{
"NDC": [
{
"NDCCode": "51552-0586-6",
"PackageDescription": "500 g in 1 CONTAINER (51552-0586-6)",
"NDC11Code": "51552-0586-06",
"ProductNDC": "51552-0586",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ferrous Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "FERROUS SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "15631-0586-6",
"PackageDescription": "1000 TABLET in 1 CONTAINER (15631-0586-6)",
"NDC11Code": "15631-0586-06",
"ProductNDC": "15631-0586",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fraxinus Americana",
"NonProprietaryName": "Fraxinus Americana",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "FRAXINUS AMERICANA BARK",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "54868-0586-6",
"PackageDescription": "100 TABLET in 1 BOTTLE (54868-0586-6)",
"NDC11Code": "54868-0586-06",
"ProductNDC": "54868-0586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085159",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate."
},
{
"NDCCode": "10135-586-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-586-01)",
"NDC11Code": "10135-0586-01",
"ProductNDC": "10135-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090695",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects. CONTRAINDICATIONS. Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.). Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25, or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue#1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone."
},
{
"NDCCode": "10135-586-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10135-586-10)",
"NDC11Code": "10135-0586-10",
"ProductNDC": "10135-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loxapine",
"NonProprietaryName": "Loxapine Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090695",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "LOXAPINE SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects. CONTRAINDICATIONS. Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.). Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.",
"Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25, or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue#1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone."
},
{
"NDCCode": "13668-586-01",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-01) ",
"NDC11Code": "13668-0586-01",
"ProductNDC": "13668-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211975",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210726",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin delayed-release tablets and other antibacterial drugs, erythromycin delayed-release 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. Erythromycin delayed-release tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: ErythrocinTM Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis. Prevention of Initial Attacks of Rheumatic Fever. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).1 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Prevention of Recurrent Attacks of Rheumatic Fever. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.",
"Description": "Erythromycin delayed-release tablets are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets for oral administration are available in three dosage strengths, each white to off white oval tablet containing 250 mg, 333 mg and 500 mg of erythromycin as the free base. Erythromycin delayed-release tablets comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, freely soluble in alcohol and soluble in methanol. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3- dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.93. The structural formula is."
},
{
"NDCCode": "13668-586-05",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-05) ",
"NDC11Code": "13668-0586-05",
"ProductNDC": "13668-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211975",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210726",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin delayed-release tablets and other antibacterial drugs, erythromycin delayed-release 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. Erythromycin delayed-release tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: ErythrocinTM Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis. Prevention of Initial Attacks of Rheumatic Fever. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).1 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Prevention of Recurrent Attacks of Rheumatic Fever. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.",
"Description": "Erythromycin delayed-release tablets are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets for oral administration are available in three dosage strengths, each white to off white oval tablet containing 250 mg, 333 mg and 500 mg of erythromycin as the free base. Erythromycin delayed-release tablets comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, freely soluble in alcohol and soluble in methanol. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3- dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.93. The structural formula is."
},
{
"NDCCode": "13668-586-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-30) ",
"NDC11Code": "13668-0586-30",
"ProductNDC": "13668-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211975",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210921",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin delayed-release tablets and other antibacterial drugs, erythromycin delayed-release 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. Erythromycin delayed-release tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: ErythrocinTM Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis. Prevention of Initial Attacks of Rheumatic Fever. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).1 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Prevention of Recurrent Attacks of Rheumatic Fever. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.",
"Description": "Erythromycin delayed-release tablets are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets for oral administration are available in three dosage strengths, each white to off white oval tablet containing 250 mg, 333 mg and 500 mg of erythromycin as the free base. Erythromycin delayed-release tablets comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, freely soluble in alcohol and soluble in methanol. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3- dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.93. The structural formula is."
