroxil Monohydrate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065115</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CEFADROXIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63304-974-04</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63304-974-04)</PackageDescription>
<NDC11Code>63304-0974-04</NDC11Code>
<ProductNDC>63304-974</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefadroxil</ProprietaryName>
<NonProprietaryName>Cefadroxil Monohydrate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065115</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CEFADROXIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>31722-768-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (31722-768-01) </PackageDescription>
<NDC11Code>31722-0768-01</NDC11Code>
<ProductNDC>31722-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204316</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>31722-768-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (31722-768-05) </PackageDescription>
<NDC11Code>31722-0768-05</NDC11Code>
<ProductNDC>31722-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204316</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
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<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
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<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)-ethoxy] ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2. C4H4O4 and it has a molecular weight of 883.1 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is sparingly soluble in 0.1N hydrochloric acid, slightly soluble in water, in anhydrous ethanol and in methanol. Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
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<NDC11Code>37000-0768-06</NDC11Code>
<ProductNDC>37000-768</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks</ProprietaryName>
<ProprietaryNameSuffix>Cough And Cold Severe</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190423</StartMarketingDate>
<EndMarketingDate>20230203</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190423</StartMarketingDatePackage>
<EndMarketingDatePackage>20230203</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46122-768-36</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (46122-768-36) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>46122-0768-36</NDC11Code>
<ProductNDC>46122-768</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Adapalene</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215940</ApplicationNumber>
<LabelerName>AMERISOURCE BERGEN</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
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<NDC>
<NDCCode>46708-768-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-768-30) </PackageDescription>
<NDC11Code>46708-0768-30</NDC11Code>
<ProductNDC>46708-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217280</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine extended-release tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Paroxetine extended-release tablets USP, contains paroxetine hydrochloride, USP an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4’-fluorophenyl)-3S-[(3’,4’ methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride, USP is. Paroxetine hydrochloride, USP is white or almost white crystalline powder, having a melting point range of 120oC to 138oC and soluble in methanol and in alcohol, slightly soluble in water. Paroxetine extended-release tablets, USP are intended for oral administration. Each extended-release tablet contains 12.5 mg, 25 mg or 37.5 mg paroxetine equivalent to 14.22 mg, 28.51 mg or 42.76 mg of paroxetine hydrochloride USP, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of colloidal silicon dioxide, glyceryl dibehenate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, povidone K-30, talc and triethyl citrate. The film-coating material contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000 and titanium dioxide. Additionally, 12.5 mg tablets contain D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Aluminium Lake and polysorbate 80, 25 mg tablets contain D&C Red No. 30 Lake and polysorbate 80 and 37.5 mg tablets contain FD&C Blue No. 2 Aluminium Lake and talc. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>46708-768-91</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-768-91) </PackageDescription>
<NDC11Code>46708-0768-91</NDC11Code>
<ProductNDC>46708-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217280</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine extended-release tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Paroxetine extended-release tablets USP, contains paroxetine hydrochloride, USP an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4’-fluorophenyl)-3S-[(3’,4’ methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride, USP is. Paroxetine hydrochloride, USP is white or almost white crystalline powder, having a melting point range of 120oC to 138oC and soluble in methanol and in alcohol, slightly soluble in water. Paroxetine extended-release tablets, USP are intended for oral administration. Each extended-release tablet contains 12.5 mg, 25 mg or 37.5 mg paroxetine equivalent to 14.22 mg, 28.51 mg or 42.76 mg of paroxetine hydrochloride USP, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of colloidal silicon dioxide, glyceryl dibehenate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, povidone K-30, talc and triethyl citrate. The film-coating material contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000 and titanium dioxide. Additionally, 12.5 mg tablets contain D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Aluminium Lake and polysorbate 80, 25 mg tablets contain D&C Red No. 30 Lake and polysorbate 80 and 37.5 mg tablets contain FD&C Blue No. 2 Aluminium Lake and talc. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>50419-344-05</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (50419-344-05) / 50 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50419-0344-05</NDC11Code>
<ProductNDC>50419-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravist</ProprietaryName>
<NonProprietaryName>Iopromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20091230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020220</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IOPROMIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTRAVIST® Injection is an iodinated contrast agent indicated for.</IndicationAndUsage>
<Description>ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water).</Description>
</NDC>
<NDC>
<NDCCode>50419-344-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (50419-344-10) / 100 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50419-0344-10</NDC11Code>
<ProductNDC>50419-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravist</ProprietaryName>
<NonProprietaryName>Iopromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20091230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020220</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IOPROMIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTRAVIST® Injection is an iodinated contrast agent indicated for.</IndicationAndUsage>
<Description>ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water).</Description>
</NDC>
<NDC>
<NDCCode>50419-344-12</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (50419-344-12) / 125 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50419-0344-12</NDC11Code>
<ProductNDC>50419-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravist</ProprietaryName>
<NonProprietaryName>Iopromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20091230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020220</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IOPROMIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTRAVIST® Injection is an iodinated contrast agent indicated for.</IndicationAndUsage>
<Description>ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water).</Description>
</NDC>
<NDC>
<NDCCode>50419-344-15</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (50419-344-15) / 150 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50419-0344-15</NDC11Code>
<ProductNDC>50419-344</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultravist</ProprietaryName>
<NonProprietaryName>Iopromide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20091230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020220</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IOPROMIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTRAVIST® Injection is an iodinated contrast agent indicated for.</IndicationAndUsage>
<Description>ULTRAVIST(iopromide) injection is a nonionic radiographic contrast agent for intra-arterial or intravenous administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula. Each mL contains 623.4 mg or 768.86 mg iopromide (300 mg or 370 mg iodine, respectively) and the following inactive ingredients: 0.1 mg edetate calcium disodium as a stabilizer and 2.42 mg tromethamine as a buffer. It may also contain sodium hydroxide or hydrochloric acid to adjust pH to 7.4 (6.5–8) at 25± 2°C and contains no preservatives. ULTRAVIST is a sterile (sterilized by autoclaving), clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution and has the following physicochemical properties. ULTRAVIST 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water).</Description>
</NDC>
</NDCList>