},
{
"NDCCode": "31722-586-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-586-01) ",
"NDC11Code": "31722-0586-01",
"ProductNDC": "31722-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203825",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210917",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "31722-586-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (31722-586-30) ",
"NDC11Code": "31722-0586-30",
"ProductNDC": "31722-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203825",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210917",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "31722-586-32",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-586-32) / 10 TABLET in 1 BLISTER PACK (31722-586-31) ",
"NDC11Code": "31722-0586-32",
"ProductNDC": "31722-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203825",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210917",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "31722-586-34",
"PackageDescription": "18 BLISTER PACK in 1 CARTON (31722-586-34) / 7 TABLET in 1 BLISTER PACK (31722-586-33) ",
"NDC11Code": "31722-0586-34",
"ProductNDC": "31722-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203825",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210917",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "31722-586-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (31722-586-90) ",
"NDC11Code": "31722-0586-90",
"ProductNDC": "31722-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203825",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210917",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "33342-586-07",
"PackageDescription": "30 TABLET in 1 BOTTLE (33342-586-07) ",
"NDC11Code": "33342-0586-07",
"ProductNDC": "33342-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211506",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "33342-586-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-586-10) ",
"NDC11Code": "33342-0586-10",
"ProductNDC": "33342-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211506",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "33342-586-56",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-586-56) / 14 TABLET in 1 BLISTER PACK (33342-586-66) ",
"NDC11Code": "33342-0586-56",
"ProductNDC": "33342-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211506",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "35000-586-02",
"PackageDescription": "56.6 g in 1 CONTAINER (35000-586-02) ",
"NDC11Code": "35000-0586-02",
"ProductNDC": "35000-586",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Speed Stick",
"ProprietaryNameSuffix": "Power Invigorate Antiperspirant Deodorant",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130118",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Colgate-Palmolive",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "160",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2021-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130122",
"SamplePackage": "N"
},
{
"NDCCode": "37662-0586-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-0586-1) ",
"NDC11Code": "37662-0586-01",
"ProductNDC": "37662-0586",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cuprum Aceticum",
"NonProprietaryName": "Cuprum Aceticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CUPRIC ACETATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N"
},
{
"NDCCode": "37662-0586-2",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-0586-2) ",
"NDC11Code": "37662-0586-02",
"ProductNDC": "37662-0586",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cuprum Aceticum",
"NonProprietaryName": "Cuprum Aceticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CUPRIC ACETATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N"
},
{
"NDCCode": "37662-0586-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-0586-3) ",
"NDC11Code": "37662-0586-03",
"ProductNDC": "37662-0586",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cuprum Aceticum",
"NonProprietaryName": "Cuprum Aceticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220615",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "CUPRIC ACETATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220615",
"SamplePackage": "N"
},
{
"NDCCode": "41250-586-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (41250-586-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "41250-0586-24",
"ProductNDC": "41250-586",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20200916",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "MEIJER DISTRIBUTION, INC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200916",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches/pains, 5 fever, 6 runny nose and sneezing."
},
{
"NDCCode": "42549-586-42",
"PackageDescription": "42 TABLET in 1 BOTTLE (42549-586-42)",
"NDC11Code": "42549-0586-42",
"ProductNDC": "42549-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040769",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 750",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O62½H2O M.W. 494.50. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. 151.16. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains. Hydrocodone Bitartrate, USP ........................ 7.5 mg. Acetaminophen, USP .................................... 750 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 1."
},
{
"NDCCode": "42549-586-84",
"PackageDescription": "84 TABLET in 1 BOTTLE (42549-586-84)",
"NDC11Code": "42549-0586-84",
"ProductNDC": "42549-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040769",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 750",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O62½H2O M.W. 494.50. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. 151.16. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains. Hydrocodone Bitartrate, USP ........................ 7.5 mg. Acetaminophen, USP .................................... 750 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 1."
},
{
"NDCCode": "42858-586-40",
"PackageDescription": "4 POUCH in 1 CARTON (42858-586-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "42858-0586-40",
"ProductNDC": "42858-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20170703",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021306",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "15",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170705",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Buprenorphine Transdermal System is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine- containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum."
},
{
"NDCCode": "43742-0586-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0586-1)",
"NDC11Code": "43742-0586-01",
"ProductNDC": "43742-0586",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Energy Catalyst",
"NonProprietaryName": "Viscum Album, Cobalt Gluconate, Cuprum Sulphuricum, Ferrous Fumarate, Magnesium Aspartate, Manganese Gluconate, Phosphorus, Potassium Aspartate, Sodium Molybdate, Adenosinum Cyclophosphoricum, Cerium Oxalicum, Nickel Acetate, Vitamin D3, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150721",
"EndMarketingDate": "20201109",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "DESERET BIOLOGICALS, INC.",
"SubstanceName": "VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; MAGNESIUM ASPARTATE; MANGANESE GLUCONATE; PHOSPHORUS; POTASSIUM ASPARTATE; SODIUM MOLYBDATE; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANIUM; VANADIUM; YTTERBIUM OXIDE; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; LANTHANUM; NIOBIUM; TANTALUM; PROTEUS MORGANII",
"StrengthNumber": "3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 14; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-11",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "46708-586-31",
"PackageDescription": "100 TABLET in 1 BOTTLE (46708-586-31) ",
"NDC11Code": "46708-0586-31",
"ProductNDC": "46708-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine",
"NonProprietaryName": "Amantadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214284",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "Amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride tablets do not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine hydrochloride tablets prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride tablets are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride tablets will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride tablets are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride tablets: 1 Amantadine hydrochloride tablets are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. , 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride tablets. .",
"Description": "Amantadine hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride. Amantadine hydrochloride, USP is a stable white or practically white crystalline powder, freely soluble in water, soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each tablet intended for oral administration contains 100 mg amantadine hydrochloride, USP and has the following inactive ingredients: microcrystalline cellulose, povidone K-30, povidone K-90, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and FD&C Yellow No. 6 Aluminium Lake."
},
{
"NDCCode": "46708-586-71",
"PackageDescription": "500 TABLET in 1 BOTTLE (46708-586-71) ",
"NDC11Code": "46708-0586-71",
"ProductNDC": "46708-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine",
"NonProprietaryName": "Amantadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214284",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201020",
"SamplePackage": "N",
"IndicationAndUsage": "Amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride tablets do not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine hydrochloride tablets prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride tablets are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride tablets will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride tablets are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride tablets: 1 Amantadine hydrochloride tablets are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. , 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride tablets. .",
"Description": "Amantadine hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride. Amantadine hydrochloride, USP is a stable white or practically white crystalline powder, freely soluble in water, soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each tablet intended for oral administration contains 100 mg amantadine hydrochloride, USP and has the following inactive ingredients: microcrystalline cellulose, povidone K-30, povidone K-90, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and FD&C Yellow No. 6 Aluminium Lake."
},
{
"NDCCode": "47335-586-08",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (47335-586-08) ",
"NDC11Code": "47335-0586-08",
"ProductNDC": "47335-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091103",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2018-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140415",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg)."
},
{
"NDCCode": "47335-586-18",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-586-18) ",
"NDC11Code": "47335-0586-18",
"ProductNDC": "47335-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091103",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2018-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140415",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg)."
},
{
"NDCCode": "47335-586-83",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (47335-586-83) ",
"NDC11Code": "47335-0586-83",
"ProductNDC": "47335-586",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091103",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2018-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140415",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg)."
}
]
}
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<NDCCode>51552-0586-6</NDCCode>
<PackageDescription>500 g in 1 CONTAINER (51552-0586-6)</PackageDescription>
<NDC11Code>51552-0586-06</NDC11Code>
<ProductNDC>51552-0586</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
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<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15631-0586-6</NDCCode>
<PackageDescription>1000 TABLET in 1 CONTAINER (15631-0586-6)</PackageDescription>
<NDC11Code>15631-0586-06</NDC11Code>
<ProductNDC>15631-0586</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fraxinus Americana</ProprietaryName>
<NonProprietaryName>Fraxinus Americana</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>FRAXINUS AMERICANA BARK</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-0586-6</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (54868-0586-6)</PackageDescription>
<NDC11Code>54868-0586-06</NDC11Code>
<ProductNDC>54868-0586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085159</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10135-586-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-586-01)</PackageDescription>
<NDC11Code>10135-0586-01</NDC11Code>
<ProductNDC>10135-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090695</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects. CONTRAINDICATIONS. Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.). Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25, or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue#1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>10135-586-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10135-586-10)</PackageDescription>
<NDC11Code>10135-0586-10</NDC11Code>
<ProductNDC>10135-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loxapine</ProprietaryName>
<NonProprietaryName>Loxapine Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090695</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>LOXAPINE SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects. CONTRAINDICATIONS. Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.). Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.</IndicationAndUsage>
<Description>Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25, or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue#1. Additionally, the 5 mg capsule contains D&C Red #33, the 10 mg capsule contains D&C Red #33 and D&C Red #28, and the 25 mg capsule contains FD&C Yellow #6. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>13668-586-01</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-01) </PackageDescription>
<NDC11Code>13668-0586-01</NDC11Code>
<ProductNDC>13668-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211975</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin delayed-release tablets and other antibacterial drugs, erythromycin delayed-release 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. Erythromycin delayed-release tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: ErythrocinTM Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis. Prevention of Initial Attacks of Rheumatic Fever. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).1 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Prevention of Recurrent Attacks of Rheumatic Fever. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.</IndicationAndUsage>
<Description>Erythromycin delayed-release tablets are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets for oral administration are available in three dosage strengths, each white to off white oval tablet containing 250 mg, 333 mg and 500 mg of erythromycin as the free base. Erythromycin delayed-release tablets comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, freely soluble in alcohol and soluble in methanol. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3- dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.93. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>13668-586-05</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-05) </PackageDescription>
<NDC11Code>13668-0586-05</NDC11Code>
<ProductNDC>13668-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211975</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin delayed-release tablets and other antibacterial drugs, erythromycin delayed-release 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. Erythromycin delayed-release tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: ErythrocinTM Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis. Prevention of Initial Attacks of Rheumatic Fever. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).1 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Prevention of Recurrent Attacks of Rheumatic Fever. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.</IndicationAndUsage>
<Description>Erythromycin delayed-release tablets are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets for oral administration are available in three dosage strengths, each white to off white oval tablet containing 250 mg, 333 mg and 500 mg of erythromycin as the free base. Erythromycin delayed-release tablets comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, freely soluble in alcohol and soluble in methanol. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3- dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.93. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>13668-586-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-586-30) </PackageDescription>
<NDC11Code>13668-0586-30</NDC11Code>
<ProductNDC>13668-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211975</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin delayed-release tablets and other antibacterial drugs, erythromycin delayed-release 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. Erythromycin delayed-release tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: ErythrocinTM Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis. Prevention of Initial Attacks of Rheumatic Fever. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).1 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days. Prevention of Recurrent Attacks of Rheumatic Fever. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.</IndicationAndUsage>
<Description>Erythromycin delayed-release tablets are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets for oral administration are available in three dosage strengths, each white to off white oval tablet containing 250 mg, 333 mg and 500 mg of erythromycin as the free base. Erythromycin delayed-release tablets comply with USP Dissolution Test 1. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, freely soluble in alcohol and soluble in methanol. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3- dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.93. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>31722-586-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-586-01) </PackageDescription>
<NDC11Code>31722-0586-01</NDC11Code>
<ProductNDC>31722-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203825</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>31722-586-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (31722-586-30) </PackageDescription>
<NDC11Code>31722-0586-30</NDC11Code>
<ProductNDC>31722-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203825</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>31722-586-32</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-586-32) / 10 TABLET in 1 BLISTER PACK (31722-586-31) </PackageDescription>
<NDC11Code>31722-0586-32</NDC11Code>
<ProductNDC>31722-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203825</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>31722-586-34</NDCCode>
<PackageDescription>18 BLISTER PACK in 1 CARTON (31722-586-34) / 7 TABLET in 1 BLISTER PACK (31722-586-33) </PackageDescription>
<NDC11Code>31722-0586-34</NDC11Code>
<ProductNDC>31722-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203825</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>31722-586-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (31722-586-90) </PackageDescription>
<NDC11Code>31722-0586-90</NDC11Code>
<ProductNDC>31722-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203825</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol tablet is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets is (αR,α’R,2R,2’S)-rel-α,α’-[Iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Molecular Weight: 441.9 g/mol Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red No.27 AL Lake, FD & C Yellow No.6 AL, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>33342-586-07</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33342-586-07) </PackageDescription>
<NDC11Code>33342-0586-07</NDC11Code>
<ProductNDC>33342-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211506</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>33342-586-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-586-10) </PackageDescription>
<NDC11Code>33342-0586-10</NDC11Code>
<ProductNDC>33342-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211506</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>33342-586-56</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-586-56) / 14 TABLET in 1 BLISTER PACK (33342-586-66) </PackageDescription>
<NDC11Code>33342-0586-56</NDC11Code>
<ProductNDC>33342-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211506</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>35000-586-02</NDCCode>
<PackageDescription>56.6 g in 1 CONTAINER (35000-586-02) </PackageDescription>
<NDC11Code>35000-0586-02</NDC11Code>
<ProductNDC>35000-586</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Speed Stick</ProprietaryName>
<ProprietaryNameSuffix>Power Invigorate Antiperspirant Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Colgate-Palmolive</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-0586-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-0586-1) </PackageDescription>
<NDC11Code>37662-0586-01</NDC11Code>
<ProductNDC>37662-0586</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cuprum Aceticum</ProprietaryName>
<NonProprietaryName>Cuprum Aceticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CUPRIC ACETATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-0586-2</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-0586-2) </PackageDescription>
<NDC11Code>37662-0586-02</NDC11Code>
<ProductNDC>37662-0586</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cuprum Aceticum</ProprietaryName>
<NonProprietaryName>Cuprum Aceticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CUPRIC ACETATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-0586-3</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-0586-3) </PackageDescription>
<NDC11Code>37662-0586-03</NDC11Code>
<ProductNDC>37662-0586</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cuprum Aceticum</ProprietaryName>
<NonProprietaryName>Cuprum Aceticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220615</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>CUPRIC ACETATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41250-586-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (41250-586-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41250-0586-24</NDC11Code>
<ProductNDC>41250-586</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>MEIJER DISTRIBUTION, INC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches/pains, 5 fever, 6 runny nose and sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42549-586-42</NDCCode>
<PackageDescription>42 TABLET in 1 BOTTLE (42549-586-42)</PackageDescription>
<NDC11Code>42549-0586-42</NDC11Code>
<ProductNDC>42549-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040769</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 750</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O62½H2O M.W. 494.50. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. 151.16. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains. Hydrocodone Bitartrate, USP ........................ 7.5 mg. Acetaminophen, USP .................................... 750 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42549-586-84</NDCCode>
<PackageDescription>84 TABLET in 1 BOTTLE (42549-586-84)</PackageDescription>
<NDC11Code>42549-0586-84</NDC11Code>
<ProductNDC>42549-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040769</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 750</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O62½H2O M.W. 494.50. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W. 151.16. Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains. Hydrocodone Bitartrate, USP ........................ 7.5 mg. Acetaminophen, USP .................................... 750 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>42858-586-40</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (42858-586-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>42858-0586-40</NDC11Code>
<ProductNDC>42858-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20170703</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021306</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Buprenorphine Transdermal System is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of buprenorphine transdermal system are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. Buprenorphine transdermal system is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine- containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of Buprenorphine Transdermal System (not to scale). The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.</Description>
</NDC>
<NDC>
<NDCCode>43742-0586-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-0586-1)</PackageDescription>
<NDC11Code>43742-0586-01</NDC11Code>
<ProductNDC>43742-0586</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Energy Catalyst</ProprietaryName>
<NonProprietaryName>Viscum Album, Cobalt Gluconate, Cuprum Sulphuricum, Ferrous Fumarate, Magnesium Aspartate, Manganese Gluconate, Phosphorus, Potassium Aspartate, Sodium Molybdate, Adenosinum Cyclophosphoricum, Cerium Oxalicum, Nickel Acetate, Vitamin D3, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150721</StartMarketingDate>
<EndMarketingDate>20201109</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>DESERET BIOLOGICALS, INC.</LabelerName>
<SubstanceName>VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; MAGNESIUM ASPARTATE; MANGANESE GLUCONATE; PHOSPHORUS; POTASSIUM ASPARTATE; SODIUM MOLYBDATE; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANIUM; VANADIUM; YTTERBIUM OXIDE; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; LANTHANUM; NIOBIUM; TANTALUM; PROTEUS MORGANII</SubstanceName>
<StrengthNumber>3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 14; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>46708-586-31</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (46708-586-31) </PackageDescription>
<NDC11Code>46708-0586-31</NDC11Code>
<ProductNDC>46708-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214284</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride tablets do not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine hydrochloride tablets prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride tablets are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride tablets will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride tablets are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride tablets: 1 Amantadine hydrochloride tablets are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. , 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride tablets. .</IndicationAndUsage>
<Description>Amantadine hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride. Amantadine hydrochloride, USP is a stable white or practically white crystalline powder, freely soluble in water, soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each tablet intended for oral administration contains 100 mg amantadine hydrochloride, USP and has the following inactive ingredients: microcrystalline cellulose, povidone K-30, povidone K-90, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and FD&C Yellow No. 6 Aluminium Lake.</Description>
</NDC>
<NDC>
<NDCCode>46708-586-71</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (46708-586-71) </PackageDescription>
<NDC11Code>46708-0586-71</NDC11Code>
<ProductNDC>46708-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine</ProprietaryName>
<NonProprietaryName>Amantadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214284</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride tablets do not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine hydrochloride tablets prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride tablets are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride tablets will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride tablets are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride tablets: 1 Amantadine hydrochloride tablets are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. , 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride tablets. .</IndicationAndUsage>
<Description>Amantadine hydrochloride, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride. Amantadine hydrochloride, USP is a stable white or practically white crystalline powder, freely soluble in water, soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each tablet intended for oral administration contains 100 mg amantadine hydrochloride, USP and has the following inactive ingredients: microcrystalline cellulose, povidone K-30, povidone K-90, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and FD&C Yellow No. 6 Aluminium Lake.</Description>
</NDC>
<NDC>
<NDCCode>47335-586-08</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (47335-586-08) </PackageDescription>
<NDC11Code>47335-0586-08</NDC11Code>
<ProductNDC>47335-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091103</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2018-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg).</Description>
</NDC>
<NDC>
<NDCCode>47335-586-18</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (47335-586-18) </PackageDescription>
<NDC11Code>47335-0586-18</NDC11Code>
<ProductNDC>47335-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091103</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2018-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg).</Description>
</NDC>
<NDC>
<NDCCode>47335-586-83</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (47335-586-83) </PackageDescription>
<NDC11Code>47335-0586-83</NDC11Code>
<ProductNDC>47335-586</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eszopiclone</ProprietaryName>
<NonProprietaryName>Eszopiclone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091103</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ESZOPICLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2018-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).</IndicationAndUsage>
<Description>Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg).</Description>
</NDC>
</NDCList>